腹腔鏡下胆嚢摘出術における STALL 対 唯一の局所創傷浸潤 - 二重盲検ランダム化対照試験 (STALL)
LCC（腹腔鏡下胆嚢摘出術）における局所トロカール部位ロピバカイン浸潤（STALL）と唯一の局所創傷浸潤を組み合わせた単回腹横筋腹腔鏡ガイド下平面ブロック - 二重盲検ランダム化対照試験。
This trial is a prospective randomized superiority trial comparing sole ropivacaine based local trocar site infiltration to local infiltration combined with laparoscopic ropivacaine TAP block (STALL) in LCC.
There are only a few randomized trials comparing sole local anesthesia to additional laparoscopic TAP block in laparoscopic cholecystectomy and they have yet failed to show evidence in favor of TAP block.
We hypothesize STALL (Single Transversus Abdominis Laparoscopy-guided plane block combined with Local trocar site ropivacaine infiltration) is superior to local port site infiltration, provided that the sample size is sufficiently big.
The aim of this randomized study is to compare the efficacy of sole local anesthesia of trocar sites to STALL in LCC.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Roman Kornõšev, MD
- 電話番号：+358 504 279755
- メール：roman.kornosev@hus.fi
研究連絡先のバックアップ
- 名前：Alexey Schramko, MD, PhD, Doc
- 電話番号：+358 504 270610
- メール：alexey.schramko@hus.fi
研究場所
-
-
Uusimaa
-
Espoo、Uusimaa、フィンランド、00029
- 募集
- Jorvi hospital / HUS
-
コンタクト：
- Roman Kornõšev
- 電話番号：+358504279755
- メール：roman.kornosev@hus.fi
-
コンタクト：
- Alexey Schramko, PhD, Doc
- 電話番号：+358504270610
- メール：alexey.schramko@hus.fi
-
-
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:
- All patients scheduled for elective or emergency LCC, aged over 18 and able to give an informed consent.
Exclusion Criteria:
- Age under 18 years, chronic daily opioid and/or pain tolerance / pain threshold -modifying medication use (abuse), pregnancy, known allergy to local anesthetics, diagnosed severe coagulopathy and incapability to give informed consent for whatever reason.
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：支持療法
- 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：Daycare: STALL
Local ropivacaine infiltration + laparoscopically controlled TAP (transversus abdominis plane block). Daycare patients. |
please see arm/group descriptions
他の名前：
please see arm/group descriptions |
|
アクティブコンパレータ：Daycare: local only
Local ropivacaine infiltration only. Daycare patients. |
please see arm/group descriptions |
|
実験的：In-patient: STALL
Local ropivacaine infiltration + laparoscopically controlled TAP. In-patient surgery. |
please see arm/group descriptions
他の名前：
please see arm/group descriptions |
|
アクティブコンパレータ：In-patient: local only
Local ropivacaine infiltration only. In-patient surgery. |
please see arm/group descriptions |
|
実験的：Emergency: STALL
Local ropivacaine infiltration + laparoscopically controlled TAP. Emergency patients. |
please see arm/group descriptions
他の名前：
please see arm/group descriptions |
|
アクティブコンパレータ：Emergency: local only
Local ropivacaine infiltration only. Emergency patients. |
please see arm/group descriptions |
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 |
|---|---|---|
|
cumulative opioid consumption during the stay at the recovery
時間枠：duration of stay at the recovery (estimated 1-4 hours)
|
all groups; mg, morphine equivalent |
duration of stay at the recovery (estimated 1-4 hours)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
maximum NRS score during the day of surgery, after discharge (daycare / outpatient)
時間枠：30 min after surgery, every 60 min afterwards; 2 days
|
NRS (Numerical Rating Scale): 0-10 |
30 min after surgery, every 60 min afterwards; 2 days
|
|
cumulative opioid consumption (emergency and inpatient surgery)
時間枠：while admitted; est. 2 days
|
mg, morphine equivalent |
while admitted; est. 2 days
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
maximum NRS score during the stay at the recovery
時間枠：until the patient is either discharged to ward or home (day surgery patients), est. 1-4 hours
|
0-10 |
until the patient is either discharged to ward or home (day surgery patients), est. 1-4 hours
|
|
average NRS score during the stay at the recovery
時間枠：duration of stay at the recovery, est. 1-4 hours
|
0-10 |
duration of stay at the recovery, est. 1-4 hours
|
|
NRS score in multiple time points
時間枠：every hour until discharge and at discharge = "ready to go" / "ready for transfer" (during in-hospital care), est. 48 hours
|
if awake |
every hour until discharge and at discharge = "ready to go" / "ready for transfer" (during in-hospital care), est. 48 hours
|
|
procedure time
時間枠：minutes; est. 60 - 180 minutes
|
min |
minutes; est. 60 - 180 minutes
|
|
time necessary in recovery room
時間枠：minutes; est. 60 - 260 min
|
min, (= "patient ready to be discharged" timestamp OR "patient ready for transfer") |
minutes; est. 60 - 260 min
|
|
complications related to the use of local anesthetics
時間枠：est. 0 - 7 days
|
TAP + port site infiltration complications (as per trial plan) + other complications according to Clavien-Dindo classification |
est. 0 - 7 days
|
|
patient general satisfaction with pain management
時間枠：prespecified: about 4 hours, 2 days, 7 days, 30 days
|
using questionnaires, multiple timepoints: recovery stay, hospital stay, discharge, feedback after 7 days |
prespecified: about 4 hours, 2 days, 7 days, 30 days
|
|
time from surgery to discharge
時間枠：est. 2 - 48 hours
|
min |
est. 2 - 48 hours
|
|
number of patients contacting the hospital regarding inadequate pain management
時間枠：after discharge and before day 30
|
n |
after discharge and before day 30
|
|
prevalence of postoperative nausea and vomiting (PONV) and difference in subgroups
時間枠：est. 0 - 4 (8) hours
|
n; % |
est. 0 - 4 (8) hours
|
|
difference in NRS (if any) between patients received remifentanil or fentanyl intraoperatively
時間枠：0 - 4 hours
|
delta |
0 - 4 hours
|
|
difference in NRS (if any) between patients received propofol or sevoflurane maintenance.
時間枠：0- 4 hours
|
delta |
0- 4 hours
|
|
pain-control failure & possible causes
時間枠：acute: 0 - 2 days; chronic: t+30 days
|
APS (acute pain service) contact, admission of DS subgroup patient to the ward due to pain, failure to discharge |
acute: 0 - 2 days; chronic: t+30 days
|
協力者と研究者
捜査官
- スタディディレクター：Henna Sammalkorpi, MD, PhD、Helsinki UCH
- スタディディレクター：Hanna Lampela, MD, PhD、Helsinki UCH
- スタディディレクター：Jukka Harju, MD, PhD, Doc、Helsinki UCH
出版物と役立つリンク
一般刊行物
- Elamin G, Waters PS, Hamid H, O'Keeffe HM, Waldron RM, Duggan M, Khan W, Barry MK, Khan IZ. Efficacy of a Laparoscopically Delivered Transversus Abdominis Plane Block Technique during Elective Laparoscopic Cholecystectomy: A Prospective, Double-Blind Randomized Trial. J Am Coll Surg. 2015 Aug;221(2):335-44. doi: 10.1016/j.jamcollsurg.2015.03.030. Epub 2015 Mar 27.
- Ravichandran NT, Sistla SC, Kundra P, Ali SM, Dhanapal B, Galidevara I. Laparoscopic-assisted Tranversus Abdominis Plane (TAP) Block Versus Ultrasonography-guided Transversus Abdominis Plane Block in Postlaparoscopic Cholecystectomy Pain Relief: Randomized Controlled Trial. Surg Laparosc Endosc Percutan Tech. 2017 Aug;27(4):228-232. doi: 10.1097/SLE.0000000000000405.
- Siriwardana RC, Kumarage SK, Gunathilake BM, Thilakarathne SB, Wijesinghe JS. Local infiltration versus laparoscopic-guided transverse abdominis plane block in laparoscopic cholecystectomy: double-blinded randomized control trial. Surg Endosc. 2019 Jan;33(1):179-183. doi: 10.1007/s00464-018-6291-0. Epub 2018 Jun 25.
- Bumblyte V, Rasilainen SK, Ehrlich A, Scheinin T, Kontinen VK, Sevon A, Vaaraniemi H, Schramko AA. Purely ropivacaine-based TEA vs single TAP block in pain management after elective laparoscopic colon surgery within an upgraded institutional ERAS program. Surg Endosc. 2022 May;36(5):3323-3331. doi: 10.1007/s00464-021-08647-z. Epub 2021 Sep 3.
- Ruiz-Tovar J, Garcia A, Ferrigni C, Gonzalez J, Levano-Linares C, Jimenez-Fuertes M, Llavero C, Duran M. Laparoscopic-Guided Transversus Abdominis Plane (TAP) Block as Part of Multimodal Analgesia in Laparoscopic Roux-en-Y Gastric Bypass Within an Enhanced Recovery After Surgery (ERAS) Program: a Prospective Randomized Clinical Trial. Obes Surg. 2018 Nov;28(11):3374-3379. doi: 10.1007/s11695-018-3376-8.
- Peng K, Ji FH, Liu HY, Wu SR. Ultrasound-Guided Transversus Abdominis Plane Block for Analgesia in Laparoscopic Cholecystectomy: A Systematic Review and Meta-Analysis. Med Princ Pract. 2016;25(3):237-46. doi: 10.1159/000444688. Epub 2016 Feb 16.
- Breazu CM, Ciobanu L, Hadade A, Bartos A, Mitre C, Mircea PA, Ionescu D. The efficacy of oblique subcostal transversus abdominis plane block in laparoscopic cholecystectomy - a prospective, placebo controlled study. Rom J Anaesth Intensive Care. 2016 Apr;23(1):12-18. doi: 10.21454/rjaic.7518.231.obq.
- Tolchard S, Davies R, Martindale S. Efficacy of the subcostal transversus abdominis plane block in laparoscopic cholecystectomy: Comparison with conventional port-site infiltration. J Anaesthesiol Clin Pharmacol. 2012 Jul;28(3):339-43. doi: 10.4103/0970-9185.98331.
- Ortiz J, Suliburk JW, Wu K, Bailard NS, Mason C, Minard CG, Palvadi RR. Bilateral transversus abdominis plane block does not decrease postoperative pain after laparoscopic cholecystectomy when compared with local anesthetic infiltration of trocar insertion sites. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):188-92. doi: 10.1097/AAP.0b013e318244851b.
- Bava EP, Ramachandran R, Rewari V, Chandralekha, Bansal VK, Trikha A. Analgesic efficacy of ultrasound guided transversus abdominis plane block versus local anesthetic infiltration in adult patients undergoing single incision laparoscopic cholecystectomy: A randomized controlled trial. Anesth Essays Res. 2016 Sep-Dec;10(3):561-567. doi: 10.4103/0259-1162.186620.
- Peng W, Huang S, Zhou S, Yang N, Zuo M. Case report: life-threatening coronary artery spasm under transversus abdominis plane block in combination with general anesthesia. BMC Anesthesiol. 2018 Oct 20;18(1):148. doi: 10.1186/s12871-018-0616-3.
- Salaria ON, Kannan M, Kerner B, Goldman H. A Rare Complication of a TAP Block Performed after Caesarean Delivery. Case Rep Anesthesiol. 2017;2017:1072576. doi: 10.1155/2017/1072576. Epub 2017 Oct 29.
- Loizides S, Gurusamy KS, Nagendran M, Rossi M, Guerrini GP, Davidson BR. Wound infiltration with local anaesthetic agents for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 12;2014(3):CD007049. doi: 10.1002/14651858.CD007049.pub2.
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研究開始 (実際)
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研究の完了 (推定)
試験登録日
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QC基準を満たした最初の提出物
最初の投稿 (実際)
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