Naldebain for Pain Control After Bariatric Surgery

NCT04651361 | Unknown Phase 2

• 1 other identifier: EMRP-73109N
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pain, Postoperative; Pain, Chronic; Bariatric Surgery; Obesity; Pharmacokinetics

Keywords

Nalbupine; Dinalbuphine sebacate; Naldebain; Opioid; Laparoscopic gastric sleeve surgery; Laparoscopic gastric bypass surgery

Outcome Measures

Primary Outcomes (2)

• Acute postoperative pain

  Pain score measured by visual analogue scale (VAS 1-10, a continuum scale in which 0 represents "no pain" and and 10 represents "worst pain.")

  7 days after operation

• Total requirement dose of rescue analgesics

  Total doses of opioids, NSAIDs, COX-2 inhibitors administered

  7 days after operation

Secondary Outcomes (2)

• Incidence of chronic post-surgical pain

  3 months after operation

• Quality of life after surgery

  3 months after operation

Study Arms (2)

Naldebain group

ACTIVE COMPARATOR

Patients assigned to Naldebain® group will receive a single intramuscular injection of dinalbuphine sebacate (150 mg in 2 ml solvent containing benzyl benzoate and sesame oil) into the gluteus muscles under ultrasound-guidance.

Drug: Dinalbuphine sebacate

Placebo group

PLACEBO COMPARATOR

Patients assigned to placebo group will receive a single intramuscular injection of 2 ml solvent containing benzyl benzoate and sesame oil into the gluteus muscles under ultrasound-guidance.

Drug: Placebo solution

Interventions

Dinalbuphine sebacate DRUG

Naldebain dissolved in benzyl benzoate and sesame oil (a total volume of 2ml) will be prepared in a 5-ml syringe 30 min before administration. Intramuscular injection into the gluteal muscles will be performed by an anesthesiologist under sonography-guidance.

Also known as: Naldebain ER®, Sebacoyl Dinalbuphine Ester Injection

Naldebain group

Placebo solution DRUG

Benzyl benzoate and sesame oil served as placebo solution (a total volume of 2ml) will be prepared in a 5-ml syringe 30 min before administration. Intramuscular injection into the gluteal muscles will be performed by an anesthesiologist under sonography-guidance.

Placebo group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• E-DA Hospital: lead

Study Sites (2)

E-Da Hospital

Yanchao, Kaohsiung, 824, Taiwan

RECRUITING

E-Da Hospital

Yanchao, Kaohsiung, 824, Taiwan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain; Obesity

Interventions

sebacoyl dinalbuphine ester

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight

Study Officials

• Chen-Fuh Lam, MD, PhD

  E-Da Hospital, Kaohsiung, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen-Fuh Lam, MD, PhD

CONTACT

+8867-6150011; lamcf@ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Naldebain (active drug in solvent containing benzyl benzoate and sesame oil) or placebo drug (solvent containing benzyl benzoate and sesame oil) will be prepared by the clinical pharmacists in an identical injection syringe within 30 min before injection. The participants, anesthesiologists, surgeons, investigators and outcomes assessors will be blinded to the treatment groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Orthopedics and Superintendent

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 3, 2020
• Study Start: June 24, 2021
• Primary Completion: March 31, 2022
• Study Completion: June 30, 2022
• Last Updated: December 28, 2021

Record last verified: 2021-12

Locations

TW (2)