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Background: The authors evaluated the efficacy of liposome bupivacaine in a femoral nerve block (FNB) after total knee arthroplasty.Methods: Part 1: subjects received FNB with 20 ml liposome bupivacaine (67, 133, or 266 mg) or placebo. Part 2: subjects were randomized to FNB with liposome bupivacaine 266 mg or placebo. The primary outcome measure was area under the curve of the numeric rating scale score for pain intensity at rest through 72 h (AUC NRS-R0-72) with imputed scores after rescue medication.Results: In part 1, FNB with liposome bupivacaine 266 mg (n = 24) resulted in analgesia similar to that obtained with 133 mg and was chosen for part 2. In part 2, least-squares mean (standard error) AUC NRS-R0-72 was lower with liposome bupivacaine 266 mg (n = 92) than with placebo (n = 91; 419 [17] vs. 516 [17]; P < 0.0001). This outcome remained unchanged in a post hoc analysis without score imputation (221 [12] vs. 282 [12]; P = 0.0005). Least-squares mean AUC NRS-R with imputed scores was lower with liposome bupivacaine during each 24-h interval (0 to 24, 24 to 48, and 48 to 72 h) after surgery; AUC NRS-R without imputed scores was lower during the 0- to 24-h and 24- to 48-h intervals. The liposome bupivacaine group had lower mean total opioid use (76 vs. 103 mg morphine; P = 0.0016). Pain was sufficiently severe to require second-step rescue with opioids via intravenously administered patient-controlled analgesia in 92% of liposome bupivacaine patients and 81% of placebo patients. With patient-controlled analgesia and other forms of rescue analgesia, mean NRS scores with activity were moderate in both liposome bupivacaine and placebo groups throughout the part 2 study period. Incidence of adverse events was similar between the groups (part 1: 90 vs. 96%; part 2: 96 vs. 96%, respectively).Conclusion: FNB with liposome bupivacaine (266 mg) resulted in modestly lower pain scores and reduced opioid requirements after surgery, with an adverse event profile similar to placebo. [ABSTRACT FROM AUTHOR]

Background: Nonopioid management of postsurgical pain remains a major unmet need. Few studies have evaluated transient receptor potential vanilloid subfamily member 1 agonists for analgesia after surgery. This study examines intraoperative vocacapsaicin, a novel prodrug of the transient receptor potential vanilloid subfamily member 1 agonist capsaicin, in a validated model of postsurgical pain., Methods: This was a triple-blinded, randomized, placebo-controlled, dose-ranging trial in patients undergoing bunionectomy. Patients were randomized 1:1:1:1 to surgical site administration of 14 ml of placebo or one of three vocacapsaicin concentrations: 0.30, 0.15, or 0.05 mg/ml. The prespecified primary endpoint was the area-under-the-curve of the numerical rating scale pain score at rest through 96 h for the 0.30 mg/ml group. Prespecified ordered, secondary endpoints for the 0.30 mg/ml group included the percentage of patients who did not require opioids from 0 to 96 h, total opioid consumption through 96 h, and the area-under-the-curve of the numerical rating scale pain score for the first week., Results: The 147 patients were randomized. During the first 96 h, vocacapsaicin (0.30 mg/ml) reduced pain at rest by 33% versus placebo (primary endpoint, 95% CI [10%, 52%], effect size [Cohen's d] = 0.61, P = 0.005). Of patients receiving vocacapsaicin (0.30 mg/ml), 26% did not require postoperative opioids for analgesia (P = 0.025) versus 5% of patients receiving placebo. Vocacapsaicin (0.30 mg/ml) reduced opioid consumption over the first 96 h by 50% versus placebo (95% CI [26%, 67%], effect size = 0.76, P = 0.002). Vocacapsaicin (0.30 mg/ml) reduced pain over the first week by 37% versus placebo (95% CI [12%, 57%], effect size = 0.62, P = 0.004). The treatment effect persisted for at least 2 weeks. All study endpoints showed an administered concentration-versus-response relationship. Vocacapsaicin was well tolerated with no differences between groups in any safety parameter., Conclusions: A single, local administration of vocacapsaicin during surgery reduced pain and opioid consumption for at least 96 h after surgery compared to control., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc., on behalf of the American Society of Anesthesiologists.)

Competing Interests: Conflicts of Interest: The faculty received reimbursement for travel expenses attending the meeting. No honorarium was provided. T. J. Gan: Honoraria from Acacia, Edwards, Masimo, Medtronic, Merck and Mallinckrodt. S. Bergese: Acacia (Funding for Clinical Trial to Ohio State University). F. Chung has received research support from the Ontario Ministry of Health and Long-Term Care, University Health Network Foundation, Acacia Pharma, Medtronics grants to institution outside of the submitted work, Up-to-date royalties, STOP-Bang proprietary to University Health Network. Speaker honorarium from Baxter Pharma. P. Diemunsch: Ambu: Member of an advisors panel on airway management, Fisher & Paykel: Research Grants, paid conferences, French Government: Expert at the Court of Appeal, Acacia Pharma: Research Grants, MSD: Member of an advisory panel on ERAS. A. S. Habib: Funded Research: Pacira Biosciences, Avanos Medical Inc., Advisory Board: Takeda. A. L. Kovac: Merck (speaker’s bureau), Helsinn (speaker’s bureau), Mundipharma (speaker’s bureau), Acacia (speaker’s bureau). T. A. Meyer: Acacia, Neumentum. R. D. Urman: Merck (research funding); Medtronic (consulting fees and research funding); Takeda (consulting fees); Acacia (consulting fees and research funding); Posimir (consulting fees). S. Ayad: Pacira, Medtronic and Acacia. K. Candiotti: Research support-Acacia, Pfizer, Takeda; Consulting-Acacia, Pfizer, Takeda. T. L. Hedrick: MedEdicus. P. Kranke acted as investigator in phase III trials on amisulpride during the last 3 years. He gave invited lectures for FreseniusKabi (propofol), Grünenthal, CSL-Behring, TevaRatiopharm. H. S. Minkowitz: Acacia, AcelRX, Adynxx, Concentric, Durect, Heron, Merck, Mallinckrodt, Innocoll, Pacira, Neumentum, Westward, Trevena, Takeda. J. Morton: Medtronic, Olympus, Novo Nordisk.

Background: Complications with IV patient-controlled analgesia include programming errors, invasive access, and impairment of mobility. This study evaluated an investigational sufentanil sublingual tablet system (SSTS) for the management of pain after knee or hip arthroplasty., Methods: This prospective, randomized, parallel-arm, double-blind study randomized postoperative patients at 34 U.S. sites to receive SSTS 15 μg (n = 315) or an identical placebo system (n = 104) and pain scores were recorded for up to 72 h. Adult patients with American Society of Anesthesiologists status 1 to 3 after primary total unilateral knee or hip replacement under general anesthesia or with spinal anesthesia that did not include intrathecal opioids were eligible. Patients were excluded if they were opioid tolerant. The primary endpoint was the time-weighted summed pain intensity difference to baseline over 48 h. Secondary endpoints included total pain relief, patient and healthcare professional global assessments, and patient and nurse ease-of-care questionnaires., Results: Summed pain intensity difference (standard error) was higher (better) in the SSTS group compared with placebo (76 [7] vs. -11 [11], difference 88 [95% CI, 66 to 109]; P < 0.001). In the SSTS group, more patients and nurses responded "good" or "excellent" on the global assessments compared with placebo (P < 0.001). Patient and nurse ease-of-care ratings for the system were high in both groups. There was a higher incidence of nausea and pruritus in the SSTS group., Conclusion: SSTS could be an effective patient-controlled pain management modality in patients after major orthopedic surgery and is easy to use by both patients and healthcare professionals.

Background: Sugammadex is a modified gamma cyclodextrin compound which encapsulates rocuronium resulting in rapid reversal of residual neuromuscular blockade. We performed a post hoc analysis of data from a multicenter study designed to mimic standard clinical practice which would test the hypothesis that the presence (versus the absence) of a twitch response to neuromuscular stimulation at the time of reversal drug administration would influence the speed and completeness of the reversal effect of sugammadex., Methods: One-hundred-seventy-one consenting patients undergoing general anesthesia with a volatile-based anesthetic technique were enrolled in a multicenter observational study. All patients received rocuronium, 0.6 mg/kg i.v. for tracheal intubation and maintenance boluses of 0.15 mg/kg i.v. as needed during surgery. The degree of rocuronium-induced blockade was assessed during anesthesia using a TOF-Watch-SX acceleromyograph to record the train-of-four (TOF) responses on a laptop computer from induction of anesthesia until the TOF ratio returned to > or = 0.9 after completion of the surgical procedure. The patients received sugammadex, 4 mg/kg i.v., for reversal of neuromuscular blockade > 15 min after the last dose of rocuronium. Recovery data were compared in patients with either no (0) (n = 89) or > or = 1 twitch (n = 82) in response to TOF stimulation at the time of reversal drug administration., Results: The patients without a twitch response were more likely to be female (60% vs 40%) and had a shorter time interval between the last bolus dose of rocuronium and the administration of the reversal drug (31+/-18 vs 45+/-23 min, P < 0.05). The time to achieve a TOF ratio of 0.9 was prolonged in the 0 twitch group compared with the > or = 1 twitch response group (173+/-162 vs 104+/-73 s, P < 0.05). Overall, 84% of the patients in the 0 twitch group recovered to a TOF of 0.9 in < or = 5 min compared to 91% of the patients in the group with > or = 1 twitch (P < 0.05). The times to achieve a TOF of 0.9 varied from 0.8 to 22.3 and 0.7 to 8.5 min in the 0 twitch and > or = 1 twitch groups, respectively., Conclusion: Reversal of rocuronium-induced neuromuscular blockade by sugammadex was influenced by the degree of residual blockade at the time the reversal drug was administered. Despite the wide variability, reversal of the TOF ratio to 0.9 occurred < or = 5 min in more than 80% of the patients regardless of the number of twitches at the time of reversal drug administration.