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Comparing efficacy and safety between Naldebain® and intravenous patient-controlled analgesia with fentanyl for pain management post-laparotomy: study protocol for a randomized controlled, non-inferior trial.

ABSTRACT: BACKGROUND:A long-acting prodrug of nalbuphine, nalbuphine sebacate, has been developed for meeting the unmet medical need of long-acting analgesics. Naldebain® (nalbuphine sebacate) has been developed as a new premedication for postoperative pain management. The primary objective of this study is to determine the efficacy and safety of a single dose of intramuscular Naldebain® in patients scheduled to undergo elective laparotomy. METHODS/DESIGN:A total of 110 patients will be recruited and randomized into two treatment groups. Group 1 receives a single dose of Naldebain® intramuscularly 24?±?12?h prior to surgery. Group 2 receives intravenous patient-controlled analgesia (PCA) with fentanyl through 48?h postsurgery. Both groups will have follow-up observations until the final visit (day of discharge, day 6-30). The primary efficacy endpoint is to assess time-specific pain intensity calculated as the area under the curve (AUC) of a visual analog scale at individual time points and by using total AUC. Safety endpoints-including incidence of treatment, emergent adverse events, and percentage of abnormality from baseline to final visit-in vital signs, laboratory tests, and injection site evaluations will also be analyzed. Statistical analyses will be performed on the data to compare the two groups. DISCUSSION:Post-laparotomy pain can have a harmful effect on patient recovery; therefore, a slow-release formulation that can cover at least 7?days of analgesic effect is required. This study will demonstrate whether a single use of Naldebain® is not less efficacious than PCA with fentanyl for pain management as a non-inferior trial. TRIAL REGISTRATION:NCT03296488 .

SUBMITTER: Tsai HL

PROVIDER: S-EPMC6423831 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Comparing efficacy and safety between Naldebain<sup>®</sup> and intravenous patient-controlled analgesia with fentanyl for pain management post-laparotomy: study protocol for a randomized controlled, non-inferior trial.

Tsai Hsiang-Lin HL Chang Tsung-Kun TK Su Wei-Chih WC Yeh Yung-Sung YS Huang Ching-Wen CW Ma Cheng-Jen CJ Wang Jaw-Yuan JY

Trials 20190318 1

<h4>Background</h4>A long-acting prodrug of nalbuphine, nalbuphine sebacate, has been developed for meeting the unmet medical need of long-acting analgesics. Naldebain<sup>®</sup> (nalbuphine sebacate) has been developed as a new premedication for postoperative pain management. The primary objective of this study is to determine the efficacy and safety of a single dose of intramuscular Naldebain<sup>®</sup> in patients scheduled to undergo elective laparotomy.<h4>Methods/design</h4>A total of 11 ...[more]

PMID: 30885242

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Project description:Postoperative pain after major open gynecologic surgeries requires appropriate pain management.This study aimed at comparing perioperative patient controlled epidural analgesia (PCEA) and patient controlled intravenous analgesia (PCA) after gynecologic oncology surgeries.In this clinical trial study, 90 patients with American society of anesthesiologists (ASA) class I or II scheduled for gynecologic oncologic surgeries were randomly allocated to two groups (45 patients each group) to receive: patient-controlled epidural analgesia with bupivacaine and fentanyl (PCEA group), or patient controlled intravenous analgesia (IV PCA group) with fentanyl, pethidine and ondansetron. Postoperative pain was assessed over 48 hours using the visual analog scale (VAS). The frequency of rescue analgesia was recorded. Occurrence of any concomitant events such as nausea, vomiting, ileus, purities, sedation and respiratory complications were recorded postoperatively.There were no statistically significant differences in demographic data including; age, weight, ASA physical status, duration of surgery, intraoperative bleeding, and the amount of blood transfusion (P > 0.05), between the two studied groups. Severity of postoperative pain was not significantly different between the two groups (P > 0.05); however, after first patient mobilization, pain was significantly lower in the epidural group than the IV group (P < 0.001). There was no significant difference between the two groups regarding the incidence of complications such as nausea, vomiting, purities or ileus (P > 0.05). Nevertheless, the incidence and severity of sedation was significantly higher in the IV group (P < 0.001). Respiratory depression was higher in the IV group than the epidural group; this difference, however, was not significant (P = 0.11). In the epidural group, only 10 patients (22.2%) had mild and transient lower extremities parenthesis.Both intravenous and epidural analgesic techniques with combination of analgesics provide proper postoperative pain control after major gynecologic cancer surgeries without any significant complications. Regarding lower sedative and respiratory depressant effects of epidural analgesia, it seems that this method is a safer technique for postoperative pain relief in these patients.

Project description:The predictors of postoperative pain and analgesic consumption were previously found to include preoperative pain, anxiety, age, type of surgery, and genotype, but remaining unclear was whether intraoperative factors could predict postoperative pain. In the present study, we investigated the time-course of fentanyl consumption using intravenous patient-controlled analgesia records from patients who underwent orthognathic surgery for mandibular prognathism and analyzed the influence of anesthesia methods and surgical methods together with sex on the time course. A significant difference in the time course of fentanyl administration was found (P<0.001). No significant difference in the time course of fentanyl administration was found between males and females (P = 0.653), with no interaction between time course and sex (P = 0.567). No significant difference in the time course of fentanyl administration was found among anesthesia methods, such as fentanyl induction followed by fentanyl maintenance, fentanyl induction followed by remifentanil maintenance, and remifentanil induction followed by remifentanil maintenance (P = 0.512), but an interaction between time course and anesthesia method was observed (P = 0.004). A significant difference in the time course of fentanyl administration was found between surgical methods, such as bilateral mandibular sagittal split ramus osteotomy (BSSRO) and BSSRO combined with Le Fort I osteotomy (bimaxillary; P = 0.008), with no interaction between time course and surgical method (P = 0.535). Total postoperative 24 h consumption associated with the bimaxillary procedure was significantly higher than with BSSRO (P = 0.008). The present results indicate that administration patterns and total 24 h consumption were different among the three groups of anesthesia methods and between the two groups of surgical methods, respectively. Although more research on patient-controlled analgesia patterns and consumption is necessary, the present study will contribute to adequately relieving individual patients from postoperative pain.

Project description:BACKGROUND:This is an updated version of the original Cochrane review published in Issue 4, 2006. Patients may control postoperative pain by self administration of intravenous opioids using devices designed for this purpose (patient controlled analgesia or PCA). A 1992 meta-analysis by Ballantyne et al found a strong patient preference for PCA over non-patient controlled analgesia, but disclosed no differences in analgesic consumption or length of postoperative hospital stay. Although Ballantyne's meta-analysis found that PCA did have a small but statistically significant benefit upon pain intensity, a 2001 review by Walder et al did not find statistically significant differences in pain intensity or pain relief between PCA and groups treated with non-patient controlled analgesia. OBJECTIVES:To evaluate the efficacy and safety of patient controlled intravenous opioid analgesia (termed PCA in this review) versus non-patient controlled opioid analgesia of as-needed opioid analgesia for postoperative pain relief. SEARCH METHODS:We ran the search for the previous review in November 2004. For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 12), MEDLINE (1966 to 28 January 2015), and EMBASE (1980 to 28 January 2015) for randomized controlled trials (RCTs) in any language, and reference lists of reviews and retrieved articles. SELECTION CRITERIA:We selected RCTs that assessed pain intensity as a primary or secondary outcome. These studies compared PCA without a continuous background infusion with non-patient controlled opioid analgesic regimens. We excluded studies that explicitly stated they involved patients with chronic pain. DATA COLLECTION AND ANALYSIS:Two review authors independently extracted data, which included demographic variables, type of surgery, interventions, efficacy, and adverse events. We graded each included study for methodological quality by assessing risk of bias and employed the GRADE approach to assess the overall quality of the evidence. We performed meta-analysis of outcomes that included pain intensity assessed by a 0 to 100 visual analog scale (VAS), opioid consumption, patient satisfaction, length of stay, and adverse events. MAIN RESULTS:Forty-nine studies with 1725 participants receiving PCA and 1687 participants assigned to a control group met the inclusion criteria. The original review included 55 studies with 2023 patients receiving PCA and 1838 patients assigned to a control group. There were fewer included studies in our updated review due to the revised exclusion criteria. For the primary outcome, participants receiving PCA had lower VAS pain intensity scores versus non-patient controlled analgesia over most time intervals, e.g., scores over 0 to 24 hours were nine points lower (95% confidence interval (CI) -13 to -5, moderate quality evidence) and over 0 to 48 hours were 10 points lower (95% CI -12 to -7, low quality evidence). Among the secondary outcomes, participants were more satisfied with PCA (81% versus 61%, P value = 0.002) and consumed higher amounts of opioids than controls (0 to 24 hours, 7 mg more of intravenous morphine equivalents, 95% CI 1 mg to 13 mg). Those receiving PCA had a higher incidence of pruritus (15% versus 8%, P value = 0.01) but had a similar incidence of other adverse events. There was no difference in the length of hospital stay. AUTHORS' CONCLUSIONS:Since the last version of this review, we have found new studies providing additional information. We reanalyzed the data but the results did not substantially alter any of our previously published conclusions. This review provides moderate to low quality evidence that PCA is an efficacious alternative to non-patient controlled systemic analgesia for postoperative pain control.

Project description:IntroductionThis study aimed to compare the efficacy between patient-controlled caudal epidural analgesia (PCCA) and patient-controlled intravenous analgesia (PCIA) after perianal surgery, to provide a feasible solution to postoperative pain.MethodsThis was a prospective, randomized controlled trial comprising 100 patients who underwent caudal epidural block on perianal surgery at Chengdu Shang Jin Nan Fu Hospital of West China Hospital at Sichuan University between April and August 2020. Patients were randomly divided into the PCCA and PCIA groups. Visual analog scale (VAS) scores were recorded at 2, 4, 6, 24, 48, and 72 h after surgery, and at the first dressing change and first defecation. The lower limb mobility in the post-anesthetic recovery room (PACU) was determined. The analgesic effect, usage amount of patient-controlled analgesia (PCA), usage amount and frequency of remedial analgesic measures, number of individuals who must be catheterized, and incidence of adverse reactions were recorded. Satisfaction of postoperative analgesic effect and convenience of PCA were also assessed.ResultsThe patients in the PCCA group had significantly lower VAS scores at 4, 6, 24, 48, 72 h, the first dressing change, and the first defecation compared with the PCIA group. There were more patients receiving postoperative remedial analgesics in the PCIA group than in the PCCA group. The outcome of the number of PCA and catheterization rates did not differ significantly between the groups. There were two cases of sensory numbness below the S3 plane. The major postoperative complications in the PCIA group were pruritus (3/47, 6.4%), nausea, and vomiting (6/47, 12.8%) (one case combined with pruritus). Patients in the PCCA group were more satisfied with the analgesic effect, while those in the PCIA group were more satisfied with the convenience.ConclusionIn the postoperative analgesia program of perianal surgery, PCCA may provide a better analgesic effect without increasing the incidence of complications.Trial registrationChinese Clinical Trial Registry identifier, ChiCTR2000038425, September 2020, retrospectively registered.

Dataset Information

Comparing efficacy and safety between Naldebain® and intravenous patient-controlled analgesia with fentanyl for pain management post-laparotomy: study protocol for a randomized controlled, non-inferior trial.

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Comparing efficacy and safety between Naldebain<sup>®</sup> and intravenous patient-controlled analgesia with fentanyl for pain management post-laparotomy: study protocol for a randomized controlled, non-inferior trial.

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