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

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

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.

Study Overview

• Status: Completed
• Conditions: Orthopedic; Anesthesiology
• Intervention / Treatment: Drug: DS group; Drug: Control group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taipei city, Taiwan, 114
    • Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DS group; 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; In DS group, subjects will receive intramuscular single dose of NALDEBAIN® at least 12 hours before surgery.; Other Names: NALDEBAIN®
Placebo Comparator: Control group; Combination of routine analgesic regimen and preoperative administration of 2 ml sesame oil (2 ml/vial).	Drug: Control group; In Control group, subjects will receive intramuscular 2 ml sesame oil at least 12 hours before surgery.; Other Names: Sesame oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	In postanesthesia care unit (PACU), and 6 hours, 7 days, 90 days, and 180 days after surgery
Consumption of analgesics	The consumption of total amount (mg) of supplemental analgesics administered after surgery.	Within 7 days after surgery
Time to the first dose of rescue medication	Time from the end of surgery to the first rescue medication use.	Up to 7 days 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).	At baseline, 1 day, 7 days, 90 days, 180 days after surgery
Satisfaction assessed by a 5-point scale	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.	7 days after surgery
Incidence of adverse events	The incidence of postoperative adverse events occurring during 7 days after surgery, especially the ones related to analgesics.	Within 7 days after surgery

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital
• Investigators: Principal Investigator: Chueng-He Lu, M.D., Tri-Service General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): May 31, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: November 6, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Dinalbuphine sebacate; NALDEBAIN; Analgesia; Acute postoperative pain; Arthroscopic shoulder surgery; Randomized controlled study (RCT)
• Other Study ID Numbers: B202105153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No