Local Wound Infiltration Plus TAP Block Versus Local Wound Infiltration Only
Comparison of Analgesic Efficacy of Local Wound Infiltration Plus Transversus Abdominis Plane Block and Local Wound Infiltration Only After Laparoscopic Colorectal Resection: a Randomized, Double-blind, Non-inferiority Trial
The TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic visualization (TAP-LAP): comparison between these two technics showed no differences in pain control and use of opioid analgesics.
The investigators hypothesize that WI is non-inferior to WI + TAP-block with respect to postoperative pain.
調査の概要
詳細な説明
In colorectal surgery, laparoscopy and enhanced recovery after surgery (ERAS) programs have significantly improved the short-term outcomes (1). Although the laparoscopic approach reduces pain and recovery time, post-operative pain, nausea and vomiting still represent an issue. In order to reduce opioid related side effects, such as postoperative nausea and vomiting (PONV), constipation and prolonged post-operative ileus, non-opioid based multimodal analgesia have been recently introduced. Although epidural analgesia has gained good success, it does not seem to offer any additional clinical benefits to patients undergoing laparoscopic colorectal surgery compared to alternative analgesic technique within an ERAS program. Both local wound infiltration (WI) and TAP block are common techniques in multimodal postoperative pain treatment, and their association allows to achieve pain control despite a reduced use of opioid analgesics. Furthermore, in a recent single-blind prospective study TAP block resulted superior to wound infiltration alone. The TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic visualization (TAP-LAP): comparison between these two technics showed no differences in pain control and use of opioid analgesics.
The aim of this study is to compare WI + TAP-LAP versus WI alone. The investigators hypothesize that WI is non-inferior to WI + TAP-block with respect to postoperative pain.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Aged 18-80 years, either sex
- Patients scheduled to undergo elective laparoscopic colorectal surgery under general anesthesia
- Willingness and ability to sign an informed consent document
Exclusion Criteria:
- Allergies to anesthetic or analgesic medications
- Contraindication to the use of locoregional anesthesia
- Chronic opioid use
- Coagulopathy, Impaired kidney function, uncontrolled diabetes, psychiatric disorders, severe cardiovascular impairment or chronic obstructive lung disease
- Necessity of major resection other than colorectal, palliative surgery
- BMI above 35 kg/m2
- American Society of Anesthesiologists (ASA) physical status above 3
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:トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:Wound infiltration plus TAP
Wound infiltration placed by surgeon + TAP-LAP placed laparoscopically guided by surgeon
|
他の名前:
|
|
アクティブコンパレータ:Wound infiltration
Wound infiltration placed by surgeon
|
Wound infiltration of ropivacaine will be performed by the surgeon before skin incision.
他の名前:
|
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 |
|---|---|---|
|
Pain numerical rating scale (NRS)
時間枠:within the first 6 hours after surgery
|
|
within the first 6 hours after surgery
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
最初の経口液体摂取までの時間
時間枠:手術後8週間
|
手術後の最初の経口液体摂取までの時間
|
手術後8週間
|
|
最初の経口ソフトダイエットまでの時間
時間枠:手術後8週間
|
手術後の最初の経口軟食までの時間
|
手術後8週間
|
|
入院期間
時間枠:手術後8週間
|
入院後の入院期間
|
手術後8週間
|
|
Pain NRS
時間枠:12, 24, 36, 48, 72 hour after surgery
|
|
12, 24, 36, 48, 72 hour after surgery
|
|
Rescue opioid analgesic requirement
時間枠:postoperative day 0, 1, 2, 3
|
Overall postoperative rescue of opioid analgesic requirement described by using the Defined Daily Dose
|
postoperative day 0, 1, 2, 3
|
|
Postoperative nausea and vomiting scale
時間枠:12, 24, 36, 48, 72 hour after surgery
|
PONV scores (assessed using a 0 - 2 categorical scale; no nausea/ nausea/ vomiting)
|
12, 24, 36, 48, 72 hour after surgery
|
|
Occurrence of prolonged post-operative ileus
時間枠:8 weeks after surgery
|
Occurrence of prolonged post-operative ileus (assessed using a 0 - 1 categorical scale; no ileus/ileus)
|
8 weeks after surgery
|
協力者と研究者
捜査官
- 主任研究者:Soo Yeun Park, MD、Kyungpook National University Chilgok Hospital
- 主任研究者:Corrado Pedrazzani, MD、University of Verona Hospital Trust and Colorectal Cancer Center
出版物と役立つリンク
一般刊行物
- Pedrazzani C, Park SY, Conti C, Turri G, Park JS, Kim HJ, Polati E, Guglielmi A, Choi GS. Analgesic efficacy of pre-emptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: results from a randomized, multicenter, single-blind, non-inferiority trial. Surg Endosc. 2021 Jul;35(7):3329-3338. doi: 10.1007/s00464-020-07771-6. Epub 2020 Jul 6.
- Pedrazzani C, Park SY, Scotton G, Park JS, Kim HJ, Polati E, Guglielmi A, Choi GS. Analgesic efficacy of preemptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: study protocol for a randomized, multicenter, single-blind, noninferiority trial. Trials. 2019 Jul 2;20(1):391. doi: 10.1186/s13063-019-3509-y.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。