PO Pain Management With Extended-release Dinalbuphine Sebacate in Patients Undergoing Arthroscopic Shoulder Surgery

NCT05115955 | Completed Phase 4

• 1 other identifier: B202105153
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain is common, and the pain intensity can be moderate to severe depending on the site of surgery during the first few days after surgery, and an estimated 15% to 45% experience chronic postsurgical pain. When poorly controlled, the pain can have a significant effect on patient recovery. Proper management of postoperative pain is needed to relieve suffering and lead to earlier mobilization, shortened hospital stay, reduced hospital costs, and increased patient satisfaction. The currently proposed clinical use of Dinalbuphine Sebacate is to administer a single dose of NALDEBAIN® intramuscularly approximately 12 to 24 hours prior to the planned surgery for pain relief. Several clinical studies of NALDEBAIN® have been published, such as the use in laparotomy and laparoscopic cholecystectomy. However, toward the arthroscopic shoulder surgery, no article or report has been available publicly yet. The primary objective of this study is to determine the safety and efficacy of single doses of intramuscular NALDEBAIN® on patients scheduled to undergo arthroscopic shoulder surgery.

Conditions

Anesthesiology; Orthopedic

Keywords

Analgesia; Acute postoperative pain; Arthroscopic shoulder surgery; Randomized controlled study (RCT); Dinalbuphine sebacate; NALDEBAIN

Outcome Measures

Primary Outcomes (2)

• Acute postoperative pain intensity

  Mean pain intensity scored by numeric rating scale (NRS). Numerical Rating Scale (NRS) was a 11-point scale on which 0 represented "no pain" and 10 represented the" worst pain ever".

  Within 1 day after surgery

• Brief Pain Inventory

  Mean scores of each item in Brief Pain Inventory (BPI). Patients fill out 11 different NRS that ask about pain intensity and the effect of the pain on their ability to function during various activities of daily living. The severity scores range from 0 (no pain) to 10 (the most severe pain).

  Within 1 day after surgery

Secondary Outcomes (6)

• Postoperative pain intensity

  In postanesthesia care unit (PACU), and 6 hours, 7 days, 90 days, and 180 days after surgery

• Consumption of analgesics

  Within 7 days after surgery

• Time to the first dose of rescue medication

  Up to 7 days after surgery

• Brief Pain Inventory

  At baseline, 1 day, 7 days, 90 days, 180 days after surgery

• Satisfaction assessed by a 5-point scale

  7 days after surgery

Study Arms (2)

DS group

EXPERIMENTAL

Combination of routine analgesic regimen and preoperative administration of 2 ml NALDEBAIN® ER Injection (150 mg Dinalbuphine Sebacate, 75 mg/ml, 2 ml/vial).

Drug: DS group

Control group

PLACEBO COMPARATOR

Combination of routine analgesic regimen and preoperative administration of 2 ml sesame oil (2 ml/vial).

Drug: Control group

Interventions

DS group DRUG

In DS group, subjects will receive intramuscular single dose of NALDEBAIN® at least 12 hours before surgery.

Also known as: NALDEBAIN®

DS group

Control group DRUG

In Control group, subjects will receive intramuscular 2 ml sesame oil at least 12 hours before surgery.

Also known as: Sesame oil

Control group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo arthroscopic shoulder surgery.
• American Society of Anesthesiology Physical Class 1-3.
• Ability and willingness to provide informed consent.

You may not qualify if:

• Not willing to adhere to the study visit schedule.
• With a history of hypersensitivity or allergy to opioids, NSAIDs or sesame oil.
• With a medical history that may predispose them to abnormal intracranial pressure.
• Any history of narcotic dependency, addiction, or withdrawal.
• Any clinically significant condition that may interfere with study assessments.
• Pregnant or breastfeeding.
• Nonregular sinus cardiac rhythm or implanted pacemakers.
• Prescribed antimuscarinic agents, α2-adrenergic agonists, β1-adrenergic antagonists, or antiarrhythmic agents.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Taiwan, 114, Taiwan

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Control Groups; Sesame Oil

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Chueng-He Lu, M.D.

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 10, 2021
• Study Start: November 11, 2021
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: April 9, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)