Naldebain for Pain Control After Bariatric Surgery
Status:
Recruiting
Trial end date:
2022-01-31
Target enrollment:
Participant gender:
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.