Analgesia With a 5 mcg/Hour Transdermal Buprenorphine Patch as Part of Multimodal Analgesia in Adults Undergoing Unilateral Video-Assisted Thoracoscopic Surgery: A Triple-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity Measured Using the Numeric Rating Scale
研究概览
简要总结
Postoperative pain remains a major challenge after video-assisted thoracoscopic surgery (VATS), despite the use of multimodal analgesia. This randomized, triple-blind, placebo-controlled clinical trial will evaluate whether adding a 5 mcg/hour transdermal buprenorphine patch to the standard multimodal analgesic regimen reduces postoperative pain in adults undergoing unilateral VATS. Participants will be randomly assigned to receive either transdermal buprenorphine or placebo in addition to standard analgesia. Postoperative pain will be assessed at 24, 48, and 72 hours and 7 days after surgery. Secondary outcomes include opioid rescue requirements, length of hospital stay, postoperative nausea and vomiting, pruritus, and urinary retention.
详细描述
Video-assisted thoracoscopic surgery (VATS) is associated with moderate to severe postoperative pain that may impair respiratory function, delay recovery, prolong hospitalization, and contribute to the development of persistent postoperative pain. Current guidelines recommend multimodal analgesia, including non-opioid analgesics and regional anesthesia techniques, while opioids are generally reserved for rescue analgesia.
Transdermal buprenorphine is a long-acting partial μ-opioid receptor agonist that has demonstrated efficacy in reducing postoperative pain and opioid consumption in several surgical settings. However, evidence regarding its use in thoracic surgery is currently lacking.
This is a single-center, randomized, triple-blind, placebo-controlled clinical trial conducted at Clínica Dávila, Santiago, Chile. Adult patients undergoing unilateral video-assisted thoracoscopic surgery will be randomized in a 1:1 ratio to receive either a 5 mcg/hour transdermal buprenorphine patch plus standard multimodal analgesia or placebo plus standard multimodal analgesia. Randomization will be computer-generated using sequentially numbered opaque sealed envelopes. Participants, investigators, outcome assessors, and the statistician will remain blinded to treatment allocation.
The primary outcome is postoperative pain intensity measured using the Numeric Rating Scale (0-10) at 24, 48, and 72 hours and 7 days after surgery. Secondary outcomes include opioid rescue consumption expressed as morphine equivalents, postoperative nausea and vomiting, pruritus, urinary retention, and length of hospital stay. The planned sample size is 90 participants (45 per group).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care providers, investigators responsible for outcome assessment, and the study statistician will remain blinded to treatment allocation. Participants in both groups will receive an identical opaque dressing to maintain masking. Randomization codes will remain concealed until completion of the statistical analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older.
- •Scheduled for elective unilateral video-assisted thoracoscopic surgery (VATS).
- •American Society of Anesthesiologists (ASA) physical status I-III.
- •Able to understand the study procedures and provide written informed consent.
排除标准
- •Known allergy or hypersensitivity to buprenorphine or any component of the transdermal patch.
- •Chronic opioid use before surgery.
- •Severe hepatic impairment.
- •Pregnancy or breastfeeding.
- •Inability to complete postoperative pain assessments.
- •Any condition that, in the investigator's opinion, could interfere with study participation or outcome assessment.
研究组 & 干预措施
Buprenorphine Patch
Participants will receive a 5 mcg/hour transdermal buprenorphine patch before surgery in addition to standard multimodal analgesia.
干预措施: Buprenorphine (BUP) (Drug)
结局指标
主要结局
Postoperative Pain Intensity Measured Using the Numeric Rating Scale
时间窗: 24, 48, and 72 hours and 7 days after surgery
Postoperative pain intensity will be assessed using the Numeric Rating Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be compared between the buprenorphine and placebo groups across the postoperative assessment time points.
次要结局
- Postoperative Rescue Opioid Consumption(From the end of surgery through 7 days after surgery)
- Incidence of Postoperative Nausea and Vomiting(24, 48, and 72 hours and 7 days after surgery)
- Incidence of Postoperative Pruritus(24, 48, and 72 hours and 7 days after surgery)
- Incidence of Postoperative Urinary Retention Requiring Bladder Catheterization(24, 48, and 72 hours and 7 days after surgery)
- Length of Hospital Stay(From the day of surgery until hospital discharge, assessed up to 30 days)