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Journal of the American Academy of... May 2022Shoulder arthroscopy can result in substantial postoperative pain. Sucrose acetate isobutyrate extended-release bupivacaine (SABER-Bupivacaine; trade name Posimir) is a... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Shoulder arthroscopy can result in substantial postoperative pain. Sucrose acetate isobutyrate extended-release bupivacaine (SABER-Bupivacaine; trade name Posimir) is a novel depot formulation of bupivacaine designed to provide analgesia at the surgical site for up to 72 hours. The objective of this study was to evaluate the effect of SABER-Bupivacaine on pain and opioid consumption after arthroscopic subacromial decompression and to assess short-term and long-term safety.
METHODS
In this double-blind, placebo-controlled trial, 78 subjects were randomized in a 2:1 ratio to SABER-Bupivacaine 5 mL or SABER-placebo 5 mL injected into the subacromial space just before skin closure. Twenty-nine additional subjects were randomized on an exploratory basis to bupivacaine hydrochloride 20 mL, also injected subacromially. Subjects rated pain intensity on a 0 to 10 scale over the first 3 postoperative days and received intravenous or oral morphine for breakthrough pain. The coprimary efficacy end points were pain intensity on 90° shoulder flexion and cumulative morphine intake from 0 to 72 hours after surgery. The time to first use of opioid rescue analgesia was a secondary end point.
RESULTS
The mean (SD) pain intensity was 5.16 (1.94) for SABER-Bupivacaine and 6.43 (1.77) for placebo (P = 0.012). The median consumption of intravenous morphine equivalents was 4.0 mg for SABER-Bupivacaine and 12.0 mg for placebo (P = 0.010). The median time to first use of morphine rescue was 12.4 hours for SABER-Bupivacaine and 1.2 hours for placebo (P = 0.014). The corresponding values for bupivacaine hydrochloride were 5.16 (2.38), 8.0 mg, and 1.4 hours. The incidence and severity of treatment-emergent adverse events were similar for all treatment groups, and no functional or radiographic differences were noted at the 6-month follow-up.
DISCUSSION
Compared with placebo, SABER-Bupivacaine reduced pain and opioid analgesic consumption over 72 hours after arthroscopic subacromial decompression and prolonged the time to first use of opioid rescue analgesia. No safety signals were noted during the immediate postoperative period or at 6-month follow-up.
Topics: Analgesics, Opioid; Anesthetics, Local; Bupivacaine; Decompression; Humans; Morphine Derivatives; Pain, Postoperative
PubMed: 35584248
DOI: 10.5435/JAAOSGlobal-D-21-00287 -
Anesthesiology May 2024
Topics: Bupivacaine
PubMed: 38592361
DOI: 10.1097/ALN.0000000000004934 -
Pain Research & Management 2022Comparing bupivacaine's adjuvants in spinal anesthesia, we assessed the specific blocking characteristics and adverse effects of bupivacaine alone and in combination... (Randomized Controlled Trial)
Randomized Controlled Trial
Analgesic Characteristics of Bupivacaine Alone and in Combination with Dexmedetomidine or Meperidine in Spinal Anesthesia during Cesarean Section: A Double-Blind Randomized Clinical Trial Study.
BACKGROUND
Comparing bupivacaine's adjuvants in spinal anesthesia, we assessed the specific blocking characteristics and adverse effects of bupivacaine alone and in combination with dexmedetomidine or meperidine in spinal anesthesia during cesarean section.
METHODS
In this double-blind randomized clinical trial study, ninety pregnant women were divided into groups to receive 10 mg bupivacaine (group B), 10 mg bupivacaine with 5 g dexmedetomidine (group BD), or 10 mg bupivacaine with 10 mg meperidine (group BM) intrathecal. Patients were assessed for the quality of analgesia during operations. Durations of sensory and motor blocks and anesthesia-related complications were analyzed using SPSS 21, and values <0.05 were considered statistically significant.
RESULTS
The onset of sensory and motor blocks was essentially the same in all treated groups. Block regression time was significantly prolonged in the BD group compared to the B and BM groups ( < 0.001). The duration of analgesia was significantly longer in the BD and BM groups than in the B group ( < 0.001). The level of sedation in the BD group was higher than in the B group. Shivering occurred in 40% of patients in the B group, which was significantly more than that of the BD (16.6%) and BM (33.3%) groups. Itching happened in 33.3% of women in the BM group which was statistically more than that of the B (3.33%) and BD (0) groups. The incidence of adverse effects was the same in all groups.
CONCLUSION
The combination of bupivacaine with dexmedetomidine significantly prolonged sensory and motor regression time and duration of analgesia.
Topics: Analgesics; Anesthesia, Spinal; Anesthetics, Local; Bupivacaine; Cesarean Section; Dexmedetomidine; Double-Blind Method; Female; Humans; Injections, Spinal; Meperidine; Pain; Pregnancy
PubMed: 35899020
DOI: 10.1155/2022/5111214 -
Pain Research & Management 2021Brachial plexus block is frequently recommended for upper limb surgeries. Many drugs have been used as adjuvants to prolong the duration of the block. This study aimed...
BACKGROUND
Brachial plexus block is frequently recommended for upper limb surgeries. Many drugs have been used as adjuvants to prolong the duration of the block. This study aimed to assess the effect of dexmedetomidine with bupivacaine combination and only bupivacaine on sensory and motor block duration time, pain score, and hemodynamic variations in the supraclavicular block in upper extremity orthopedic surgery.
METHODS
This prospective, double-blind clinical trial study was conducted on 60 patients, 20 to 60 years old. Patients were candidates for upper extremity orthopedic surgeries. The sensory and motor block were evaluated by using the pinprick method and the modified Bromage scale. The postoperative pain was assessed by utilizing a visual analog scale.
RESULTS
The mean onset time of sensory and motor block in patients receiving only bupivacaine was, respectively, 31.03 ± 9.65 min and 24.66 ± 9.2 min, and in the dexmedetomidine receiving group, it was about 21.36 ± 8.34 min and 15.93 ± 6.36 minutes. The changes in heart rate and mean arterial blood pressure were similar in both groups. The duration of sensory and motor block and the time of the first analgesia request in the intervention group were longer. Postoperative pain was lower in the intervention group for 24 hours ( = 0.001).
CONCLUSION
Dexmedetomidine plus bupivacaine reduced the onset time of sense and motor blocks and increased numbness and immobility duration. Also, dexmedetomidine reduced postoperative pain significantly with the use of bupivacaine for supraclavicular blocks. . IRCT, IRCT20160430027677N15. Registered 05/28/2019, https://www.irct.ir/trial/39463.
Topics: Adult; Brachial Plexus Block; Bupivacaine; Dexmedetomidine; Double-Blind Method; Female; Humans; Hypnotics and Sedatives; Male; Middle Aged; Prospective Studies; Young Adult
PubMed: 33927790
DOI: 10.1155/2021/8858312 -
Anesthesiology Jan 2007Ropivacaine and levobupivacaine are local anesthetics that produce less motor block and greater sensory-motor separation when compared with equal milligram doses of... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Ropivacaine and levobupivacaine are local anesthetics that produce less motor block and greater sensory-motor separation when compared with equal milligram doses of bupivacaine. Although minimum local analgesic concentration studies suggested that they are less potent than bupivacaine, full dose-response studies have not been performed. The current trial describes the dose-response relation of levobupivacaine, ropivacaine, and bupivacaine, combined with sufentanil, when used for intrathecal labor analgesia.
METHODS
Four hundred fifty term parturients in active labor were included in this double-blind, randomized trial. Combined spinal-epidural anesthesia was performed, and ropivacaine, levobupivacaine, or bupivacaine was intrathecally administered in a dose of 1.0, 1.5, 2.0, 2.5, 3.0, or 3.5 mg, always combined with 1.5 microg sufentanil. Patients were considered responders to spinal analgesia if the visual analog scale score for pain was less than 25 mm within 15 min and the visual analog scale score remained less than 25 mm for 45 min. Patient demographics, obstetric data, maternal side effects, and fetal and neonatal well-being were noted. Group-specific dose-response curves were constructed using a probit regression model.
RESULTS
The ED95 of bupivacaine was 3.3 mg (95% confidence interval, 2.9-4.1). The ED95s of ropivacaine and levobupivacaine were 4.8 mg (95% confidence interval, 4.0-6.7) and 5.0 mg (95% confidence interval, 4.1-7.0), respectively. Racemic bupivacaine was significantly more potent than ropivacaine (P=0.0027) and levobupivacaine (P=0.0006). Ropivacaine and levobupivacaine were of similar potency (P=0.91).
CONCLUSIONS
This full dose-response study suggests that ropivacaine and levobupivacaine are of similar potency, whereas bupivacaine is more potent than both other drugs.
Topics: Adolescent; Adult; Amides; Analgesia, Epidural; Analgesia, Obstetrical; Anesthetics, Local; Bupivacaine; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Injections, Spinal; Levobupivacaine; Middle Aged; Pregnancy; Ropivacaine; Sufentanil
PubMed: 17197857
DOI: 10.1097/00000542-200701000-00024 -
Acta Cirurgica Brasileira Jul 2015To study racemic bupivacaine, non-racemic bupivacaine and ropivacaine on myocardial contractility. (Comparative Study)
Comparative Study
PURPOSE
To study racemic bupivacaine, non-racemic bupivacaine and ropivacaine on myocardial contractility.
METHODS
Isolated Wistar papillary muscles were submitted to 50 and 100 mM racemic bupivacaine (B50 and B100), non-racemic bupivacaine (NR50 and NR100) and ropivacaine (R50 and R100) intoxication. Isometric contraction data were obtained in basal condition (0.2 Hz), after increasing the frequency of stimulation to 1.0 Hz and after 5, 10 and 15 min of local anesthetic intoxication. Data were analyzed as relative changes of variation.
RESULTS
Developed tension was higher with R100 than B100 at D1 (4.3 ± 41.1 vs -57.9 ± 48.1). Resting tension was altered with B50 (-10.6 ± 23.8 vs -4.7 ± 5.0) and R50 (-14.0 ± 20.5 vs -0.5 ± 7.1) between D1 and D3. Maximum rate of tension development was lower with B100 (-56.6 ± 38.0) than R50 (-6.3 ± 37.9) and R100 (-1.9 ± 37.2) in D1. B50, B100 and NR100 modified the maximum rate of tension decline from D1 through D2. Time to peak tension was changed with NR50 between D1 and D2.
CONCLUSIONS
Racemic bupivacaine depressed myocardial contractile force more than non-racemic bupivacaine and ropivacaine. Non-racemic and racemic bupivacaine caused myocardial relaxation impairment more than ropivacaine.
Topics: Amides; Anesthetics, Local; Animals; Bupivacaine; Depression, Chemical; Male; Muscle Tonus; Myocardial Contraction; Papillary Muscles; Rats, Wistar; Reference Values; Ropivacaine; Stereoisomerism; Time Factors
PubMed: 26270140
DOI: 10.1590/S0102-865020150070000006 -
British Journal of Anaesthesia Aug 1982
Topics: Anesthesia, Local; Anesthesia, Spinal; Bupivacaine; Humans
PubMed: 7104129
DOI: 10.1093/bja/54.8.799 -
Anesthesiology Jun 2010We have compared the pharmacokinetics and brain distribution of lidocaine, racemic bupivacaine (bupivacaine), and levobupivacaine in awake, spontaneously breathing rats. (Comparative Study)
Comparative Study
BACKGROUND
We have compared the pharmacokinetics and brain distribution of lidocaine, racemic bupivacaine (bupivacaine), and levobupivacaine in awake, spontaneously breathing rats.
METHODS
Lidocaine (0.5 mg x kg x min), bupivacaine (0.1 mg x kg x min), or levobupivacaine (0.1 mg x kg x min) was continuously administered to rats for 2 h (n = 12, each anesthetic). Blood samples and cerebral dialysate were collected during infusion and for 2 h after termination of infusion. Concentrations of anesthetics in the cerebral extracellular fluid were measured by microdialysis using the retrodialysis calibration method. Tissue-to-plasma partition coefficients calculated from the total (protein-bound and unbound) and unbound concentrations in plasma and brain as well as pharmacokinetic parameters in plasma and cerebral extracellular fluid were compared among the three anesthetics.
RESULTS
There were no differences in plasma total or unbound concentrations between bupivacaine and levobupivacaine. Concentrations of bupivacaine in the cerebral extracellular fluid were significantly higher than levobupivacaine (P < 0.001). Despite no differences in the ratio of total brain concentration to total plasma concentration among the three anesthetics, the ratio of cerebral extracellular fluid concentration to plasma unbound fraction of bupivacaine was significantly higher than lidocaine and levobupivacaine (0.58 +/- 0.09, 0.47 +/- 0.18, and 0.40 +/- 0.09, respectively; P = 0.03 and 0.003, respectively).
CONCLUSIONS
Although the ratio of total brain concentration to total plasma concentrations of lidocaine, bupivacaine, and levobupivacaine was similar, concentration ratio of bupivacaine in the cerebral extracellular fluid to plasma unbound fraction was significantly higher than lidocaine and levobupivacaine.
Topics: Animals; Brain; Bupivacaine; Dose-Response Relationship, Drug; Extracellular Fluid; Levobupivacaine; Lidocaine; Male; Rats; Rats, Sprague-Dawley; Wakefulness
PubMed: 20460991
DOI: 10.1097/ALN.0b013e3181d9cc54 -
Anesthesiology Feb 2021Liposomal bupivacaine is purported to extend analgesia of peripheral nerve blocks when administered perineurally. However, evidence of the clinical effectiveness of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Liposomal bupivacaine is purported to extend analgesia of peripheral nerve blocks when administered perineurally. However, evidence of the clinical effectiveness of perineural liposomal bupivacaine is mixed. This meta-analysis seeks to evaluate the effectiveness of perineural liposomal bupivacaine in improving peripheral nerve block analgesia as compared with nonliposomal local anesthetics.
METHODS
The authors identified randomized trials evaluating the effectiveness of peripheral nerve block analgesic that compared liposomal bupivacaine with nonliposomal local anesthetics. The primary outcome was the difference in area under the receiver operating characteristics curve (AUC) of the pooled 24- to 72-h rest pain severity scores. Secondary outcomes included postoperative analgesic consumption, time to first analgesic request, incidence of opioid-related side effects, patient satisfaction, length of hospital stay, liposomal bupivacaine side effects, and functional recovery. AUC pain scores were interpreted in light of a minimal clinically important difference of 2.0 cm · h.
RESULTS
Nine trials (619 patients) were analyzed. When all trials were pooled, AUC pain scores ± SD at 24 to 72 h were 7.6 ± 4.9 cm · h and 6.6 ± 4.6 cm · h for nonliposomal and liposomal bupivacaine, respectively. As such, perineural liposomal bupivacaine provided a clinically unimportant benefit by improving the AUC (95% CI) of 24- to 72-h pain scores by 1.0 cm · h (0.5 to 1.6; P = 0.003) compared with nonliposomal bupivacaine. Excluding an industry-sponsored trial rendered the difference between the groups nonsignificant (0.7 cm · h [-0.1 to 1.5]; P = 0.100). Secondary outcome analysis did not uncover any additional benefits to liposomal bupivacaine in pain severity at individual timepoints up to 72 h, analgesic consumption, time to first analgesic request, opioid-related side effects, patient satisfaction, length of hospital stay, and functional recovery. No liposomal bupivacaine side effects were reported.
CONCLUSIONS
Perineural liposomal bupivacaine provided a statistically significant but clinically unimportant improvement in the AUC of postoperative pain scores compared with plain local anesthetic. Furthermore, this benefit was rendered nonsignificant after excluding an industry-sponsored trial, and liposomal bupivacaine was found to be not different from plain local anesthetics for postoperative pain and all other analgesic and functional outcomes. High-quality evidence does not support the use of perineural liposomal bupivacaine over nonliposomal bupivacaine for peripheral nerve blocks.
Topics: Analgesia; Anesthetics, Local; Bupivacaine; Humans; Liposomes; Nerve Block; Pain Management; Peripheral Nerves; Treatment Outcome
PubMed: 33372953
DOI: 10.1097/ALN.0000000000003651 -
Minerva Anestesiologica Apr 2017
Topics: Anesthesia, Spinal; Anesthetics, Local; Arthroplasty, Replacement, Hip; Bupivacaine; Levobupivacaine
PubMed: 28177207
DOI: 10.23736/S0375-9393.17.11874-2