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

Tri-Service General Hospital76 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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".

Time frame: 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).

Time frame: Within 1 day after surgery

Secondary Outcomes

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".

Time frame: 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.

Time frame: 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.

Time frame: Up to 7 days after surgery

Brief Pain Inventory

Time frame: 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.

Time frame: 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.