-
Anaesthesiology Intensive Therapy 2024Neuraxial anaesthesia is a common choice for most hip and lower limb operations. Pain associated with positioning is often a deterrent, and the vast literature suggests... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Neuraxial anaesthesia is a common choice for most hip and lower limb operations. Pain associated with positioning is often a deterrent, and the vast literature suggests different regional blocks and opioids for these patients. Patients with acetabular fractures may experience increased pain, and thus are more difficult to position for the neuraxial block. We conducted a randomized controlled pilot study to assess and compare the analgesic efficacy of ultrasound-guided suprainguinal fascia iliaca block (SFICB) versus systemic fentanyl to facilitate positioning for combined spinal epidural (CSE) anaesthesia in patients undergoing acetabular fracture surgery.
MATERIAL AND METHODS
Twenty patients referred for surgical repair of acetabular fractures were randomly assigned to receive either ultrasound-guided SFICB (group B) or intravenous fentanyl (group F). Changes in visual analogue scale (VAS) scores in supine and sitting position, improvement in sitting angle (SA), positioning quality, rescue analgesic requirement, total opioid consumption, comfort VAS scores, and complications were noted to compare both groups.
RESULTS
The post-intervention VAS score in the sitting position was significantly lower in group B than in group F (5.9 ± 2.1 vs. 3.5 ± 1.5, P = 0.01). Group B also had more significant improvement in SA (27.5° (20.75-36.5°), in comparison to group F (10 (5-18.75), P = 0.006). The positioning quality was better in group B, with 70% of patients achieving an optimal position compared to only 10% in group F ( P = 0.02).
CONCLUSIONS
Ultrasound-guided SFICB, as compared to systemic fentanyl, provided better analgesia and helped to achieve a better and more comfortable position to perform the neuraxial block.
Topics: Humans; Pilot Projects; Male; Female; Ultrasonography, Interventional; Nerve Block; Acetabulum; Adult; Middle Aged; Fentanyl; Patient Positioning; Analgesics, Opioid; Fascia; Fractures, Bone; Anesthesia, Spinal; Pain Measurement; Anesthesia, Epidural
PubMed: 38741444
DOI: 10.5114/ait.2024.138554 -
Osteoarthritis and Cartilage Open Jun 2024The aim of this study was to compare the magnitude and the predictors of the placebo response in an internet versus onsite randomised controlled trials (RCTs) in people...
OBJECTIVE
The aim of this study was to compare the magnitude and the predictors of the placebo response in an internet versus onsite randomised controlled trials (RCTs) in people with hand osteoarthritis (HOA).
METHOD
This study is a analysis based on one internet RCT (RADIANT) and previously published onsite RCTs for HOA identified through a rigorous searching and selection strategy. The magnitude of the placebo response in the two different types of RCTs were compared using heterogeneity statistics and forest plots visualisation. Classic placebo predictors as well as a combined model, defined with data from onsite RCTs, were tested to predict the placebo response.
RESULTS
We analysed the dataset from RADIANT and fourteen previously published onsite RCTs. None of the analyses showed a significant difference between the placebo response for the internet versus onsite RCTs. The "classic" placebo predictors combined in a multivariate predictive model correlated significantly with the placebo response measured in RADIANT study.
CONCLUSION
Despite the absence of face-to-face interactions with the study personnel, there is no evidence that either the magnitude or the predictors of the placebo response of this internet RCT differ from those of onsite RCTs. This analysis is considered as a first step towards evaluating the difference between these designs and strengthens the argument that internet RCTs remain an acceptable alternative way to assess the efficacy of an active treatment in comparison to a placebo.
PubMed: 38737983
DOI: 10.1016/j.ocarto.2024.100474 -
Oncology Letters Jul 2024Flurbiprofen axetil or dezocine monotherapy has been applied for analgesia of postoperative non-small cell lung cancer (NSCLC); however, their combination is rarely...
Flurbiprofen axetil or dezocine monotherapy has been applied for analgesia of postoperative non-small cell lung cancer (NSCLC); however, their combination is rarely investigated. Consequently, the present study aimed to explore the effect of flurbiprofen axetil plus dezocine on postoperative pain, surgical outcomes and its safety profile in patients with NSCLC. A total of 150 patients with resectable NSCLC were enrolled and randomized into three groups: i) The flurbiprofen axetil plus dezocine group (n=50), ii) the flurbiprofen axetil group (n=51) and iii) the dezocine group (n=49). A total of 50 mg flurbiprofen axetil, 5 mg of dezocine or their combination were administered intravenously 3 h prior to surgery and subsequently every 12 h until day 3 (D3) following surgery. The postoperative pain was lower in the flurbiprofen axetil plus dezocine group compared with that of the flurbiprofen axetil group at 6 h (P=0.008), 12 h (P=0.003), day 1 (D1) (P=0.013), day 2 (D2) (P=0.036) and D3 (P=0.010); in addition, it was lower in the flurbiprofen axetil plus dezocine group compared with that of the dezocine group at 6 h (P=0.010), 12 h (P=0.012) and D1 (P=0.020). Patient-controlled analgesia consumption was also lower in the flurbiprofen axetil plus dezocine group compared with that of the flurbiprofen axetil (P=0.010) and dezocine (P=0.002) groups. Furthermore, the length of hospital stay was lower in the flurbiprofen axetil plus dezocine group compared with that of the flurbiprofen axetil (P=0.008) and dezocine (P=0.048) groups, while other surgical outcomes and adverse events were similar among these three groups. Moreover, the expression of tumor necrosis factor-α was lower in the flurbiprofen axetil plus dezocine group compared with that of the dezocine group at 12 h (P<0.001), D1 (P<0.001) and D3 (P=0.033). The data indicated that flurbiprofen axetil and dezocine combination was superior to monotherapy for postoperative analgesia in patients with resectable NSCLC.
PubMed: 38737980
DOI: 10.3892/ol.2024.14426 -
Anesthesiology and Pain Medicine Feb 2024Appropriate pain management promotes immediate mobilization and allows the parturient to adequately care for her neonate after cesarean section (CS).
Analgesic Effect of Quadratus Lumborum Block Type III and Type II Versus Lateral Transversus Abdominis Plane Block in Cesarean Section: A Randomized Controlled Multicenter Trial.
BACKGROUND
Appropriate pain management promotes immediate mobilization and allows the parturient to adequately care for her neonate after cesarean section (CS).
OBJECTIVES
This trial objective was to compare the type III and type II quadratus lumborum block (QLB) to transversus abdominis plane block (TAPB) regarding postoperative analgesic effect in CS.
METHODS
This randomized, controlled, single-blind trial involved 60 women presenting for CS under spinal anesthesia. The patients were assigned randomly to either the QLB type III, QLB type II, or lateral TAPB group. All blocks were performed using 20 mL of bupivacaine 0.25% bilaterally at the end of the operation with ultrasound guidance. Pain was assessed using the numerical rating scale (NRS) score at the post-anesthesia care unit (PACU) at 2, 4, 6, 8, 12, 18, and 24 hours. The level of patient satisfaction was graded on a 5-point Likert scale.
RESULTS
Numerical rating scale measurements at 6, 8, and 12 hours and total consumed meperidine in the 1st 24 hours after the operation were reduced significantly in QLB III than in QLB II and TAPB groups (P < 0.05) with an insignificant difference between the QLB II and TAPB groups (P > 0.05). The onset of the first request for analgesia was delayed significantly in QLB III, compared to QLB II and TAPB groups (P < 0.05), without a significant difference between the QLB II and TAPB groups (P > 0.05). Patient satisfaction and adverse events (e.g., postoperative nausea and vomiting, bradycardia, and hypotension) exhibited insignificant differences among the three groups (P > 0.05).
CONCLUSIONS
The QLB type III ensured better analgesia as evidenced by significantly lower pain measurements and amount of meperidine in the first 24 hours after the operation with delayed time of the first rescue analgesia in comparison to QLB II and TAPB; however, QLB II and TAPB were similar.
PubMed: 38737590
DOI: 10.5812/aapm-140464 -
Anesthesiology and Pain Medicine Feb 2024Postoperative pain management is crucial for improving patient outcomes following posterior cervical spine surgery. Opioids are effective but carry a risk of respiratory...
BACKGROUND
Postoperative pain management is crucial for improving patient outcomes following posterior cervical spine surgery. Opioids are effective but carry a risk of respiratory depression. Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used but may not provide adequate pain relief and have potential complications. The inter-semispinalis plane (ISPB) block is a novel technique for postoperative analgesia in cervical spine surgery.
OBJECTIVES
This study aims to evaluate and compare the efficacy of the ISPB with general anesthesia in terms of analgesia, postoperative Visual Analog Scale (VAS) pain scores, patient-surgeon satisfaction levels, and the occurrence of postoperative complications.
METHODS
This double-blind, randomized controlled trial was blinded to both the patient and the assessor. Fifty adult patients (18 - 60 years old) undergoing elective posterior cervical spine surgery were enrolled. The participants were divided into 2 groups: The ISPB group (receiving bilateral ultrasound-guided ISPB at the C5 level) and the control group (receiving general anesthesia only), with each group comprising 25 patients. The study assessed intraoperative fentanyl use, postoperative VAS pain levels, the need for rescue analgesia, and complications.
RESULTS
The ISPB group showed significantly lower intraoperative fentanyl consumption (median 100 vs. 100 - 150 μg, P = 0.022) and lower postoperative pain scores at 1, 8, 12, and 48 hours (P = 0.016, 0.009, 0.005, 0.016). Additionally, the ISPB group required less postoperative pethidine (20% vs. 64%, P = 0.002) and had a longer delay before requesting pethidine (hazard ratio 0.215, P = 0.001). Surgeon satisfaction was significantly higher in the ISPB group (P = 0.003). These results suggest that the ISPB can effectively reduce pain and analgesic requirements.
CONCLUSIONS
The ISPB is an effective analgesic technique for posterior cervical spine surgery, reducing opioid consumption, providing better pain control, and enhancing surgeon satisfaction without increasing complications. This approach has the potential to improve postoperative care and patient outcomes in this surgical population.
PubMed: 38725919
DOI: 10.5812/aapm-143369 -
Heliyon May 2024Epidural nonopioid adjuvants also reduce local anesthetic use. We aimed to test the hypothesis that, compared with the present standard fentanyl, the hourly consumption...
BACKGROUND
Epidural nonopioid adjuvants also reduce local anesthetic use. We aimed to test the hypothesis that, compared with the present standard fentanyl, the hourly consumption of local anesthetic was at least as good when dexmedetomidine or esketamine was combined with local anesthetic for patient-controlled epidural analgesia (PCEA).
METHODS
A total of 120 laboring nulliparous subjects requiring labor analgesia were recruited for the final statistical analysis. Subjects were randomized to receive 0.075 % ropivacaine added with one of three equivalent adjuvants: 0.4 μg/mL fentanyl, 0.4 μg/mL dexmedetomidine, or 1.0 mg/mL esketamine. The primary outcome was hourly ropivacaine consumption. Compared with the fentanyl group, a 20 % difference in hourly local anesthetic consumption between the dexmedetomidine and esketamine groups was considered a clinical difference (non-inferiority margin).
RESULTS
The hourly ropivacaine consumption of the fentanyl group was 12.4 (95 % confidence interval CI 11.2 to 13.6) ml/h, so the prespecified non-inferiority limit was 2.5 ml/h. The hourly ropivacaine consumption of the fentanyl group was not inferior to that of the dexmedetomidine group (12.4 ml/h vs. 11.9 ml/h, risk difference, 0.5; 95 % confidence interval CI, -1.0 to 2.0, meeting criteria for non-inferiority). However, the hourly ropivacaine consumption of the esketamine group was 14.3 ml/h, and that of the fentanyl group was 12.4 ml/h (risk difference, 1.9, 95 % CI, 0.2 to 3.6), failing to confirm non-inferiority with a non-inferiority margin of 20 %. The incidence of pruritus was highest in the fentanyl group, whereas the occurrence of mild dizziness was highest in the esketamine group.
CONCLUSIONS
In setting of the conditions of this study, epidural dexmedetomidine was non-inferior compared with epidural fentanyl in combination with ropivacaine for PCEA during labor. Meanwhile, we failed to establish the non-inferiority of epidural esketamine compared with epidural fentanyl in combination with ropivacaine for labor analgesia.
PubMed: 38707421
DOI: 10.1016/j.heliyon.2024.e30218 -
JTCVS Open Apr 2024Randomized control trials are considered the highest level of evidence, yet the scalability and practicality of implementing randomized control trials in the thoracic...
OBJECTIVE
Randomized control trials are considered the highest level of evidence, yet the scalability and practicality of implementing randomized control trials in the thoracic surgical oncology space are not well described. The aim of this study is to understand what types of randomized control trials have been conducted in thoracic surgical oncology and ascertain their success rate in completing them as originally planned.
METHODS
The ClinicalTrials.gov database was queried in April 2023 to identify registered randomized control trials performed in patients with lung cancer who underwent surgery (by any technique) as part of their treatment.
RESULTS
There were 68 eligible randomized control trials; 33 (48.5%) were intended to examine different perioperative patient management strategies (eg, analgesia, ventilation, drainage) or to examine different intraoperative technical aspects (eg, stapling, number of ports, port placement, ligation). The number of randomized control trials was relatively stable over time until a large increase in randomized control trials starting in 2016. Forty-four of the randomized control trials (64.7%) were open-label studies, 43 (63.2%) were conducted in a single facility, 66 (97.1%) had 2 arms, and the mean number of patients enrolled per randomized control trial was 236 (SD, 187). Of 21 completed randomized control trials (31%), the average time to complete accrual was 1605 days (4.4 years) and average time to complete primary/secondary outcomes and adverse events collection was 2125 days (5.82 years).
CONCLUSIONS
Given the immense investment of resources that randomized control trials require, these findings suggest the need to scrutinize future randomized control trial proposals to assess the likelihood of successful completion. Future study is needed to understand the various contributing factors to randomized control trial success or failure.
PubMed: 38690441
DOI: 10.1016/j.xjon.2024.01.008 -
Frontiers in Medicine 2024There is still a controversy about the superiority of liposomal bupivacaine (LB) over traditional local anesthetics in postoperative analgesia after thoracic surgery....
Effect of liposomal bupivacaine for preoperative erector spinae plane block on postoperative pain following video-assisted thoracoscopic lung surgery: a protocol for a multicenter, randomized, double-blind, clinical trial.
BACKGROUND
There is still a controversy about the superiority of liposomal bupivacaine (LB) over traditional local anesthetics in postoperative analgesia after thoracic surgery. This study aims to determine the effect of LB versus bupivacaine hydrochloride (HCl) for preoperative ultrasound-guided erector spinae plane block (ESPB) on postoperative acute and chronic pain in patients undergoing video-assisted thoracoscopic lung surgery.
METHODS
This multicenter, randomized, double-blind, controlled trial will include 272 adult patients scheduled for elective video-assisted thoracoscopic lung surgery. Patients will be randomly assigned, 1:1 and stratified by site, to the liposomal bupivacaine (LB) group or the bupivacaine (BUPI) HCl group. All patients will receive ultrasound-guided ESPB with either LB or bupivacaine HCl before surgery and patient-controlled intravenous analgesia (PCIA) as rescue analgesia after surgery. The numeric rating scale (NRS) score will be assessed after surgery. The primary outcome is the area under the curve of pain scores at rest for 0-72 h postoperatively. The secondary outcomes include the total amount of opioid rescue analgesics through 0-72 h postoperatively, time to the first press on the PCIA device as rescue analgesia, the area under the curve of pain scores on activity for 0-72 h postoperatively, NRS scores at rest and on activity at different time points during the 0-72 h postoperative period, Quality of Recovery 15 scores at 72 h after surgery, and NRS scores on activity on postsurgical day 14 and postsurgical 3 months. Adverse events after the surgery are followed up to the postsurgical day 7, including postoperative nausea and vomiting, fever, constipation, dizziness, headache, insomnia, itching, prolonged chest tube leakage, new-onset atrial fibrillation, severe ventricular arrhythmia, deep venous thrombosis, pulmonary embolism, pulmonary atelectasis, cardiac arrest, ileus, urinary retention, chylothorax, pneumothorax, and organ failure. Analyzes will be performed first according to the intention to treat principle and second with the per-protocol analysis.
DISCUSSION
We hypothesize that LB for preoperative ultrasound-guided ESPB would be more effective than bupivacaine HCl in reducing postoperative pain in video-assisted thoracoscopic lung surgery. Our results will contribute to the optimization of postoperative analgesia regimens for patients undergoing video-assisted thoracoscopic lung surgery.http://www.chictr.org.cn, identifier ChiCTR2300074852.
PubMed: 38681056
DOI: 10.3389/fmed.2024.1359878 -
BJA Open Jun 2024We hypothesised that a continuous 72-h bilateral parasternal infusion of lidocaine at 2×35 mg h would decrease pain and the inflammatory response after sternotomy for...
The effect of continuous bilateral parasternal block with lidocaine on patient-controlled analgesia opioid requirement and recovery after open heart surgery: a double-blind randomised controlled trial.
BACKGROUND
We hypothesised that a continuous 72-h bilateral parasternal infusion of lidocaine at 2×35 mg h would decrease pain and the inflammatory response after sternotomy for open heart surgery, subsequently improving quality of recovery.
METHODS
We randomly allocated 45 participants to a 72-h bilateral parasternal infusion of lidocaine or saline commencing after wound closure. The primary outcome was the cumulative patient-controlled analgesia (PCA) morphine consumption at 72 h. Secondary outcomes included total morphine requirement, pain, peak expiratory flow, and serum interleukin-6 concentration. In addition, we used an eHealth platform for a 3-month follow-up of pain, analgesic use, and Quality of Recovery-15 scores.
RESULTS
The 72-h PCA morphine requirement was significantly lower in the lidocaine than the saline group (10 mg [inter-quartile range: 5-19 mg] and 28.2 mg [inter-quartile range: 16-42.5 mg], respectively; =0.014). The total morphine requirement (including morphine administered before the start of PCA) was significantly lower at 24, 48, and 72 h. Pain was well controlled with no difference in pain scores between treatment groups. The peak expiratory flow was lower in the lidocaine group at 72 h. Interleukin-6 concentrations showed no difference at 24, 48, or 72 h. Quality of Recovery-15 scores did not differ between treatment groups at any time during the 3-month follow-up.
CONCLUSIONS
After sternotomy for open heart surgery, a 72-h bilateral parasternal lidocaine infusion significantly decreased PCA and total morphine requirement. However, neither signs of decreased inflammatory response nor an improvement in recovery was seen.
CLINICAL TRIAL REGISTRATION
EudraCT number 2018-004672-35.
PubMed: 38680128
DOI: 10.1016/j.bjao.2024.100279 -
Journal of Clinical Anesthesia Sep 2024We compared the analgesic effects of erector spinae plane block versus quadratus lumborum block following laparoscopic nephrectomy. (Randomized Controlled Trial)
Randomized Controlled Trial Comparative Study
STUDY OBJECTIVE
We compared the analgesic effects of erector spinae plane block versus quadratus lumborum block following laparoscopic nephrectomy.
DESIGN
A randomized controlled trial.
SETTING
A tertiary hospital in Beijing, China.
PATIENTS
Patients scheduled for elective laparoscopic nephrectomy.
INTERVENTIONS
A total of 110 patients were enrolled and randomized to receive either erector spinae plane block (n = 55) or quadratus lumborum block (n = 55) under ultrasound guidance. Patient-controlled sufentanil analgesia was provided after surgery.
MEASUREMENTS
Our primary outcome was cumulative opioid consumption within 24 h after surgery. Secondary outcomes included postoperative pain intensity, subjective sleep quality, and quality of recovery.
MAIN RESULTS
All 110 patients (mean 53 years, 57.3% female) were included in the intention-to-treat analysis. Cumulative sufentanil equivalent within 24 h was lower in patients given erector spinae plane block (median 13 μg, interquartile range 4 to 33) than in those given quadratus lumborum block (median 25 μg, interquartile range 13 to 39; median difference - 8 μg, 95% CI -15 to 0, P = 0.041). Pain intensity (0-10 range where 0 = no pain and 10 = the worst pain) at 2, 6, 12, and 24 h after surgery was lower with erector spinae plane block (at rest: median differences -1 point, all P ≤ 0.009; with movement: median differences -2 to -1 points, all P < 0.001). Subjective sleep quality on the night of surgery (the Richards-Campbell Sleep Questionnaire: 0-100 range, higher score better; median difference 12, 95% CI 2 to 23, P = 0.018) and quality of recovery at 24 h (the Quality of Recovery-15: 0-150 range, higher score better; median difference 8, 95% CI 2 to 15, P = 0.012) were better with erector spinae plane block. No procedure-related adverse events occurred.
CONCLUSIONS
Compared with quadratus lumborum block, erector spinae plane block provided better analgesia as manifested by lower opioid consumption and pain intensity for up to 24 h after laparoscopic nephrectomy.
Topics: Humans; Female; Nerve Block; Laparoscopy; Male; Middle Aged; Pain, Postoperative; Nephrectomy; Analgesics, Opioid; Adult; Ultrasonography, Interventional; Sufentanil; Abdominal Muscles; Pain Measurement; Analgesia, Patient-Controlled; Paraspinal Muscles; Aged; Treatment Outcome; Sleep Quality; Anesthetics, Local
PubMed: 38677191
DOI: 10.1016/j.jclinane.2024.111466