Analgesia With Transdermal Buprenorphine Patch in Adults Undergoing Video-Assisted Thoracoscopic Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClínica Dávila
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Known allergy or hypersensitivity to buprenorphine or any component of the transdermal patch.
Chronic opioid use before surgery.
Severe hepatic impairment.
Pregnancy or breastfeeding.
Trial design
Design model
Parallel
Treatments tested in this trial
Buprenorphine (BUP)
DrugTransdermal buprenorphine patch (5 mcg/hour) administered preoperatively as part of multimodal analgesia.
Placebo
Other interventionPlacebo transdermal patch identical in appearance to the active patch and administered preoperatively as part of multimodal analgesia.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Buprenorphine PatchExperimental treatment 1 intervention
Group B: Placebo PatchPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative 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 surgerySecondary outcomes
1
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 surgery2
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 surgery3
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 surgery4
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 surgerySponsors and contacts
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Source ClinicalTrials.gov