Analgesia With Transdermal Buprenorphine Patch in Adults Undergoing Video-Assisted Thoracoscopic Surgery
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
연구 개요
상세 설명
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).
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, 칠레, 8431657
- 모병
- Clínica Dávila
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연락하다:
- Alejandra Sofía Rivera, MsC Epidemiology
- 전화번호: 930363776
- 이메일: alejandra.rivera@davila.cl
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연락하다:
- Bernarda Miranda, Bibliotecary
- 전화번호: +56930363776
- 이메일: bmiranda@davila.cl
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Buprenorphine Patch
Participants will receive a 5 mcg/hour transdermal buprenorphine patch before surgery in addition to standard multimodal analgesia.
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Transdermal buprenorphine patch (5 mcg/hour) administered preoperatively as part of multimodal analgesia.
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위약 비교기: Placebo Patch
Participants will receive a placebo transdermal patch before surgery in addition to standard multimodal analgesia.
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Placebo transdermal patch identical in appearance to the active patch and administered preoperatively as part of multimodal analgesia.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Pain Intensity Measured Using the Numeric Rating Scale
기간: 24, 48, and 72 hours and 7 days after surgery
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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.
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24, 48, and 72 hours and 7 days after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Postoperative Rescue Opioid Consumption
기간: From the end of surgery through 7 days after surgery
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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.
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From the end of surgery through 7 days after surgery
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Incidence of Postoperative Nausea and Vomiting
기간: 24, 48, and 72 hours and 7 days after surgery
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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.
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24, 48, and 72 hours and 7 days after surgery
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Incidence of Postoperative Pruritus
기간: 24, 48, and 72 hours and 7 days after surgery
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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.
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24, 48, and 72 hours and 7 days after surgery
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Incidence of Postoperative Urinary Retention Requiring Bladder Catheterization
기간: 24, 48, and 72 hours and 7 days after surgery
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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.
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24, 48, and 72 hours and 7 days after surgery
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Length of Hospital Stay
기간: From the day of surgery until hospital discharge, assessed up to 30 days
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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.
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From the day of surgery until hospital discharge, assessed up to 30 days
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CD2025/035
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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