STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy

NCT06123117 | Recruiting

• 1 other identifier: 7351
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cholelithiasis; Cholecystitis; Gallbladder Cancer

Keywords

laparoscopic transversus abdominis plane block

Outcome Measures

Primary Outcomes (1)

• cumulative opioid consumption during the stay at the recovery

  all groups; mg, morphine equivalent

  duration of stay at the recovery (estimated 1-4 hours)

Secondary Outcomes (2)

• maximum NRS score during the day of surgery, after discharge (daycare / outpatient)

  30 min after surgery, every 60 min afterwards; 2 days

• cumulative opioid consumption (emergency and inpatient surgery)

  while admitted; est. 2 days

Other Outcomes (13)

• maximum NRS score during the stay at the recovery

  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

  duration of stay at the recovery, est. 1-4 hours

• NRS score in multiple time points

  every hour until discharge and at discharge = "ready to go" / "ready for transfer" (during in-hospital care), est. 48 hours

Study Arms (6)

Daycare: STALL

EXPERIMENTAL

Local ropivacaine infiltration + laparoscopically controlled TAP (transversus abdominis plane block). Daycare patients.

Procedure: single transversus abdominis laparoscopy-guided plane block; Procedure: local trocar site ropivacaine infiltration

Daycare: local only

ACTIVE COMPARATOR

Local ropivacaine infiltration only. Daycare patients.

Procedure: local trocar site ropivacaine infiltration

In-patient: STALL

EXPERIMENTAL

Local ropivacaine infiltration + laparoscopically controlled TAP. In-patient surgery.

Procedure: single transversus abdominis laparoscopy-guided plane block; Procedure: local trocar site ropivacaine infiltration

In-patient: local only

ACTIVE COMPARATOR

Local ropivacaine infiltration only. In-patient surgery.

Procedure: local trocar site ropivacaine infiltration

Emergency: STALL

EXPERIMENTAL

Local ropivacaine infiltration + laparoscopically controlled TAP. Emergency patients.

Procedure: single transversus abdominis laparoscopy-guided plane block; Procedure: local trocar site ropivacaine infiltration

Emergency: local only

ACTIVE COMPARATOR

Local ropivacaine infiltration only. Emergency patients.

Procedure: local trocar site ropivacaine infiltration

Interventions

single transversus abdominis laparoscopy-guided plane block PROCEDURE

please see arm/group descriptions

Also known as: STALL

Daycare: STALL; Emergency: STALL; In-patient: STALL

local trocar site ropivacaine infiltration PROCEDURE

please see arm/group descriptions

Daycare: STALL; Daycare: local only; Emergency: STALL; Emergency: local only; In-patient: STALL; In-patient: local only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients scheduled for elective or emergency LCC, aged over 18 and able to give an informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Jorvi hospital / HUS

Espoo, Uusimaa, 00029, Finland

RECRUITING

Related Publications (13)

• 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.

  PMID: 29943054 BACKGROUND

• 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.

  PMID: 34480217 BACKGROUND

• 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.

  PMID: 29980989 BACKGROUND

• 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.

  PMID: 26885872 BACKGROUND

• 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.

  PMID: 28913472 BACKGROUND

• 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.

  PMID: 24619479 BACKGROUND

• 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.

  PMID: 25899736 BACKGROUND

• 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.

  PMID: 22869941 BACKGROUND

• 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.

  PMID: 22330261 BACKGROUND

• 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.

  PMID: 27746552 BACKGROUND

• 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.

  PMID: 28472015 BACKGROUND

• 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.

  PMID: 30342470 BACKGROUND

• 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.

  PMID: 29214081 BACKGROUND

MeSH Terms

Conditions

Cholelithiasis; Cholecystitis; Gallbladder Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Henna Sammalkorpi, MD, PhD

  Helsinki UCH

  STUDY DIRECTOR

• Hanna Lampela, MD, PhD

  Helsinki UCH

  STUDY DIRECTOR

• Jukka Harju, MD, PhD, Doc

  Helsinki UCH

  STUDY DIRECTOR

Central Study Contacts

Roman Kornõšev, MD

CONTACT

+358 504 279755; roman.kornosev@hus.fi

Alexey Schramko, MD, PhD, Doc

CONTACT

+358 504 270610; alexey.schramko@hus.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be blinded to patients and recovery room personnel, as well as the ward nurses and physicians, but not to operating surgeon(s), anesthesiologist(s), and nurses, treating patients during the surgery.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Patients are analyzed following the intention to treat in three subgroups: 1. Patients treated in "day-care" outpatient surgical unit (DS): TAP+local vs local. 2. Patients treated electively in the inpatient surgery unit (IS): TAP+local vs local. 3. Emergency surgery patients (ES): TAP+local vs local.

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: November 8, 2023
• Study Start: January 16, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)