Dataset Information

HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the phase 3 EPOCH 2 study.

ABSTRACT: PURPOSE:Currently available local anesthetics have not demonstrated sufficient analgesia beyond 12-24 h postoperatively. The purpose of the study was to assess the safety and efficacy of HTX-011 (bupivacaine and meloxicam in Biochronomer® polymer technology), a long-acting investigational anesthetic, in reducing both postoperative pain over 72 h and postoperative opioid use compared to bupivacaine hydrochloride (HCl). METHODS:A phase 3, randomized, double-blind, active-controlled multi-center study (EPOCH 2; NCT03237481) in subjects undergoing unilateral open inguinal herniorrhaphy with mesh placement was performed. Subjects randomly received a single intraoperative dose of HTX-011, immediate-release bupivacaine HCl, or saline placebo prior to closure. RESULTS:The study evaluated 418 subjects, and the primary and all key secondary efficacy endpoints were in favor of HTX-011. HTX-011 reduced mean pain intensity by 23% versus placebo (primary endpoint; p?

SUBMITTER: Viscusi E

PROVIDER: S-EPMC6938470 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the phase 3 EPOCH 2 study.

Viscusi E E Minkowitz H H Winkle P P Ramamoorthy S S Hu J J Singla N N

Hernia : the journal of hernias and abdominal wall surgery 20190819 6

<h4>Purpose</h4>Currently available local anesthetics have not demonstrated sufficient analgesia beyond 12-24 h postoperatively. The purpose of the study was to assess the safety and efficacy of HTX-011 (bupivacaine and meloxicam in Biochronomer<sup>®</sup> polymer technology), a long-acting investigational anesthetic, in reducing both postoperative pain over 72 h and postoperative opioid use compared to bupivacaine hydrochloride (HCl).<h4>Methods</h4>A phase 3, randomized, double-blind, active- ...[more]

PMID: 31429023

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Project description:IntroductionShoulder 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.MethodsIn 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.ResultsThe 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.DiscussionCompared 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.

Project description:ImportanceSurgeons must balance management of acute postoperative pain with opioid stewardship. Patient-centered methods that immediately evaluate pain and opioid consumption can be used to guide prescribing and shared decision-making.ObjectiveTo assess the difference between the number of opioid tablets prescribed and the self-reported number of tablets taken as well as self-reported pain intensity and ability to manage pain after orthopedic and urologic procedures with use of an automated text messaging system.Design, setting, and participantsThis quality improvement study was conducted at a large, urban academic health care system in Pennsylvania. Adult patients (aged ≥18 years) who underwent orthopedic and urologic procedures and received postoperative prescriptions for opioids were included. Data were collected prospectively using automated text messaging until postoperative day 28, from May 1 to December 31, 2019.Main outcomes and measuresThe primary outcome was the difference between the number of opioid tablets prescribed and the patient-reported number of tablets taken (in oxycodone 5-mg tablet equivalents). Secondary outcomes were self-reported pain intensity (on a scale of 0-10, with 10 being the highest level of pain) and ability to manage pain (on a scale of 0-10, with 10 representing very able to control pain) after orthopedic and urologic procedures.ResultsOf the 919 study participants, 742 (80.7%) underwent orthopedic procedures and 177 (19.2%) underwent urologic procedures. Among those who underwent orthopedic procedures, 384 (51.8%) were women, 491 (66.7%) were White, and the median age was 48 years (interquartile range [IQR], 32-61 years); 514 (69.8%) had an outpatient procedure. Among those who underwent urologic procedures, 145 (84.8%) were men, 138 (80.7%) were White, and the median age was 56 years (IQR, 40-67 years); 106 (62%) had an outpatient procedure. The mean (SD) pain score on day 4 after orthopedic procedures was 4.72 (2.54), with a mean (SD) change by day 21 of -0.40 (1.91). The mean (SD) ability to manage pain score on day 4 was 7.32 (2.59), with a mean (SD) change of -0.80 (2.72) by day 21. The mean (SD) pain score on day 4 after urologic procedures was 3.48 (2.43), with a mean (SD) change by day 21 of -1.50 (2.12). The mean (SD) ability to manage pain score on day 4 was 7.34 (2.81), with a mean (SD) change of 0.80 (1.75) by day 14. The median quantity of opioids prescribed for patients who underwent orthopedic procedures was high compared with self-reported consumption (20 tablets [IQR, 15-30 tablets] vs 6 tablets used [IQR, 0-14 tablets]), similar to findings for patients who underwent urologic procedures (7 tablets [IQR, 5-10 tablets] vs 1 tablet used [IQR, 0-4 tablets]). Over the study period, 9452 of 15 581 total tablets prescribed (60.7%) were unused. A total of 589 patients (64.1%) used less than half of the amount prescribed, and 256 patients (27.8%) did not use any opioids (179 [24.1%] who underwent orthopedic procedures and 77 [43.5%] who underwent urologic procedures).Conclusions and relevanceIn this quality improvement study of adult patients reporting use of opioids after common orthopedic and urologic surgical procedures through a text messaging system, the quantities of opioids prescribed and the quantity consumed differed. Patient-reported data collected through text messaging may support clinicians in tailoring prescriptions and guide shared decision-making to limit excess quantities of prescribed opioids.

Dataset Information

HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the phase 3 EPOCH 2 study.

Publications

HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the phase 3 EPOCH 2 study.

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