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

NCT05115955 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-04-09

No results posted yet for this study

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

Interventions

DRUG

DS group

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

DRUG

Control group

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

Sponsors & Collaborators

  • Tri-Service General Hospital

    lead OTHER

Principal Investigators

  • Chueng-He Lu, M.D. · Tri-Service General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-11
Primary Completion
2024-05-31
Completion
2024-06-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05115955 on ClinicalTrials.gov