scholarly journals HTX-011 effectively reduces postoperative pain intensity and opioid use in the elderly

2021 ◽  
Author(s):  
Tina Yip ◽  
Jia Hu ◽  
Pamela S Hawn ◽  
Amy Yamamoto ◽  
Gary Oderda
Keyword(s):  
Clinical Trial ◽  
Postoperative Pain ◽  
Elderly Patients ◽  
Pain Intensity ◽  
Local Anesthetic ◽  
Extended Release ◽  
The Elderly ◽  
Opioid Consumption ◽  
Opioid Use ◽  
Clinical Trial Registration

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

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

Hernia ◽  
2019 ◽  
Vol 23 (6) ◽  
pp. 1071-1080 ◽  
Author(s):  
E. Viscusi ◽  
H. Minkowitz ◽  
P. Winkle ◽  
S. Ramamoorthy ◽  
J. Hu ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Pain Intensity ◽  
Local Anesthetic ◽  
Immediate Release ◽  
Opioid Consumption ◽  
Opioid Use ◽  
Phase 3 ◽  
Double Blind ◽  
Mesh Placement ◽  
Number Of Patients

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.

scholarly journals The Effect of Subcutaneous and Intraperitoneal Instillation of Local Anesthetics on Postoperative Pain after Laparoscopic Varicocelectomy: A Randomized Controlled Trial

Children ◽  
2021 ◽  
Vol 8 (11) ◽  
pp. 1051
Author(s):  
Zenon Pogorelić ◽  
Tea Gaberc ◽  
Miro Jukić ◽  
Goran Tintor ◽  
Ana Nevešćanin Biliškov ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Postoperative Pain ◽  
Pain Intensity ◽  
Randomized Clinical Trial ◽  
Local Anesthetic ◽  
Local Anesthetics ◽  
Control Group ◽  
Number Of Patients ◽  
Intraperitoneal Instillation ◽  
Time Point

Background: The main goal of the present randomized clinical trial was to investigate the effects of subcutaneous administration of two different local anesthetics at trocar incision sites at the abdominal wall in combination with intraoperative intraperitoneal instillation of local anesthetics, on the character of postoperative pain, in adolescents who underwent laparoscopic varicocelectomy. Methods: A total of 60 patients with a median age of 16 years, who received laparoscopic varicocele repair, were included in this randomized clinical trial. The patients were randomly assigned to three study groups receiving 2% lidocaine, 0.5% levobupivacaine, or the control group. The Visual Analogue Scale (VAS) was used by a blinded nurse at four different time points (2, 6, 12 and 24 h after the surgery) to measure pain intensity. Results: The significant effect of time on the pain intensity (p = 0.001) was found. Additionally, the interaction between time and different local analgesics (p < 0.001) was observed. In patients in whom 0.5% levobupivacaine has been used, significantly lower VAS pain scores were recorded at each time point assessed, in comparison with the patients who received 2% lidocaine or the patients from the control group in whom no local anesthetic was applied (p < 0.001). Furthermore, in patients in whom 2% lidocaine was administrated, significantly lower pain levels according to VAS were reported than in those from the control group, except for the time point at 24 h after surgery when pain levels were comparable. Concerning the postoperative pain control, the number of patients who requested oral analgesics postoperatively was significantly lower in the group of patients in whom local anesthetic was administrated intraoperatively (2% lidocaine – n = 4, 20%; 0.5% levobupivacaine – n = 1, 5%) compared to the patients who did not receive any local anesthetic during the surgery (n = 13; 65%) (p < 0.001). Conclusion: A significant reduction in postoperative pain intensity and analgesics consumption in patients undergoing laparoscopic varicocelectomy who received intraoperative local anesthetic was observed. The best effect on postoperative pain intensity, according to the VAS score, was achieved by 0.5% levobupivacaine.

scholarly journals HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: phase III results from the randomized EPOCH 1 study

2019 ◽  
Vol 44 (7) ◽  
pp. 700-706 ◽  
Author(s):  
Eugene Viscusi ◽  
Joseph S Gimbel ◽  
Richard A Pollack ◽  
Jia Hu ◽  
Gwo-Chin Lee
Keyword(s):  
Postoperative Pain ◽  
Local Anesthetic ◽  
Immediate Release ◽  
Opioid Consumption ◽  
Phase Iii ◽  
Opioid Use ◽  
Double Blind ◽  
Registration Number ◽  
Secondary Endpoints ◽  
Phase Iii Study

Background and objectivesThere is a need for local anesthetics that provide consistent analgesia through 72 hours after surgery. This study evaluates the use of HTX-011 (bupivacaine and meloxicam in Biochronomerpolymer technology), an extended-release, dual-acting local anesthetic, in reducing both postoperative pain over 72 hours and postoperative opioid use when compared with bupivacaine hydrochloride (HCl) and saline placebo. Inclusion of low-dose meloxicam in HTX-011 is designed to reduce local inflammation caused by surgery, potentiating the analgesic effect of bupivacaine. Previously, significant synergy has been observed with bupivacaine and meloxicam with both given locally together.MethodsEPOCH 1 was a randomized, double-blind, placebo-controlled and active-controlled phase III study in subjects undergoing a primary unilateral, distal, first metatarsal bunionectomy in which subjects received either a single intraoperative dose of HTX-011, immediate-release bupivacaine HCl or saline placebo.ResultsA total of 412 subjects were dosed. The results for the primary and all four key secondary endpoints were statistically significant in favor of HTX-011. HTX-011 demonstrated superior, sustained pain reduction through 72 hours, significantly reduced opioid consumption and resulted in significantly more opioid-free subjects compared with saline placebo and bupivacaine HCl. Safety was similar across groups with fewer opioid-related adverse events observed in the HTX-011 group.ConclusionsHTX-011 demonstrated significant reduction in postoperative pain through 72 hours with significant reduction in opioid consumption and a significant increase in the proportion of opioid-free subjects compared with saline placebo and the most widely used local anesthetic, bupivacaine HCl.Trial registration numberNCT03295721.

scholarly journals Opioid-Free Recovery from Bunionectomy with HTX-011, a Dual-Acting Local Anesthetic Combining Bupivacaine and Meloxicam, as the Foundation of Non-Opioid Multimodal Analgesia

2021 ◽  
Author(s):  
Richard Pollak ◽  
Danlin Cai ◽  
Tong J. Gan
Keyword(s):  
Postoperative Pain ◽  
Pain Intensity ◽  
Local Anesthetic ◽  
Rescue Medication ◽  
Rating Scale ◽  
Recovery Period ◽  
Multimodal Analgesia ◽  
Numeric Rating Scale ◽  
Opioid Use ◽  
Pain Scores

Background: There is a need for postoperative pain control that minimizes/eliminates opioid use during the first 72 hours following surgery, when pain is most severe. HTX-011 is an extended-release, dual-acting local anesthetic that demonstrated superior 72-hour analgesia over standard of care bupivacaine hydrochloride (HCl) and saline placebo in a phase 3 bunionectomy study (EPOCH-1). Having shown HTX-011 monotherapy is superior to bupivacaine HCl in reducing postoperative pain intensity and opioid use, this follow-on study evaluated the safety and efficacy of HTX-011 as the foundation of a multimodal analgesia (MMA) regimen using over-the-counter medications recommended by practice guidelines for pain management. Methods: Following regional anesthesia administered as a lidocaine block, patients underwent unilateral bunionectomy with osteotomy and internal fixation. Prior to closure, HTX-011 (up to 60 mg bupivacaine/1.8 mg meloxicam) was applied without a needle. Patients received scheduled postoperative MMA alternating ibuprofen (600 mg) and acetaminophen (1 g) every 3 hours for 72 hours. Efficacy was assessed based on pain intensity (numeric rating scale [NRS; 0-10]) and consumption of opioid rescue medication (intravenous morphine milligram equivalents [MME]). Adverse event and vital sign monitoring, plus laboratory and wound healing assessments, were used to determine safety. Results: Over the 72-hour assessment period following bunionectomy, mean pain scores were mild in severity (NRS &lt;4) and 22/31 patients (71%) experienced no severe pain (NRS {greater than or equal to}7) with HTX-011 as the foundation of scheduled, non-opioid MMA. Patients consumed an average of 1.61 MME total, with 24/31 (77%) requiring no opioid rescue medication (opioid-free). HTX-011 was well-tolerated and demonstrated no safety concerns with the inclusion of postoperative MMA. Conclusions: HTX-011 as the foundation of an MMA regimen including scheduled ibuprofen and acetaminophen maintained mean postoperative pain scores in the mild range and enabled opioid-free recovery for 77% of bunionectomy patients through the 28-day recovery period.

scholarly journals Intra-articular magnesium to alleviate postoperative pain after arthroscopic knee surgery: a meta-analysis of randomized controlled trials

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Lijun Shi ◽  
Haiyun Zhu ◽  
Jinhui Ma ◽  
Li-Li Shi ◽  
Fuqiang Gao ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Randomized Controlled Trials ◽  
Pain Intensity ◽  
Opioid Consumption ◽  
Knee Surgery ◽  
Cochrane Library ◽  
Controlled Trials ◽  
Arthroscopic Knee Surgery ◽  
Randomized Controlled ◽  
Arthroscopic Knee

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.

589 Methadone in Procedural Care for Burn Injuries of 20–30% Total Burn Surface Area: A Retrospective Chart Review

2021 ◽  
Vol 42 (Supplement_1) ◽  
pp. S146-S146
Author(s):  
Loryn Taylor ◽  
Kimberly Maynell ◽  
Thanh Tran ◽  
David J Smith
Keyword(s):  
Physical Therapy ◽  
Postoperative Pain ◽  
Pain Intensity ◽  
Surface Area ◽  
Chart Review ◽  
Retrospective Chart Review ◽  
Opioid Consumption ◽  
Burn Injuries ◽  
Methadone Group ◽  
Significant Difference

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.

scholarly journals Analgesic Effect of Dexamethasone after Arthroscopic Knee Surgery: A Randomized Controlled Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-6
Author(s):  
Jairo Moyano ◽  
Maria García ◽  
Maria Caicedo
Keyword(s):  
Postoperative Pain ◽  
Pain Intensity ◽  
Knee Surgery ◽  
Controlled Study ◽  
Opioid Use ◽  
Arthroscopic Knee Surgery ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Intraoperative Period ◽  
Arthroscopic Knee

Background.Dexamethasone is sometimes used as a coanalgesic because of its anti-inflammatory properties.Objective. To evaluate opioid use, postoperative pain intensity, and side effects after a single dose of dexamethasone in patients undergoing arthroscopic knee surgery.Methods. In this randomized controlled study patients were randomized to receive either 10 mg of intravenous dexamethasone (DM group) or 0.9% normal saline (NS group) during the intraoperative period. Primary outcomes were pain intensity and total morphine and codeine use after surgery.Results. Seventy-eight patients were included in the study. The DM group showed statistically significant higher pain intensity at the fourth postoperative hour (DM: 3.96/10, standard deviation [SD] 0.54; NS: 2.46/10, SD 0.45;p=0.036). No statistically significant difference in total opioid use (morphine plus codeine) was identified with 15.9 (SD 1.97) codeine tablets used in DM group and 20 (SD 2.14) in NS group (p=0.25).Discussion. Pain intensity tended to decrease in both groups suggesting morphine as the main source of analgesia.Conclusions. Intravenous dexamethasone during the intraoperative period has no clinical impact on postoperative pain intensity during the first 48 h after arthroscopic knee surgery. This trial is registered withR000020892.

Psychological interventions to reduce postoperative pain and opioid consumption: a narrative review of literature

2021 ◽  
pp. rapm-2020-102434
Author(s):  
Kevin Gorsky ◽  
Nick D Black ◽  
Ayan Niazi ◽  
Aparna Saripella ◽  
Marina Englesakis ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Postoperative Period ◽  
Opioid Consumption ◽  
Psychological Interventions ◽  
Cochrane Central Register ◽  
Relaxation Techniques ◽  
Behavioral Modification ◽  
Opioid Use ◽  
Pain Scores ◽  
Study Results

BackgroundEvidence suggests that over half of patients undergoing surgical procedures suffer from poorly controlled postoperative pain. In the context of an opioid epidemic, novel strategies for ameliorating postoperative pain and reducing opioid consumption are essential. Psychological interventions defined as strategies targeted towards reducing stress, anxiety, negative emotions and depression via education, therapy, behavioral modification and relaxation techniques are an emerging approach towards these endpoints.ObjectiveThis review explores the efficacy of psychological interventions for reducing postoperative pain and opioid use in the acute postoperative period.Evidence reviewAn extensive literature search was conducted in MEDLINE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Medline In-Process/ePubs, Embase, Ovid Emcare Nursing, and PsycINFO, Web of Science (Clarivate), PubMed-NOT-Medline (NLM), CINAHL and ERIC, and two trials registries, ClinicalTrials.Gov (NIH) and WHO ICTRP. Included studies were limited to those investigating adult human subjects, and those published in English.FindingsThree distinct forms of psychological interventions were identified: relaxation, psychoeducation and behavioral modification therapy. Study results showed a reduction in both postoperative opioid use and pain scores (n=5), reduction in postoperative opioid use (n=3), reduction in postoperative pain (n=5), no significant reduction in pain or opioid use (n=7), increase in postoperative opioid use (n=1) and an increase in postoperative pain (n=1).ConclusionSome preoperative psychological interventions can reduce pain scores and opioid consumption in the acute postoperative period; however, there is a clear need to strengthen the evidence for these interventions. The optimal technique, strategies, timing and interface requires further investigation.

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