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 <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 Pain Intensity on the First Day after Surgery

2013 ◽  
Vol 118 (4) ◽  
pp. 934-944 ◽  
Author(s):  
Hans J. Gerbershagen ◽  
Sanjay Aduckathil ◽  
Albert J. M. van Wijck ◽  
Linda M. Peelen ◽  
Cor J. Kalkman ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Pain Intensity ◽  
Surgical Procedures ◽  
Severe Pain ◽  
Rating Scale ◽  
Pain Treatment ◽  
Numeric Rating Scale ◽  
Treatment Needs ◽  
Pain Scores ◽  
Numeric Rating

Abstract Background: Severe pain after surgery remains a major problem, occurring in 20–40% of patients. Despite numerous published studies, the degree of pain following many types of surgery in everyday clinical practice is unknown. To improve postoperative pain therapy and develop procedure-specific, optimized pain-treatment protocols, types of surgery that may result in severe postoperative pain in everyday practice must first be identified. Methods: This study considered 115,775 patients from 578 surgical wards in 105 German hospitals. A total of 70,764 patients met the inclusion criteria. On the first postoperative day, patients were asked to rate their worst pain intensity since surgery (numeric rating scale, 0–10). All surgical procedures were assigned to 529 well-defined groups. When a group contained fewer than 20 patients, the data were excluded from analysis. Finally, 50,523 patients from 179 surgical groups were compared. Results: The 40 procedures with the highest pain scores (median numeric rating scale, 6–7) included 22 orthopedic/trauma procedures on the extremities. Patients reported high pain scores after many “minor” surgical procedures, including appendectomy, cholecystectomy, hemorrhoidectomy, and tonsillectomy, which ranked among the 25 procedures with highest pain intensities. A number of “major” abdominal surgeries resulted in comparatively low pain scores, often because of sufficient epidural analgesia. Conclusions: Several common minor- to medium-level surgical procedures, including some with laparoscopic approaches, resulted in unexpectedly high levels of postoperative pain. To reduce the number of patients suffering from severe pain, patients undergoing so-called minor surgery should be monitored more closely, and postsurgical pain treatment needs to comply with existing procedure-specific pain-treatment recommendations.

scholarly journals Multimodal Analgesia in Perioperative Settings: Improvement Perspectives / Multimodāla Analgēzija Perioperatīvajā Periodā: Uzlabošanas Iespējas

2014 ◽  
Vol 68 (5-6) ◽  
pp. 222-227
Author(s):  
Iveta Golubovska ◽  
Aleksejs Miščuks ◽  
Ēriks Rudzītis
Keyword(s):  
Pain Management ◽  
Lower Extremity ◽  
Pain Intensity ◽  
Severe Pain ◽  
Rating Scale ◽  
Multimodal Analgesia ◽  
Numeric Rating Scale ◽  
Plexus Brachialis ◽  
Single Shot ◽  
Maximum Pain

Abstract The aim of this study was to evaluate the intensity of pain in orthopaedic hospital patients and to identify unsatisfactory pain management and possibilities for improvements in the future. Data collection included Numeric Rating Scale (NRS) scores, which characterised the intensity of pain. Maximum pain on the day of surgery, mean pain on the day of surgery (D0), and mean pain on first (D1) and second (D2) postoperative days were documented. The pain of an intensity from 0 to 3 was defined as mild pain, 4 to 6 as moderate pain, and 6 to 10 as severe pain. Maximum severe pain intensity on the day of surgery was experienced by 20.5% of patients, moderate by 45.8%, and mild by 33.6%. The reported mean pain intensity according to type of surgery was as follows: hip replacement- 2.79 ± 1.6 (D0), 2.09 ± 1.4 (D1), and 1.35 ± 1.2 (D2); knee replacement - 3.39 ± 1.7 (D0), 2.98 ± (D1), 1.82 ± 1.36, and (D2); upper extremity surgery - 3.59 ± 1.9 (D0), 3.4 ± 1.7 (D1), and 2.1 ± 1.5 (D2); lower extremity surgery - 4.1 ± 2.1 (D0), 3.49 ± 1.42 (D1), and 2.58 ± 1.4 (D2); spine surgery - 3.31 ± 1.58 (D0), 2.88 ± 1.96 (D1), and 1.83 ± 1.74 (D2). Patients in the lower extremity group experienced unacceptable mean pain. The maximum pain intensity on day of surgery was experienced by patients after single-shot plexus brachialis block anaesthesia (5.24 ± 2.4). Well-designed multimodal analgesia with special attention to single shot techniques may improve pain management and functional outcomes after orthopaedic surgery.

Comparison of the Effectiveness between 5% Eutectic Mixture of Local Anesthetic Cream and Ethyl Chloride Spray Applied on the Skin Prior to Intravenous Cannulation

2021 ◽  
Vol 104 (1) ◽  
pp. 73-78
Keyword(s):  
Local Anesthetic ◽  
Pain Perception ◽  
Rating Scale ◽  
Eutectic Mixture ◽  
Numeric Rating Scale ◽  
Ethyl Chloride ◽  
Endoscopic Procedure ◽  
Pain Scores ◽  
Study Participants ◽  
Numeric Rating

Background: Since the patients scheduled for an endoscopic procedure had been unhappy with pain during intravenous cannulation. Objective: To compare the effectiveness between 5% eutectic mixture of local anesthetic cream and ethyl chloride spray applied on the skin prior to the procedure. Materials and Methods: One hundred eighty-six patients were randomized equally into three groups, A: 5% eutectic mixture of local anesthetic cream, B: ethyl chloride spray, and C: placebo. Then a nurse used a 22-gauge (22G) needle catheter to administer a cannula. Five minutes after the intravenous cannulation, a co-researcher assessed the patient’s pain perception and satisfaction as well as the nurse’s difficulty in performance by means of a numeric rating scale. Results: One hundred seventy-six patients completed the present study. Participants having the anesthetic cream and spray application as well as the placebo expressed their pain scores as 1.7±1.3, 1.6±1.2, and 2.2±1.3, respectively. Therefore, patients applied with local anesthetics had significantly less pain perception than those with the placebo (p=0.039); however, scores were not different between the anesthetic cream and the spray groups. Conclusion: Patients scheduled for an endoscopic procedure did not showed significant pain relief with either the 5% eutectic mixture of local anesthetic cream or the ethyl chloride spray. Keywords: 5% eutectic mixture of local anesthetic cream, Ethyl chloride spray, Endoscopic surgery, Intravenous cannulation, Pain

Procedure-specific Risk Factor Analysis for the Development of Severe Postoperative Pain

2014 ◽  
Vol 120 (5) ◽  
pp. 1237-1245 ◽  
Author(s):  
Hans J. Gerbershagen ◽  
Esther Pogatzki-Zahn ◽  
Sanjay Aduckathil ◽  
Linda M. Peelen ◽  
Teus H. Kappen ◽  
...  
Keyword(s):  
Risk Factors ◽  
Chronic Pain ◽  
Postoperative Pain ◽  
Pain Intensity ◽  
Surgical Procedures ◽  
Rating Scale ◽  
Random Effect ◽  
Numeric Rating Scale ◽  
Younger Age ◽  
Severe Postoperative Pain

Abstract Background: Many studies have analyzed risk factors for the development of severe postoperative pain with contradictory results. To date, the association of risk factors with postoperative pain intensity among different surgical procedures has not been studied and compared. Methods: The authors selected precisely defined surgical groups (at least 150 patients each) from prospectively collected perioperative data from 105 German hospitals (2004–2010). The association of age, sex, and preoperative chronic pain intensity with worst postoperative pain intensity was studied with multiple linear and logistic regression analyses. Pooled data of the selected surgeries were studied with random-effect analysis. Results: Thirty surgical procedures with a total number of 22,963 patients were compared. In each surgical procedure, preoperative chronic pain intensity and younger age were associated with higher postoperative pain intensity. A linear decline of postoperative pain with age was found. Females reported more severe pain in 21 of 23 surgeries. Analysis of pooled surgical groups indicated that postoperative pain decreased by 0.28 points (95% CI, 0.26 to 0.31) on the numeric rating scale (0 to 10) per decade age increase and postoperative pain increased by 0.14 points (95% CI, 0.13 to 0.15) for each higher score on the preoperative chronic pain scale. Females reported 0.29 points (95% CI, 0.22 to 0.37) higher pain intensity. Conclusions: Independent of the type and extent of surgery, preoperative chronic pain and younger age were associated with higher postoperative pain. Females consistently reported slightly higher pain scores regardless of the type of surgery. The clinical significance of this small sex difference has to be analyzed in future studies.

The influence of chief complaint on opioid use in the emergency department

2006 ◽  
Vol 2 (4) ◽  
pp. 228 ◽  
Author(s):  
Kathleen Puntillo, RN, DNSc, FAAN ◽  
Martha Neighbor, MD ◽  
Garrett K. Chan, APRN, BC, PhD ◽  
Roxanne Garbez, RN, MS, ACNP
Keyword(s):  
Emergency Department ◽  
Rating Scale ◽  
Patient Discharge ◽  
Numeric Rating Scale ◽  
Opioid Use ◽  
Pain Scores ◽  
Patient Pain ◽  
Nurses And Physicians ◽  
Time Of Admission ◽  
Numeric Rating

The aim of this study was to explore factors influencing emergency department (ED) clinicians’ use of opioids in treating selected patients. Patients who either received or did not receive opioids in the ED, as well as their nurses and physicians, were interviewed before patient discharge. We found that the decrease in patients’ mean (SD) pain intensity from the time of admission to the ED (7.3 ± 2.4 on a 0 to 10 numeric rating scale) to discharge (5.0 ± 2.9) was statistically significant (t93 = 8.4, p < 0.001, 95 percent CI = 1.7, 2.8) for all groups except those with trauma-related pain. The factor that most frequently led physicians of patients with abdominal pain and nurses in general to administer no opioids was that the patient was “not in that much pain.” However, the patients in question had self-reported pain scores that indicated moderate pain. Our findings lead us to conclude that clinicians inaccurately infer severity of patient pain. This in turn can influence the prescription of opioids and the patient’s decrease in pain.

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 Postoperative Drip-Infusion of Remifentanil Reduces Postoperative Pain—A Retrospective Observative Study

2021 ◽  
Vol 18 (17) ◽  
pp. 9225
Author(s):  
Yi-Hsuan Huang ◽  
Meei-Shyuan Lee ◽  
Yao-Tsung Lin ◽  
Nian-Cih Huang ◽  
Jing Kao ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Adverse Effects ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Intravenous Anesthesia ◽  
Anesthetic Care ◽  
Drip Infusion ◽  
Pain Scores ◽  
Unpleasant Experience ◽  
Numeric Rating

Development of remifentanil-induced hyperalgesia (RIH) postoperatively is an unpleasant experience that requires further treatment. This study assessed the effects of gradual withdrawal combined with drip infusion of remifentanil on postoperative pain and the requirement for rescue analgesics. A total of 559 patients receiving total intravenous anesthesia with propofol and remifentanil were enrolled. All patients either underwent gradual withdrawal of remifentanil (GWR) or gradual withdrawal combined with drip infusion (GWDR) with a dose of 1 mcg·kg−1 for 30 min after extubation. The numeric rating scale (NRS) and the requirement of rescue analgesics were assessed. The requirement for rescue analgesics was significantly lower in the GWDR group than in the GWR group (13.2% vs. 35.7%; p < 0.001). At the post-anesthetic care unit (PACU), patients in the GWDR group had a lower NRS pain score (p < 0.001). In addition, in the postoperative 2nd hour, patients in the GWDR group had a significantly lower NRS than the GWR group (beta, −0.31; p = 0.003). No remifentanil-related adverse effects were observed. We found that gradual withdrawal combined with drip infusion of remifentanil required less rescue analgesics and reduced pain scores. The new way of remifentanil administration may be effective to prevent RIH.

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 Characterization of  self-anticipated surgical pain prior to general anesthesia - a prospective observational study

2021 ◽  
Author(s):  
Wei-Shu Chang ◽  
Yi-Ting Hsieh ◽  
Moa-Chu Chen ◽  
Shu-Ching Chang ◽  
Tzu-Shan Chen ◽  
...  
Keyword(s):  
Pain Management ◽  
Postoperative Pain ◽  
Observational Study ◽  
General Anesthesia ◽  
Pain Intensity ◽  
Pain Score ◽  
Prospective Observational Study ◽  
Rating Scale ◽  
Perioperative Period ◽  
Pain Scores

Abstract Background: Current postoperative pain management principles are primarily based on the type and extent of surgical interventions. This clinical study measured patient’s self-anticipated pain score before surgery and compared the scores with the pain levels and analgesic requirements after surgery.Methods: This prospective observational study recruited consecutive patients who received general anesthesia for elective surgeries in E-Da Hospital (Taiwan) between June and August 2018. Patients were asked to subjectively rate their highest anticipated pain level (numerical rating scale, NRS 0-10) for their scheduled surgical intervention during their preoperative anesthesia assessment. After the operation, the actual pain intensity (NRS 0-10) experienced by the patient in the post-anesthesia care unit (PACU) and the total dose of opioids administered during the perioperative period were recorded. Pain scores ³4 on the NRS were regarded as being unacceptable levels of anticipated or postoperative pain.Results: A total of 857 patients were included in the study. The final database included 49.2% males, and 73.7% of them have had previous operations. The mean anticipated pain score was 4.9±2.5 and 72.2% of the patients reported an anticipated NRS ³4 before their operations. Females anticipated significantly higher overall pain intensities than male patients (adjusted odds ratio 1.695, 95% confidence interval 1.252-2.295; P=0.001). Patients over 40 years of age reported significantly lower overall anticipated NRS scores (4.78±2.49 vs 5.36±2.50; P=0.003). Patients scheduled to receive more invasive surgical procedures were more likely to anticipate high pain intensity in the preoperative period (P<0.001). Higher anticipated pain scores (preoperative NRS³4) were associated with higher actual postoperative pain levels (P=0.032) in the PACU and higher total equivalent opioid use (P=0.001) for acute pain management during the perioperative period.Conclusion: This observational study found that females, younger patients (£40 years), and patients scheduled for more invasive surgeries anticipate significantly higher surgery-related pain. Therefore, appropriate preoperative counseling for analgesic control and management of exaggerated pain expectation in these patients are necessary to improve the quality of anesthesia delivered and patient’s satisfaction.

scholarly journals Prevention of Acute Postoperative Pain in Breast Cancer: A Comparison between Opioids versus Ketamine in the Intraoperatory Analgesia

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Mirian López ◽  
María Luz Padilla ◽  
Blas García ◽  
Javier Orozco ◽  
Ana María Rodilla
Keyword(s):  
Breast Cancer ◽  
Postoperative Pain ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Cancer Surgery ◽  
Breast Cancer Surgery ◽  
Opioid Use ◽  
Acute Postoperative Pain ◽  
Systemic Side Effects ◽  
Waking Up

Background. Acute postoperative pain (APP) has a high incidence in breast surgery, and opioids are the most commonly used drugs for its management; however, they are not free from systemic side effects, which may increase comorbidity. In the past few years, opioid-free anaesthesia has been favoured with promising results. Methods. We conducted a descriptive study including 71 patients who underwent breast cancer surgery. The opioid group (n = 41) received fentanyl for induction, remifentanil for maintenance, and rescue morphine before waking up, whereas the ketamine group (n = 30) received a ketamine bolus for induction followed by continuous ketamine infusion during surgery. Later, the presence and intensity of pain were registered, using the Numeric Rating Scale (NRS 1–10) for pain, at different times in the recovery room, at 24 hours and at 3 months. Results. Administration of ketamine is more effective than opioid use for APP prevention in breast cancer surgery because the ketamine group presented with less pain than the opioid group ( p  < 0.05) at all measured times. When there was pain, patients in the ketamine group gave a lower score to its intensity ( p  < 0.05). Conclusions. Ketamine could reduce the incidence of APP in breast cancer surgery, compared to opioids.

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