Postoperative Pain Management With Extended-release Dinalbuphine Sebacate in Patients Undergoing Arthroscopic Shoulder Surgery: a Randomized,Double-blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Acute postoperative pain intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo arthroscopic shoulder surgery.
- •American Society of Anesthesiology Physical Class 1-
- •Ability and willingness to provide informed consent.
排除标准
- •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.
研究组 & 干预措施
Control group
Combination of routine analgesic regimen and preoperative administration of 2 ml sesame oil (2 ml/vial).
干预措施: Control group (Drug)
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).
干预措施: DS group (Drug)
结局指标
主要结局
Acute postoperative pain intensity
时间窗: 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".
Brief Pain Inventory
时间窗: 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).
次要结局
- Postoperative pain intensity(In postanesthesia care unit (PACU), and 6 hours, 7 days, 90 days, and 180 days after surgery)
- Consumption of analgesics(Within 7 days after surgery)
- Time to the first dose of rescue medication(Up to 7 days after surgery)
- Brief Pain Inventory(At baseline, 1 day, 7 days, 90 days, 180 days after surgery)
- Satisfaction assessed by a 5-point scale(7 days after surgery)
- Incidence of adverse events(Within 7 days after surgery)
研究者
Chueng-He Lu
Principal Investigator
Tri-Service General Hospital