STALL vs eneste lokal sårinfiltration i laparoskopisk kolecystektomi - dobbeltblindet randomiseret kontrolleret forsøg (STALL)
30. september 2026 opdateret af: Roman Kornosev, Helsinki University Central Hospital
Enkelt transversus abdominis Laparoskopi-guidet plan blok kombineret med lokal trocar site ropivacaine infiltration (STALL) vs Sole Local Wound Infiltration i LCC (Laparoscopic CholeCystektomi) - Dobbeltblindet randomiseret kontrolleret forsøg.
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.
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
850
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Roman Kornõšev, MD
- Telefonnummer: +358 504 279755
- E-mail: roman.kornosev@hus.fi
Undersøgelse Kontakt Backup
- Navn: Alexey Schramko, MD, PhD, Doc
- Telefonnummer: +358 504 270610
- E-mail: alexey.schramko@hus.fi
Studiesteder
-
-
Uusimaa
-
Espoo, Uusimaa, Finland, 00029
- Rekruttering
- Jorvi hospital / HUS
-
Kontakt:
- Roman Kornõšev
- Telefonnummer: +358504279755
- E-mail: roman.kornosev@hus.fi
-
Kontakt:
- Alexey Schramko, PhD, Doc
- Telefonnummer: +358504270610
- E-mail: alexey.schramko@hus.fi
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Daycare: STALL
Local ropivacaine infiltration + laparoscopically controlled TAP (transversus abdominis plane block). Daycare patients. |
please see arm/group descriptions
Andre navne:
please see arm/group descriptions |
|
Aktiv komparator: Daycare: local only
Local ropivacaine infiltration only. Daycare patients. |
please see arm/group descriptions |
|
Eksperimentel: In-patient: STALL
Local ropivacaine infiltration + laparoscopically controlled TAP. In-patient surgery. |
please see arm/group descriptions
Andre navne:
please see arm/group descriptions |
|
Aktiv komparator: In-patient: local only
Local ropivacaine infiltration only. In-patient surgery. |
please see arm/group descriptions |
|
Eksperimentel: Emergency: STALL
Local ropivacaine infiltration + laparoscopically controlled TAP. Emergency patients. |
please see arm/group descriptions
Andre navne:
please see arm/group descriptions |
|
Aktiv komparator: Emergency: local only
Local ropivacaine infiltration only. Emergency patients. |
please see arm/group descriptions |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
cumulative opioid consumption during the stay at the recovery
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
maximum NRS score during the day of surgery, after discharge (daycare / outpatient)
Tidsramme: 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)
Tidsramme: while admitted; est. 2 days
|
mg, morphine equivalent |
while admitted; est. 2 days
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
maximum NRS score during the stay at the recovery
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: minutes; est. 60 - 180 minutes
|
min |
minutes; est. 60 - 180 minutes
|
|
time necessary in recovery room
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: est. 2 - 48 hours
|
min |
est. 2 - 48 hours
|
|
number of patients contacting the hospital regarding inadequate pain management
Tidsramme: after discharge and before day 30
|
n |
after discharge and before day 30
|
|
prevalence of postoperative nausea and vomiting (PONV) and difference in subgroups
Tidsramme: est. 0 - 4 (8) hours
|
n; % |
est. 0 - 4 (8) hours
|
|
difference in NRS (if any) between patients received remifentanil or fentanyl intraoperatively
Tidsramme: 0 - 4 hours
|
delta |
0 - 4 hours
|
|
difference in NRS (if any) between patients received propofol or sevoflurane maintenance.
Tidsramme: 0- 4 hours
|
delta |
0- 4 hours
|
|
pain-control failure & possible causes
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studieleder: Henna Sammalkorpi, MD, PhD, Helsinki UCH
- Studieleder: Hanna Lampela, MD, PhD, Helsinki UCH
- Studieleder: Jukka Harju, MD, PhD, Doc, Helsinki UCH
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
16. januar 2024
Primær færdiggørelse (Anslået)
30. december 2026
Studieafslutning (Anslået)
30. december 2027
Datoer for studieregistrering
Først indsendt
5. november 2023
Først indsendt, der opfyldte QC-kriterier
5. november 2023
Først opslået (Faktiske)
8. november 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. oktober 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 7351
Plan for individuelle deltagerdata (IPD)
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