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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Transdermal buprenorphine patch (5 mcg/hour) administered preoperatively as part of multimodal analgesia.
Placebo transdermal patch identical in appearance to the active patch and administered preoperatively as part of multimodal analgesia.
Clínica Dávila
Santiago, Santiago Metropolitan, Chile
RECRUITINGPostoperative Pain Intensity Measured Using the Numeric Rating Scale
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.
Time frame: 24, 48, and 72 hours and 7 days after surgery
Postoperative Rescue Opioid Consumption
Total rescue opioid consumption will be obtained from the clinical record and expressed in milligrams of intravenous morphine equivalents. Opioid consumption will be compared between the study groups.
Time frame: From the end of surgery through 7 days after surgery
Incidence of Postoperative Nausea and Vomiting
The presence or absence of postoperative nausea or vomiting will be recorded at each postoperative assessment. The outcome will be reported as the number and percentage of participants experiencing nausea or vomiting in each study group.
Time frame: 24, 48, and 72 hours and 7 days after surgery
Incidence of Postoperative Pruritus
The presence or absence of postoperative pruritus will be recorded at each assessment. The outcome will be reported as the number and percentage of participants experiencing pruritus in each study group.
Time frame: 24, 48, and 72 hours and 7 days after surgery
Incidence of Postoperative Urinary Retention Requiring Bladder Catheterization
Postoperative urinary retention will be defined as the need for bladder catheterization. The outcome will be reported as the number and percentage of participants requiring catheterization in each study group.
Time frame: 24, 48, and 72 hours and 7 days after surgery
Length of Hospital Stay
Length of hospital stay will be calculated as the number of complete days from the postoperative period until hospital discharge, based on the electronic clinical record.
Time frame: From the day of surgery until hospital discharge, assessed up to 30 days
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