HTX-011, a Proprietary, Extended-Release Combination of Bupivacaine and Meloxicam, Reduces Acute Postoperative Pain Intensity and Opioid Consumption after Bunionectomy: Results From an Interim Analysis

2017 ◽  
Vol 225 (4) ◽  
pp. e37
Author(s):  
Eugene R. Viscusi ◽  
Oscare DeLeon-Casasola ◽  
T.J. Gan ◽  
Erol Onel ◽  
Guy Boccia ◽  
...  
2021 ◽  
Author(s):  
Tina Yip ◽  
Jia Hu ◽  
Pamela S Hawn ◽  
Amy Yamamoto ◽  
Gary Oderda

Aim: HTX-011 (ZYNRELEF™) is an extended-release, dual-acting local anesthetic containing bupivacaine and meloxicam. In bunionectomy and herniorrhaphy studies, HTX-011 resulted in less postoperative pain and less opioid consumption versus bupivacaine HCl. Here we evaluate HTX-011 in patients aged ≥65 years. Materials & methods: Patients received placebo, bupivacaine HCl or HTX-011 following surgery. End points included pain intensity, total opioid consumption, opioid-free patients and safety. Results: HTX-011-treated patients reported lower postoperative pain through 72 h versus bupivacaine HCl and placebo. Elderly patients administered HTX-011 used fewer opioids versus bupivacaine HCl, and a greater proportion remained opioid-free through 72 h. HTX-011 was well tolerated with a safety profile similar to bupivacaine HCl and placebo. Conclusion: HTX-011 maintained effectiveness and was well tolerated in elderly patients. Clinical Trial Registration: NCT03295721 and NCT03237481


2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Lijun Shi ◽  
Haiyun Zhu ◽  
Jinhui Ma ◽  
Li-Li Shi ◽  
Fuqiang Gao ◽  
...  

Abstract Objective We aimed to evaluate the safety and efficacy of intra-articular (IA) magnesium (Mg) for postoperative pain relief after arthroscopic knee surgery. Methods We searched PubMed, Embase, Medline, Cochrane library, and Web of Science to identify randomized controlled trials that compared postoperative pain outcomes with or without IA Mg after knee arthroscopy. The primary outcomes were pain intensity at rest and with movement at different postoperative time points and cumulative opioid consumption within 24 h after surgery. Secondary outcomes included the time to first analgesic request and side effects. Results In total, 11 studies involving 677 participants met the eligibility criteria. Pain scores at rest and with movement 2, 4, 12, and 24 h after surgery were significantly lower, doses of supplementary opioid consumption were smaller, and the time to first analgesic requirement was longer in the IA Mg group compared with the control group. No significant difference was detected regarding adverse reactions between the groups. Conclusions Intra-articular magnesium is an effective and safe coadjuvant treatment for relieving postoperative pain intensity after arthroscopic knee surgery. Protocol registration at PROSPERO: CRD42020156403.


2021 ◽  
Vol 42 (Supplement_1) ◽  
pp. S146-S146
Author(s):  
Loryn Taylor ◽  
Kimberly Maynell ◽  
Thanh Tran ◽  
David J Smith

Abstract Introduction Prolonged opioid usage remains a concern in pain management in procedural care. Recent evidence also suggests that a considerable number of patients who were prescribed opioids struggle with transitioning to non-opioid pain medications. As a continuous effort to reduce opioid consumption following burn surgical procedures, our institution recently evaluated methadone administration for burn procedural care in patients with 20–30% total burn surface area (TBSA) requiring excision and grafting. Methods After IRB approval, we performed a retrospective chart review of patients who underwent excision and grafting procedure for 20–30% TBSA burn injuries between January 1, 2019 and June 30, 2020. The following data was evaluated: postoperative opioid consumption, postoperative pain intensity (rated as “No Pain” [NRS=0], “Minor Pain” [NRS 1 to 3], “Moderate Pain” [NRS 4 to 6], “Severe Pain” [NRS 7 to 10]), time to physical therapy and time to hospital discharge. Data was analyzed using chi square/Fisher exact test for categorical variables and t-test/Wilcoxon rank sum test for continuous variables. Results Our preliminary data included 12 patients who met inclusion criteria, of which two patients received methadone administration. Our patient sample consisted of average age of 43 years, 75% male, and 24% TBSA (92% were flame burns). Patients in both methadone and non-methadone groups had no significant differences in medical histories and TBSA (23% TBSA in methadone, 25% TBSA in non-methadone). There was no significant difference in reported preoperative pain intensity between the two groups, rating moderate to severe. Postoperative pain intensity remained the same, rating moderate to severe and controlled with fentanyl, oxycodone, morphine and non-opioid analgesics. While there was no difference in postoperative fentanyl, opioid and non-opioid analgesic consumptions between the two groups, morphine consumption was significantly lower in the methadone group compared to non-methadone group (2±2 mg vs 51±54 mg, respectively, p=0.02). There was no significant difference between average time from surgery to first physical therapy session and time to hospital discharge (about 21 days after surgery) between the two groups. Conclusions This evaluation shows a potential trend in reduction of inpatient postoperative opioid consumption with the conjunctive administration of methadone, although a bigger sample size is needed for further assessment.


2021 ◽  
Vol 132 (5) ◽  
pp. 1465-1474
Author(s):  
Raheleh Baharloo ◽  
Jose C. Principe ◽  
Roger B. Fillingim ◽  
Margaret R. Wallace ◽  
Baiming Zou ◽  
...  

2019 ◽  
Vol 129 (6) ◽  
pp. 1723-1732 ◽  
Author(s):  
Felipe C. Machado ◽  
Joaquim E. Vieira ◽  
Flávia A. de Orange ◽  
Hazem A. Ashmawi

2010 ◽  
Vol 1 (3) ◽  
pp. 172-172
Author(s):  
Nina Solheim ◽  
Bente Halvorsen ◽  
Leiv Arne Rosseland ◽  
Audun Stubhaug

Abstract Postsurgical inflammation leads to sensitisation of “sleeping” nociceptors, which enhance pain perception and induce hyperalgesia. Prostaglandin E2 plays a central role in this process. Synovial microdialysis technique allows analyses of biological markers of local inflammation simultaneous with a close follow up of the patient’s pain experience. Tissue injury (or surgery) initiates liberation of inflammatory mediators and hyperalgesic substances. This project is translational and aims at exploring the relationship between perceived acute postoperative pain and inflammation. Microdialysis of synovial tissue and pain score after arthroscopy is of special interest to study since the natural pain course and the local inflammation can be observed in patients with no analgesic therapy. Methods This is a clinical observational study of local inflammatory mediators and perceived pain in patients undergoing knee arthroscopy in general anesthesia with propofol, remifentanil and fentanyl. Microdialysis of the synovial membrane was performed in all patients every 20 min for 140 min postoperatively (seven samples). At the same intervals PGE2 was measured and correlated with patients report of pain intensity on a 0–100mm visual analogue scale (VAS). Results Five patients (1 female, 4 male) who did not receive any non-steroidal antiinflammatory drugs or paracetamol were included. The pain intensity was 1–34mmVAS and the PGE2 levels were from 293 pg/ml to 5818 pg/ml. Maximum pain score (mean 23 and SD 12mm VAS) and PGE2 levels (mean 2026 pg/ml and SD 1380 pg/ml) occurred about 40 min after surgery. Correlation analysis shows a significant correlation (R = 0.48, p = 0.004). Conclusion This pilot study indicates a positive correlation between postoperatively perceived pain and local PGE2 concentration.


2020 ◽  
Vol 15 (2) ◽  
pp. 157-166
Author(s):  
Ji Youn Ju ◽  
Kye-Min Kim ◽  
Sangseok Lee

Background: Alpha-2 agonists have sedative, analgesic, and opioid-sparing effects. Moreover, intraoperative or postoperative systemic administration of alpha-2 adrenergic agonists is known to reduce postoperative pain and opioid consumption. This meta-analysis investigated whether preoperative administration of alpha-2 agonists can affect postoperative pain and opioid consumption.Methods: We searched the MEDLINE, EMBASE, Cochrane Library (CENTRAL), KoreaMed, and KMbase databases through March 2019 to identify relevant randomized controlled trials (RCTs) on the effect of preoperative systemic administration of alpha-2 agonists on postoperative pain and opioid consumption. We conducted a meta-analysis according to the Cochrane Collaboration guidelines. Standardized mean differences (SMDs) of postoperative pain intensity or dose of opioid consumption in the alpha-2 agonist group were extracted and combined using a random-effect model and were compared to those of the control group.Results: Eleven RCTs involving 748 participants were included in this meta-analysis. Preoperative administration of systemic alpha-2 agonists significantly reduced cumulative opioid consumption up to 6 h (SMD, –0.52; 95% confidence interval [–0.90 to –0.14]) and 24 h (SMD, –0.68 [–1.27 to –0.09]) after surgery. Moreover, preoperative administration of alpha-2 agonists significantly reduced postoperative pain intensity at 6 h (SMD, –0.50 [–0.78 to –0.21]) and 24 h (SMD, –0.44 [–0.86 to –0.03]).Conclusions: In this meta-analysis, high degree of heterogeneity limits the preoperative administration of alpha-2 agonists in reducing postoperative opioid consumption and pain intensity. Future powered large RCTs are required to increase the certainty of evidence on the effect in reducing postoperative opioid consumption and pain intensity.


2016 ◽  
Vol 18 (4) ◽  
pp. 1013-1022 ◽  
Author(s):  
Rasmus V Juul ◽  
Katrine R Knøsgaard ◽  
Anne E Olesen ◽  
Katja V Pedersen ◽  
Mads Kreilgaard ◽  
...  

Hernia ◽  
2019 ◽  
Vol 23 (6) ◽  
pp. 1071-1080 ◽  
Author(s):  
E. Viscusi ◽  
H. Minkowitz ◽  
P. Winkle ◽  
S. Ramamoorthy ◽  
J. Hu ◽  
...  

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 < 0.001) and by 21% versus bupivacaine HCl (p < 0.001) with significant reductions in the number of patients experiencing severe pain. Opioid consumption over 72 h was reduced by 38% versus placebo (p < 0.001) and 25% versus bupivacaine HCl (p = 0.024). Overall, 51% of HTX-011 subjects were opioid-free through 72 h (versus 22% for placebo [p < 0.001] and 40% for bupivacaine HCl [p = 0.049]). HTX-011 was generally well-tolerated with fewer opioid-related adverse events reported compared to the bupivacaine HCl and placebo and no evidence of local anesthetic systemic toxicity. Conclusions HTX-011 demonstrated significant improvement in postoperative pain control and a clinically meaningful reduction in opioid consumption when compared to the most widely used local anesthetic, bupivacaine HCl.


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