Postoperative Pain, Thoracic Surgery, Video-Assisted Thoracoscopic Surgery
Conditions
Keywords
Buprenorphine, Transdermal Patch, Multimodal Analgesia, Video-Assisted Thoracoscopic Surgery, VATS, Postoperative Pain, Randomized Controlled Trial, Thoracic Surgery, Acute Pain, Opioid Analgesia
Brief summary
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
Transdermal buprenorphine patch (5 mcg/hour) administered preoperatively as part of multimodal analgesia.
OTHERPlacebo
Placebo transdermal patch identical in appearance to the active patch and administered preoperatively as part of multimodal analgesia.
Sponsors
Clínica Dávila
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be randomly assigned 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity Measured Using the Numeric Rating Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Rescue Opioid Consumption | From the end of surgery through 7 days after surgery | 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. |
| Incidence of Postoperative Nausea and Vomiting | 24, 48, and 72 hours and 7 days after surgery | 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. |
| Incidence of Postoperative Pruritus | 24, 48, and 72 hours and 7 days after surgery | 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. |
| Incidence of Postoperative Urinary Retention Requiring Bladder Catheterization | 24, 48, and 72 hours and 7 days after surgery | 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. |
| Length of Hospital Stay | From the day of surgery until hospital discharge, assessed up to 30 days | 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. |
Countries
Chile
Outcome results
None listed