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
調査の概要
詳細な説明
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).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Santiago Metropolitan
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Santiago、Santiago Metropolitan、チリ、8431657
- 募集
- Clínica Dávila
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コンタクト：
- Alejandra Sofía Rivera, MsC Epidemiology
- 電話番号：930363776
- メール：alejandra.rivera@davila.cl
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コンタクト：
- Bernarda Miranda, Bibliotecary
- 電話番号：+56930363776
- メール：bmiranda@davila.cl
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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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プラセボコンパレーター：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative Pain Intensity Measured Using the Numeric Rating Scale
時間枠：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.
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24, 48, and 72 hours and 7 days after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative Rescue Opioid Consumption
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CD2025/035
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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