복강경 담낭 절제술에서 STALL 대 단독 국소 상처 침윤 - 이중 맹검 무작위 대조 시험 (STALL)
단일 복강경 복강경 검사 유도 평면 블록과 국소 투관침 부위 로피바카인 침윤(STALL) 대 LCC(복강경 담낭절제술)의 단독 국소 상처 침윤 - 이중 맹검 무작위 대조 시험.
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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Roman Kornõšev, MD
- 전화번호: +358 504 279755
- 이메일: roman.kornosev@hus.fi
연구 연락처 백업
- 이름: Alexey Schramko, MD, PhD, Doc
- 전화번호: +358 504 270610
- 이메일: alexey.schramko@hus.fi
연구 장소
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Uusimaa
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Espoo, Uusimaa, 핀란드, 00029
- 모병
- Jorvi hospital / HUS
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연락하다:
- Roman Kornõšev
- 전화번호: +358504279755
- 이메일: roman.kornosev@hus.fi
-
연락하다:
- Alexey Schramko, PhD, Doc
- 전화번호: +358504270610
- 이메일: alexey.schramko@hus.fi
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Daycare: STALL
Local ropivacaine infiltration + laparoscopically controlled TAP (transversus abdominis plane block). Daycare patients. |
please see arm/group descriptions
다른 이름들:
please see arm/group descriptions |
|
활성 비교기: Daycare: local only
Local ropivacaine infiltration only. Daycare patients. |
please see arm/group descriptions |
|
실험적: In-patient: STALL
Local ropivacaine infiltration + laparoscopically controlled TAP. In-patient surgery. |
please see arm/group descriptions
다른 이름들:
please see arm/group descriptions |
|
활성 비교기: In-patient: local only
Local ropivacaine infiltration only. In-patient surgery. |
please see arm/group descriptions |
|
실험적: Emergency: STALL
Local ropivacaine infiltration + laparoscopically controlled TAP. Emergency patients. |
please see arm/group descriptions
다른 이름들:
please see arm/group descriptions |
|
활성 비교기: Emergency: local only
Local ropivacaine infiltration only. Emergency patients. |
please see arm/group descriptions |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
cumulative opioid consumption during the stay at the recovery
기간: 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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
maximum NRS score during the day of surgery, after discharge (daycare / outpatient)
기간: 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)
기간: while admitted; est. 2 days
|
mg, morphine equivalent |
while admitted; est. 2 days
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
maximum NRS score during the stay at the recovery
기간: 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
기간: 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
기간: 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
기간: minutes; est. 60 - 180 minutes
|
min |
minutes; est. 60 - 180 minutes
|
|
time necessary in recovery room
기간: 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
기간: 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
기간: 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
기간: est. 2 - 48 hours
|
min |
est. 2 - 48 hours
|
|
number of patients contacting the hospital regarding inadequate pain management
기간: after discharge and before day 30
|
n |
after discharge and before day 30
|
|
prevalence of postoperative nausea and vomiting (PONV) and difference in subgroups
기간: est. 0 - 4 (8) hours
|
n; % |
est. 0 - 4 (8) hours
|
|
difference in NRS (if any) between patients received remifentanil or fentanyl intraoperatively
기간: 0 - 4 hours
|
delta |
0 - 4 hours
|
|
difference in NRS (if any) between patients received propofol or sevoflurane maintenance.
기간: 0- 4 hours
|
delta |
0- 4 hours
|
|
pain-control failure & possible causes
기간: 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
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Henna Sammalkorpi, MD, PhD, Helsinki UCH
- 연구 책임자: Hanna Lampela, MD, PhD, Helsinki UCH
- 연구 책임자: Jukka Harju, MD, PhD, Doc, Helsinki UCH
간행물 및 유용한 링크
일반 간행물
- 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.
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
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