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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Anesthesiology, Orthopedic

Intervention / Treatment
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* Drug: DS group
* Drug: Control group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute postoperative pain, Analgesia, Arthroscopic shoulder surgery, Randomized controlled study (RCT), Dinalbuphine sebacate, NALDEBAIN