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Completed

NCT Number: NCT05115955

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

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.

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tri-Service General Hospital

Taipei, Taiwan, 114

About this study

This is a randomized, double-blind, placebo controlled study. Patients scheduled to undergo arthroscopic shoulder surgery will be invited to participate in this study. After obtaining the written informed consent, each subject should be sequentially assigned an individual screening number instead of his/her name, chart number or identification. Subjects will be randomized to two groups, DS group and Control group. Both groups should be treated with both routine analgesic regimen and a dose of investigational product. Random numbers and assignment treatment were generated by computer program before this study initiated. Statistical analyses should be performed on the data to compare the two groups. Numerical variables will be present with mean and standard deviation and categorical variables will be present with number and percentage.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

DS group

Drug

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

Other names: NALDEBAIN®

Control group

Drug

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

Other names: Sesame oil

Primary outcomes

  1. Acute postoperative pain intensity

    Time frame: Within 1 day after surgery

    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".

  2. Brief Pain Inventory

    Time frame: Within 1 day after surgery

    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).

Secondary outcomes

  1. Postoperative pain intensity

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

    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".

  2. Consumption of analgesics

    Time frame: Within 7 days after surgery

    The consumption of total amount (mg) of supplemental analgesics administered after surgery.

  3. Time to the first dose of rescue medication

    Time frame: Up to 7 days after surgery

    Time from the end of surgery to the first rescue medication use.

  4. Brief Pain Inventory

    Time frame: At baseline, 1 day, 7 days, 90 days, 180 days after surgery

    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).

  5. Satisfaction assessed by a 5-point scale

    Time frame: 7 days after surgery

    Each subject should be asked the following question: "How satisfied were you with your post-surgical analgesia"? Subjects should be asked to classify themselves as either: 1=highly satisfied, 2=satisfied, 3=uncertain, 4=dissatisfied or 5=very dissatisfied.

  6. Incidence of adverse events

    Time frame: Within 7 days after surgery

    The incidence of postoperative adverse events occurring during 7 days after surgery, especially the ones related to analgesics.

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

Postoperative Pain Management With Extended-release Dinalbuphine Sebacate in Patients Undergoing Arthroscopic Shoulder Surgery: a Randomized,Double-blind Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Nov 10, 2021
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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