Naldebain for Pain Control After Bariatric Surgery

• Status: Recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: All

Summary

Laparoscopic gastric sleeve and bypass surgeries the most common bariatric procedures for weight loss and improved management of metabolic syndromes. Patients may suffer from wound pain or referred pain after laparoscopic bariatric operation. Most importantly, 11.8% of these patients complained surgical-related pain one year after operation, and 8% of them required prolonged use of opioid to control chronic postoperative pain (CPSP). However, there are currently lack of clinical practice guidelines or recommendations for prevention of CPSP after laparoscopic abdominal surgery. Although regional block techniques (i.e. truncal block or intrathecal opioid) are considered as effective supplementary analgesic approaches to improve postoperative pain control, parenteral administration of analgesics remain as the mainstay for pain management of laparoscopic abdominal surgery. Naldebain® is prodrug of nalbuphine, which was approved by the Taiwan FDA in 2017. Naldebain® is an extended-release dinalbuphine sebacate, and is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine. A number of clinical studies have shown that single-dose of pre-operative intramuscular administration of Naldebain® provides significantly higher analgesic effect up to 1 week in hemorrhoidectomy and laparotomy surgery with a well-tolerated safety profile. Therefore, this PI-initiated randomized, double-blind, placebo-control trial aims to investigate the clinical efficacy of Naldebain® in management of acute postoperative pain in patients receiving laparoscopic gastric sleeve or bypass surgery, and prevention of the development of CPSP after surgery. This study will also analyze the plasma levels of nalbuphine following a single intramuscular injection in obese patients.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: E-DA Hospital

Criteria

Inclusion Criteria:

• Patient scheduled to receive laparoscopic gastric sleeve surgery or laparoscopic gastric bypass surgery

Exclusion Criteria:

• Laparotomy bariatric surgery

• American Society of Anesthesiologists physical status > or =4

• Chronic opioid user

• Allergy to nalbuphine, benzyl benzoate or sesame oil

• Anticipated to receive ventilator support via an endotracheal tube after operation

• Not able for verbal pain assessment or not able to participate questionnaire survey