Analgesia With Transdermal Buprenorphine Patch in Adults Undergoing Video-Assisted Thoracoscopic Surgery

NCT07733128 | Recruiting

• 1 other identifier: CD2025/035
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Thoracic Surgery; Video-Assisted Thoracoscopic Surgery

Keywords

Buprenorphine; Transdermal Patch; Multimodal Analgesia; Video-Assisted Thoracoscopic Surgery; VATS; Postoperative Pain; Randomized Controlled Trial; Thoracic Surgery; Acute Pain; Opioid Analgesia

Outcome Measures

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.

  24, 48, and 72 hours and 7 days after surgery

Secondary Outcomes (5)

• 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

Study Arms (2)

Buprenorphine Patch

EXPERIMENTAL

Participants will receive a 5 mcg/hour transdermal buprenorphine patch before surgery in addition to standard multimodal analgesia.

Drug: Buprenorphine (BUP)

Placebo Patch

PLACEBO COMPARATOR

Participants will receive a placebo transdermal patch before surgery in addition to standard multimodal analgesia.

Other: Placebo

Interventions

Buprenorphine (BUP) DRUG

Transdermal buprenorphine patch (5 mcg/hour) administered preoperatively as part of multimodal analgesia.

Buprenorphine Patch

Placebo OTHER

Placebo transdermal patch identical in appearance to the active patch and administered preoperatively as part of multimodal analgesia.

Placebo Patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clínica Dávila: lead

Study Sites (1)

Clínica Dávila

Santiago, Santiago Metropolitan, 8431657, Chile

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Acute Pain

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)