Analgesia With Transdermal Buprenorphine Patch in Adults Undergoing Video-Assisted Thoracoscopic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Buprenorphine (BUP), Placebo.
- Who it may be relevant to
- Registry conditions: Postoperative Pain, Thoracic Surgery, Video-Assisted Thoracoscopic Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Chile
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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).
Interventions
- Drug Buprenorphine (BUP)
Transdermal buprenorphine patch (5 mcg/hour) administered preoperatively as part of multimodal analgesia. - Other Placebo
Placebo transdermal patch identical in appearance to the active patch and administered preoperatively as part of multimodal analgesia.
Primary outcome measures
- Postoperative Pain Intensity Measured Using the Numeric Rating Scale [Time frame: 24, 48, and 72 hours and 7 days after surgery]
Secondary outcome measures (5)
- Postoperative Rescue Opioid Consumption [Time frame: From the end of surgery through 7 days after surgery]
- Incidence of Postoperative Nausea and Vomiting [Time frame: 24, 48, and 72 hours and 7 days after surgery]
- Incidence of Postoperative Pruritus [Time frame: 24, 48, and 72 hours and 7 days after surgery]
- Incidence of Postoperative Urinary Retention Requiring Bladder Catheterization [Time frame: 24, 48, and 72 hours and 7 days after surgery]
- Length of Hospital Stay [Time frame: From the day of surgery until hospital discharge, assessed up to 30 days]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Chile · 1 center
- Clínica Dávila — Santiago
Identifiers
NCT: NCT07733128 · CD2025/035