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International Journal of Colorectal... Jan 2021Closed perineal wounds often fail to heal by primary intention after abdomino-perineal resection (APR) and are often complicated by surgical site infection (SSI) and/or... (Review)
Review
The role of perineal application of prophylactic negative-pressure wound therapy for prevention of wound-related complications after abdomino-perineal resection: a systematic review.
BACKGROUND
Closed perineal wounds often fail to heal by primary intention after abdomino-perineal resection (APR) and are often complicated by surgical site infection (SSI) and/or wound dehiscence. Recent evidence showed encouraging results of prophylactic negative-pressure wound therapy (pNPWT) for prevention of wound-related complications in surgery. Our objective was to gather and discuss the early existing literature regarding the use of pNPWT to prevent wound-related complications on perineal wounds after APR.
METHODS
Medline, Embase, and Web of Science were searched for original publications and congress abstracts reporting the use of pNPWT after APR on closed perineal wounds.
RESULTS
Seven publications were included for analysis. Two publications reported significantly lower incidence of SSI in pNPWT patients than in controls with a risk reduction of about 25-30%. Two other publications described similar incidences of SSI between the two groups of patients but described SSI in pNPWT patients to be less severe. One study reported significantly lower incidence of wound dehiscence in pNPWT patients than in controls.
CONCLUSION
The largest non-randomized studies investigating the effect of pNPWT on the prevention of wound-related complications after APR showed encouraging results in terms of reduction of SSI and wound dehiscence that deserve further investigation and confirmation.
Topics: Humans; Negative-Pressure Wound Therapy; Perineum; Proctectomy; Rectal Neoplasms; Surgical Wound Infection; Wound Healing
PubMed: 32886194
DOI: 10.1007/s00384-020-03732-6 -
The Cochrane Database of Systematic... Jul 2016Many women experience perineal pain after childbirth, especially after having sustained perineal trauma. Perineal pain-management strategies are thus an important part... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Many women experience perineal pain after childbirth, especially after having sustained perineal trauma. Perineal pain-management strategies are thus an important part of postnatal care. Non-steroidal anti-inflammatory drugs (NSAIDs) are a commonly used type of medication in the management of postpartum pain and their effectiveness and safety should be assessed.
OBJECTIVES
To determine the effectiveness of a single dose of an oral NSAID for relief of acute perineal pain in the early postpartum period.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2016), OpenSIGLE, ProQuest Dissertations and Theses, the ISRCTN Registry and ClinicalTrials.gov (31 March 2016). We also reviewed reference lists of retrieved papers and contacted experts in the field.
SELECTION CRITERIA
Randomised controlled trials (RCTs) assessing a single dose of a NSAID versus a single dose of placebo, paracetamol or another NSAID for women with perineal pain in the early postpartum period. Quasi-RCTs and cross-over trials were excluded.
DATA COLLECTION AND ANALYSIS
Two review authors (FW and VS) independently assessed all identified papers for inclusion and risk of bias. Any discrepancies were resolved through discussion and consensus. Data extraction, including calculations of pain relief scores, was also conducted independently by two review authors and checked for accuracy.
MAIN RESULTS
We included 28 studies that examined 13 different NSAIDs and involved 4181 women (none of whom were breastfeeding). Studies were published between 1967 and 2013, with the majority published in the 1980s. Of the 4181 women involved in the studies, 2642 received a NSAID and 1539 received placebo or paracetamol. Risk of bias was generally unclear due to poor reporting, but in most studies the participants and personnel were blinded, outcome data were complete and the outcomes that were specified in the methods section were reported.None of the included studies reported on any of this review's secondary outcomes: prolonged hospitalisation or re-hospitalisation due to perineal pain; breastfeeding (fully or mixed) at discharge; breastfeeding (fully or mixed) at six weeks; perineal pain at six weeks; maternal views; postpartum depression; instrumental measures of disability due to perineal pain. NSAID versus placeboCompared to women who received a placebo, more women who received a single dose NSAID achieved adequate pain relief at four hours (risk ratio (RR) 1.91, 95% confidence interval (CI) 1.64 to 2.23, 10 studies, 1573 participants (low-quality evidence)) and adequate pain relief at six hours (RR 1.92, 95% CI 1.69 to 2.17, 17 studies, 2079 participants (very low-quality evidence)). Women who received a NSAID were also less likely to need additional analgesia compared to women who received placebo at four hours (RR 0.39, 95% CI 0.26 to 0.58, four studies, 486 participants (low-quality evidence)) and at six hours after initial administration (RR 0.32, 95% CI 0.26 to 0.40, 10 studies, 1012 participants (low-quality evidence)). Fourteen maternal adverse effects were reported in the NSAID group (drowsiness (5), abdominal discomfort (2), weakness (1), dizziness (2), headache (2), moderate epigastralgia (1), not specified (1)) and eight in the placebo group (drowsiness (2), light headed (1), nausea (1), backache (1), dizziness (1), epigastric pain (1), not specified (1)), although not all studies assessed adverse effects. There was no difference in overall maternal adverse effects between NSAIDs and placebo at six hours post-administration (RR 1.38, 95% CI 0.71 to 2.70, 13 studies, 1388 participants (very low-quality evidence)). One small study (with two treatment arms) assessed maternal adverse effects at four hours post-administration, but there were no maternal adverse effects observed (one study, 90 participants (low-quality evidence)). Neonatal adverse effects were not assessed in any of the included studies. NSAID versus paracetamolNSAIDs versus paracetamol were also more effective for adequate pain relief at four hours (RR 1.54, 95% CI 1.07 to 2.22, three studies, 342 participants) but not at six hours post-administration. There was no difference in the need for additional analgesia between the two groups at four hours (RR 0.55, 95% CI 0.27 to 1.13, one study, 73 participants), but women in the NSAID group were less likely to need any additional analgesia at six hours (RR 0.28, 95% CI 0.12 to 0.67, one study, 59 participants). No maternal adverse effects were reported four hours after drug administration (one study). Six hours post-administration, there was no difference between the groups in the number of maternal adverse effects (RR 0.74, 95% CI 0.27 to 2.08, three studies, 300 participants), with one case of pruritis in the NSAID group and one case of sleepiness in the paracetamol group. Neonatal adverse effects were not assessed in any of the included studies.Comparisons of different NSAIDs and different doses of the same NSAID did not demonstrate any differences in their effectiveness on any of the primary outcome measures; however, few data were available on some NSAIDs.
AUTHORS' CONCLUSIONS
In women who are not breastfeeding and who sustained perineal trauma, NSAIDs (compared to placebo) provide greater pain relief for acute postpartum perineal pain and fewer women need additional analgesia when treated with a NSAID. However, the risk of bias was unclear for many of the included studies, adverse effects were often not assessed and breastfeeding women were not included in the studies. The overall quality of the evidence (GRADE) was low with the evidence for all outcomes rated as low or very low. The main reasons for downgrading were inclusion of studies with high risk of bias and inconsistency of findings of individual studies.NSAIDs also appear to be more effective in providing relief for perineal pain than paracetamol, but few studies were included in this analysis.Future studies should examine NSAIDs' adverse effects profile including neonatal adverse effects and the compatibility of NSAIDs with breastfeeding, and assess other important secondary outcomes of this review. Moreover, studies mostly included women who had episiotomies. Future research should consider women with and without perineal trauma, including perineal tears. High-quality studies should be conducted to further assess the efficacy of NSAIDs versus paracetamol and the efficacy of multimodal treatments.
Topics: Acetaminophen; Administration, Oral; Analgesia; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Female; Humans; Neuralgia; Perineum; Postpartum Period; Pregnancy; Randomized Controlled Trials as Topic; Time Factors
PubMed: 27412362
DOI: 10.1002/14651858.CD011352.pub2 -
BMC Surgery Dec 2019This study aimed to identify and review associations between the types of sutures used for uterine compression suture (UCS) and its outcomes in postpartum hemorrhage.
BACKGROUND
This study aimed to identify and review associations between the types of sutures used for uterine compression suture (UCS) and its outcomes in postpartum hemorrhage.
METHODS
An electronic search using PubMed and Scopus databases was performed. We included the English articles reported from January 1, 1997, to May 31, 2017, using search words or terms regarding the types of suture and needle used for UCSs. We only included studies describing the sutures in the systematic review.
RESULTS
We found 196 studies and included 76 (38.8%) in our analysis. We collected data on maternal outcomes for 924 patients and categorized them. Of the 76 studies, suture sizes 0, 1, and 2 were used in 6, 44, and 32 articles, respectively (some studies used multiple sutures). Of the 45 studies mentioning the needles, curved and straight needles were used in 35 and 10, respectively. The results of our review revealed that about 80% of previous articles used Catgut and Polyglactin 910 sutures. Because no studies that compared the efficacy of different size of sutures were identified, we investigated the differences using the cases reported in previous studies mentioned above. In the first analysis, we compared the uterine preservation rate between size 1 and size 2 sutures. We found no significant difference in uterine preservation rate (92.8%: size 1 vs. 94.2%: size 2, p > 0.05) but found significant difference in transfusion rate (62.4% vs. 79.1%, p < 0.01). With the hypothesis that non-transfusion cases were less severe, we excluded these cases from second analysis. Although our second analysis of only Catgut or Polyglactin showed strong selection bias, we observed that uterine preservation rate was significantly higher in cases with size 2 suture than in those with size 1 suture (86.9% vs. 93.5%, p = 0.033).
CONCLUSIONS
Our systematic review showed that approximately 80% of cases were treated by Catgut and Polyglactin 910. Due to the heterogeneity of cases included in this review, it is difficult to estimate which suture is better for UCSs. More robust studies are necessary to enable the identification of the superior suture for performing UCSs.
Topics: Catgut; Female; Humans; Needles; Perineum; Polyglactin 910; Postpartum Hemorrhage; Pregnancy; Suture Techniques; Sutures; Uterus
PubMed: 31842850
DOI: 10.1186/s12893-019-0660-z -
World Journal of Surgery Nov 2015Use of topical antibiotics to improve perineal wound healing after abdominoperineal resection (APR) is controversial. The aim of this systematic review was to determine... (Review)
Review
BACKGROUND
Use of topical antibiotics to improve perineal wound healing after abdominoperineal resection (APR) is controversial. The aim of this systematic review was to determine the impact of local application of gentamicin on perineal wound healing after APR.
METHODS
The electronic databases Pubmed, EMBASE, and Cochrane library were searched in January 2015. Perineal wound outcome was categorized as infectious complications, non-infectious complications, and primary perineal wound healing.
RESULTS
From a total of 582 articles, eight studies published between 1988 and 2012 were included: four randomized controlled trials (RCTs), three comparative cohort studies, and one cohort study without control group. Gentamicin was administered using sponges (n = 3), beads (n = 4), and by local injection (n = 1). There was substantial heterogeneity regarding underlying disease, definition of outcome parameters and timing of perineal wound evaluation among the included studies, which precluded meta-analysis with pooling. Regarding infectious complications, three of six evaluable studies demonstrated a positive effect of local application of gentamicin: one of four RCTs and both comparative cohort studies. Only two RCTs reported on non-infectious complications, showing no significant impact of gentamicin sponge. All three comparative cohort studies demonstrated a significantly higher percentage of primary perineal wound healing after local application of gentamicin beads, but only one out of three evaluable RCTs did show a positive effect of gentamicin sponges.
CONCLUSION
Currently available evidence does not support perineal gentamicin application after APR.
Topics: Abdomen; Anti-Bacterial Agents; Antibiotic Prophylaxis; Gentamicins; Humans; Perineum; Rectal Neoplasms; Surgical Wound Infection; Wound Healing
PubMed: 26170157
DOI: 10.1007/s00268-015-3159-5 -
BMC Pregnancy and Childbirth Aug 2022The World Health Organization in recent years has emphasized reducing the possibility of unnecessary interventions in natural childbirth, but little is known about the... (Meta-Analysis)
Meta-Analysis
BACKGROUND
The World Health Organization in recent years has emphasized reducing the possibility of unnecessary interventions in natural childbirth, but little is known about the accuracy of non-invasive methods when assessing the progress of labor. This paper presents a literature review to assess strategies that support non-invasive methods for labor during the first stage. It evaluates the available evidence to provide the most suitable assessments and predictions that objectively identify the progress of low-risk labor during the first stage of labor.
METHODS
A search for relevant literature was conducted using the electronic databases of PubMed, CINAHL, Web of Sciences, the Cochrane Library, Scopus, Medline (OVID), and CEPS, with publications up to November 2021. Records were screened against pre-specified inclusion/exclusion criteria and the potential papers from Google Scholar were examined to identify additional papers that may have been missed. The Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool was used to appraise the methodological quality of the included studies. The certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Two independent investigators extracted the review's characteristics, and discrepancies were resolved by consensus. This review calculated individual and pooled sensitivity, specificity, and positive predictive values, which were exported to STATA (version 14; Stata Corp., College Station, TX) to represent the performance of diagnostic testing.
RESULTS
Our search returned 2283 reports of which 13 fulfilled the inclusion criteria, accounting for 2594 women. The subjects were divided into groups according to the diagnostic tests used to assess the progress of their labor, including appearance assessment and sonographic imaging parameters (head perineum distance, HPD; angle of progression, AOP, and other parameters). HPD pooled sensitivity was 0.74 (0.65-0.82), and specificity was 0.77 (0.69-0.84). The pooled diagnostic odds ratio (DOR) was 8.21 (4.67-14.41) and 10.34 (5.02-21.27), respectively. The results of subgroup analysis showed that the summary sensitivity and specificity were of medium accuracy overall. The quality of evidence as assessed with GRADE was low.
CONCLUSION
Vaginal examination is an intrinsic element in the use of the partogram, while transperineal ultrasound can also be used as an auxiliary tool. However, the presence of publication bias within the parameters of ultrasound indicates that the diagnostic performance may be overestimated. Thus, randomized controlled trials or large-scale prospective cohort studies are necessary.
Topics: Female; Humans; Labor, Obstetric; Perineum; Pregnancy; Prospective Studies; Sensitivity and Specificity; Ultrasonography
PubMed: 35915400
DOI: 10.1186/s12884-022-04938-y -
PloS One 2020Both nationally and internationally, midwives' practices during the second stage of labour vary. A midwife's practice can be influenced by education and cultural...
Both nationally and internationally, midwives' practices during the second stage of labour vary. A midwife's practice can be influenced by education and cultural practices but ultimately it should be informed by up-to-date scientific evidence. We conducted a systematic review of the literature to retrieve evidence that supports high quality intrapartum care during the second stage of labour. A systematic literature search was performed to September 2019 in collaboration with a medical information specialist. Bibliographic databases searched included: PubMed, EMBASE, Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, Maternity and Infant Care Database and The Cochrane Library, resulting in 6,382 references to be screened after duplicates were removed. Articles were then assessed for quality by two independent researchers and data extracted. 17 studies focusing on midwives' practices during physiological second stage of labour were included. Two studies surveyed midwives regarding their practice and one study utilising focus groups explored how midwives facilitate women's birthing positions, while another focus group study explored expert midwives' views of their practice of preserving an intact perineum during physiological birth. The remainder of the included studies were primarily intervention studies, highlighting aspects of midwifery practice during the second stage of labour. The empirical findings were synthesised into four main themes namely: birthing positions, non-pharmacological pain relief, pushing techniques and optimising perineal outcomes; the results were outlined and discussed. By implementing this evidence midwives may enable women during the second stage of labour to optimise physiological processes to give birth. There is, however, a dearth of evidence relating to midwives' practice, which provides a positive experience for women during the second stage of labour. Perhaps this is because not all midwives' practices during the second stage of labour are researched and documented. This systematic review provides a valuable insight of the empirical evidence relating to midwifery practice during the physiological second stage of labour, which can also inform education and future research. The majority of the authors were members of the EU COST Action IS1405: Building Intrapartum Research Through Health (BIRTH). The study protocol is registered in the International Prospective Register of Systematic Reviews (PROSPERO; Registration CRD42018088300) and is published (Verhoeven, Spence, Nyman, Otten, Healy, 2019).
Topics: Female; Focus Groups; Humans; Labor Stage, Second; Midwifery; Patient Positioning; Perineum; Pregnancy; Quality of Health Care
PubMed: 32722680
DOI: 10.1371/journal.pone.0226502 -
Polski Przeglad Chirurgiczny Apr 2022<b>Introduction:</b> Perineal hernia (PH), also termed pelvic floor hernia, is a protrusion of intraabdominal viscera into the perineum through a defect in...
<b>Introduction:</b> Perineal hernia (PH), also termed pelvic floor hernia, is a protrusion of intraabdominal viscera into the perineum through a defect in the pelvic floor. </br></br> <b>Aim:</b> The study was conducted to evaluate the cases of perineal hernia resulting as a complication of abdominoperineal resection (APR) of rectal cancer. </br></br> <b> Material and methods:</b> 30 cases from 24 articles published in reputable peer reviewed journals were evaluated for eight variables including [I] patient age, [II] gender, [III] time since APR, [IV] clinical presentation, [V] approach to repair, [VI] type of repair, [VII] presence/absence of pelvic adhesions [VIII] complications. </br></br> <b>Results:</b> There was a total of 30 cases (18 males and 12 females) with a mean age of 71.5 years. The time of onset of symptoms ranged from 6 days to 12 years. Perineal lump with pain was the chief presenting feature followed by intestinal obstruction. Different approaches were adopted to repair by various methods. </br></br> <b>Conclusions:</b> Perineal hernia as a complication of abdominoperineal resection is reported increasingly nowadays, as the approach to management of rectal cancer has gradually got shifted from open to minimally invasive in recent years. There is a need to spread awareness about this condition, so that it is actively looked for, during the postoperative follow-up. Management is surgical repair; the approach and type of repair should be individualized.
Topics: Female; Male; Humans; Aged; Proctectomy; Rectal Neoplasms; Intestinal Obstruction; Abdominal Cavity; Hernia
PubMed: 36468514
DOI: 10.5604/01.3001.0015.7677 -
International Journal of Surgery... 2013This best evidence topic was investigated according to a described protocol. The question posed was: should the irradiated perineal wound following abdominoperineal... (Review)
Review
This best evidence topic was investigated according to a described protocol. The question posed was: should the irradiated perineal wound following abdominoperineal resection (APR) be closed with primary repair or a myocutaneous flap. Using the reported search 364 papers were found of which eight represented the best evidence to answer the clinical question. The conclusion drawn is that there is some limited evidence for recommending flap closure in abdominoperineal resection post radiotherapy. The best evidence available was from a systematic review of cohort studies and case series. Although no meta-analysis was performed, overall wound healing was improved using flap closure with a low frequency of flap necrosis. Other studies providing evidence were case-control series or cohort studies. Three papers prospectively compared vertical rectus abdominus muscle (VRAM) flap with primary closure; two of which demonstrated statistically significant improvement in complication rates with flap closure. Two retrospective case control series showed significant improvement in major wound complication rates in the flap group. Two studies retrospectively compared gracilis flap repair with primary closure and showed significantly lower incidence of major perineal complications. Most studies suffered from significant limitations, small sample sizes and no direct comparisons between matched groups with respect to type of anatomic flap, wound size, tumour recurrence or radiation dose. Whilst there is evidence that myocutaneous flap closure following APR in radiotherapy patients can reduce wound related complications, prospective randomized controlled trials are warranted.
Topics: Abdomen; Cohort Studies; Humans; Perineum; Rectal Neoplasms; Surgical Flaps; Wound Closure Techniques; Wound Healing
PubMed: 23707627
DOI: 10.1016/j.ijsu.2013.05.004 -
The Cochrane Database of Systematic... Jul 2020Perineal trauma, due to spontaneous tears, surgical incision (episiotomy), or in association with operative vaginal birth, is common after vaginal birth, and is often... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Perineal trauma, due to spontaneous tears, surgical incision (episiotomy), or in association with operative vaginal birth, is common after vaginal birth, and is often associated with postpartum perineal pain. Birth over an intact perineum may also lead to perineal pain. There are adverse health consequences associated with perineal pain for the women and their babies in the short- and long-term, and the pain may interfere with newborn care and the establishment of breastfeeding. Aspirin has been used in the management of postpartum perineal pain, and its effectiveness and safety should be assessed. This is an update of the review, last published in 2017.
OBJECTIVES
To determine the effects of a single dose of aspirin (acetylsalicylic acid), including at different doses, in the relief of acute postpartum perineal pain.
SEARCH METHODS
For this update, we searched the Cochrane Pregnancy and Childbirth's Trials Register (4 October 2019), ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (4 October 2019) and screened reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs), assessing single dose aspirin compared with placebo, no treatment, a different dose of aspirin, or single dose paracetamol or acetaminophen, for women with perineal pain in the early postpartum period. We planned to include cluster-RCTs, but none were identified. We excluded quasi-RCTs and cross-over studies.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of the included RCTs. Data were checked for accuracy. The certainty of the evidence for the main comparison (aspirin versus placebo) was assessed using the GRADE approach.
MAIN RESULTS
We included 17 RCTs, 16 of which randomised 1132 women to aspirin or placebo; one RCT did not report numbers of women. Two RCTs (of 16) did not contribute data to meta-analyses. All women had perineal pain post-episiotomy, and were not breastfeeding. Studies were published between 1967 and 1997, and the risk of bias was often unclear, due to poor reporting. We included four comparisons: aspirin versus placebo (15 RCTs); 300 mg versus 600 mg aspirin (1 RCT); 600 mg versus 1200 mg aspirin (2 RCTs); and 300 mg versus 1200 mg aspirin (1 RCT). Aspirin versus placebo Aspirin may result in more women reporting adequate pain relief four to eight hours after administration compared with placebo (risk ratio (RR) 2.03, 95% confidence interval (CI) 1.69 to 2.42; 13 RCTs, 1001 women; low-certainty evidence). It is uncertain whether aspirin compared with placebo has an effect on the need for additional pain relief (RR 0.25, 95% CI 0.17 to 0.37; 10 RCTs, 744 women; very low-certainty evidence), or maternal adverse effects (RR 1.08, 95% CI 0.57 to 2.06; 14 RCTs, 1067 women; very low-certainty evidence), four to eight hours after administration. Analyses based on dose did not reveal any clear subgroup differences. 300 mg versus 600 mg aspirin It is uncertain whether over four hours after administration, 300 mg compared with 600 mg aspirin has an effect on adequate pain relief (RR 0.82, 95% CI 0.36 to 1.86; 1 RCT, 81 women) or the need for additional pain relief (RR 0.68, 95% CI 0.12 to 3.88; 1 RCT, 81 women). There were no maternal adverse effects in either aspirin group. 600 mg versus 1200 mg aspirin It is uncertain whether over four to eight hours after administration, 600 mg compared with 1200 mg aspirin has an effect on adequate pain relief (RR 0.85, 95% CI 0.52 to 1.39; 2 RCTs, 121 women), the need for additional pain relief (RR 1.32, 95% CI 0.30 to 5.68; 2 RCTs, 121 women), or maternal adverse effects (RR 3.00, 95% CI 0.13 to 69.52; 2 RCTs, 121 women). 300 mg versus 1200 mg aspirin It is uncertain whether over four hours after administration, 300 mg compared with 1200 mg aspirin has an effect on adequate pain relief (RR 0.62, 95% CI 0.29 to 1.32; 1 RCT, 80 women) or need for additional pain relief (RR 2.00, 95% CI 0.19 to 21.18; 1 RCT, 80 women). There were no maternal adverse effects in either aspirin group. None of the included RCTs reported on neonatal adverse effects. No RCTs reported on secondary review outcomes of: prolonged hospitalisation due to perineal pain; re-hospitalisation due to perineal pain; fully breastfeeding at discharge; mixed feeding at discharge; fully breastfeeding at six weeks; mixed feeding at six weeks; perineal pain at six weeks; maternal views; or maternal postpartum depression.
AUTHORS' CONCLUSIONS
Single dose aspirin may increase adequate pain relief in women with perineal pain post-episiotomy compared with placebo. It is uncertain whether aspirin has an effect on the need for additional analgesia, or on maternal adverse effects, compared with placebo. We downgraded the certainty of the evidence because of study limitations (risk of bias), imprecision, and publication bias. Aspirin may be considered for use in non-breastfeeding women with post-episiotomy perineal pain. Included RCTs excluded breastfeeding women, so there was no evidence to assess the effects of aspirin on neonatal adverse effects or breastfeeding. Future RCTs should be designed to ensure low risk of bias, and address gaps in the evidence, such as the secondary outcomes established for this review. Current research has focused on women with post-episiotomy pain; future RCTs could be extended to include women with perineal pain associated with spontaneous tears or operative birth.
Topics: Acute Pain; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Episiotomy; Female; Humans; Obstetric Labor Complications; Pain, Postoperative; Perineum; Placebo Effect; Postpartum Period; Pregnancy; Randomized Controlled Trials as Topic; Time Factors
PubMed: 32702783
DOI: 10.1002/14651858.CD012129.pub3 -
The Cochrane Database of Systematic... Jan 2021Many women experience perineal pain after childbirth, especially after having sustained perineal trauma. Perineal pain-management strategies are an important part of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Many women experience perineal pain after childbirth, especially after having sustained perineal trauma. Perineal pain-management strategies are an important part of postnatal care. Non-steroidal anti-inflammatory drugs (NSAIDs) are a commonly-used type of medication in the management of postpartum pain, and their effectiveness and safety should be assessed. This is an update of a review first published in 2016.
OBJECTIVES
To determine the effectiveness of a single dose of an oral NSAID for relief of acute perineal pain in the early postpartum period.
SEARCH METHODS
For this update, we searched the Cochrane Pregnancy and Childbirth Group's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (9 December 2019), OpenSIGLE and ProQuest Dissertations and Theses (28 February 2020), and reference lists of retrieved studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) assessing a single dose of a NSAID versus a single dose of placebo, paracetamol or another NSAID for women with perineal pain in the early postpartum period. We excluded quasi-RCTs and cross-over trials. We included papers in abstract format only if they had sufficient information to determine that they met the review's prespecified inclusion criteria.
DATA COLLECTION AND ANALYSIS
Two review authors (FW and VS) independently assessed all identified papers for inclusion and risks of bias, resolving any discrepancies through discussion. Two review authors independently conducted data extraction, including calculations of pain relief scores, and checked it for accuracy. We assessed the certainty of the evidence using the GRADE approach.
MAIN RESULTS
We included 35 studies examining 16 different NSAIDs and involving 5136 women (none were breastfeeding). Studies were published between 1967 and 2013. Risk of bias due to random sequence generation, allocation concealment and blinding of outcome assessors was generally unclearly to poorly reported, but participants and caregivers were blinded, and outcome data were generally complete. We downgraded the certainty of evidence due to risk of bias, suspected publication bias, and imprecision for small numbers of participants. NSAID versus placebo Compared to women who receive a placebo, more women who receive a single-dose NSAID may achieve adequate pain relief at four hours (risk ratio (RR) 1.91, 95% confidence interval (CI) 1.64 to 2.23; 10 studies, 1573 women; low-certainty evidence) and at six hours (RR 1.92, 95% CI 1.69 to 2.17; 17 studies, 2079 women; very low-certainty evidence), although we are less certain about the effects at six hours. At four hours after administration, women who receive a NSAID are probably less likely to need additional analgesia compared to women who receive placebo (RR 0.39, 95% CI 0.26 to 0.58; 4 studies, 486 women; moderate-certainty evidence) and may be less likely to need additional analgesia at six hours after initial administration, although the evidence was less certain at six hours (RR 0.32, 95% CI 0.26 to 0.40; 10 studies, 1012 women; very low-certainty evidence). One study reported that no adverse events were observed at four hours post-administration (90 women). There may be little or no difference in maternal adverse effects between NSAIDs and placebo at six hours post-administration (RR 1.38, 95% CI 0.71 to 2.70; 13 studies, 1388 women; low-certainty evidence). Fourteen maternal adverse effects were reported in the NSAID group (drowsiness (5), abdominal discomfort (2), weakness (1), dizziness (2), headache (2), moderate epigastralgia (1), not specified (1)) and eight in the placebo group (drowsiness (2), light-headedness (1), nausea (1), backache (1), dizziness (1), epigastric pain (1), not specified (1)), although not all studies assessed adverse effects. Neonatal adverse effects were not assessed in any of the studies. NSAID versus paracetamol NSAIDs may lead to more women achieving adequate pain relief at four hours, compared with paracetamol (RR 1.54, 95% CI 1.07 to 2.22; 3 studies, 342 women; low-certainty evidence). We are uncertain if there is any difference in adequate pain relief between NSAIDs and paracetamol at six hours post-administration (RR 1.82, 95% CI 0.61 to 5.47; 2 studies, 99 women; very low-certainty evidence) or in the need for additional analgesia at four hours (RR 0.55, 95% CI 0.27 to 1.13; 1 study, 73 women; very low-certainty evidence). NSAIDs may reduce the risk of requiring additional analgesia at six hours compared with paracetamol (RR 0.28, 95% CI 0.12 to 0.67; 1 study, 59 women; low-certainty evidence). One study reported that no maternal adverse effects were observed at four hours post-administration (210 women). Six hours post-administration, we are uncertain if there is any difference between groups in the number of maternal adverse effects (RR 0.74, 95% CI 0.27 to 2.08; 3 studies, 300 women; very low-certainty evidence), with one case of pruritis in the NSAID group and one case of sleepiness in the paracetamol group. Neonatal adverse effects were not assessed in any of the included studies. Comparisons of different NSAIDs or doses did not demonstrate any differences in effectiveness for any primary outcome measures; however, few data were available on some NSAIDs. None of the included studies reported on any of this review's secondary outcomes.
AUTHORS' CONCLUSIONS
In women who are not breastfeeding and who sustained perineal trauma, NSAIDs (compared to placebo or paracetamol) may provide greater pain relief for acute postpartum perineal pain and fewer women need additional analgesia, but uncertainty remains, as the evidence is rated as low- or very low-certainty. The risk of bias was unclear for many studies, adverse effects were often not assessed and breastfeeding women were not included. While this review provides some indication of the likely effect, there is uncertainty in our conclusions. The main reasons for downgrading were the inclusion of studies at high risk of bias and inconsistency in the findings of individual studies. Future studies could examine NSAIDs' adverse effects, including neonatal effects and the compatibility of NSAIDs with breastfeeding, and could assess other secondary outcomes. Future research could consider women with and without perineal trauma, including perineal tears. High-quality studies could be conducted to further assess the efficacy of NSAIDs versus paracetamol and the efficacy of multimodal treatments.
Topics: Acetaminophen; Administration, Oral; Analgesia; Analgesics, Non-Narcotic; Anti-Inflammatory Agents, Non-Steroidal; Female; Humans; Neuralgia; Perineum; Postpartum Period; Pregnancy; Randomized Controlled Trials as Topic; Time Factors
PubMed: 33427305
DOI: 10.1002/14651858.CD011352.pub3