ClinicalTrials.gg
RecruitingNCT06123117STALLUpdated Oct 5, 2026

STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy

An interventional study of single transversus abdominis laparoscopy-guided plane block and local trocar site ropivacaine infiltration in Cholelithiasis, Cholecystitis and Gallbladder Cancer, sponsored by Helsinki University Central Hospital. Recruiting at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Helsinki University Central Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Jan 2024; still recruiting 2 years 9 months later.
Updated Oct 5, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
850
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cholelithiasis
  • Cholecystitis
  • Gallbladder Cancer

Keywords

  • laparoscopic transversus abdominis plane block
03

In context

Cholelithiasis

189 studies on the registry are indexed under Cholelithiasis; 42 are open to participants now.

This study's planned enrollment of 850 is above the median of 90 across 135 interventional studies indexed under Cholelithiasis.

Browse Cholelithiasis studies →

Lead sponsor

Helsinki University Central Hospital is the lead sponsor of 311 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 for whatever reason.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
850 participants (estimated)

Study arms

  • Experimental
    Daycare: STALL

    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

  • Active comparator
    Daycare: local only

    Local ropivacaine infiltration only. Daycare patients.

    Procedure: local trocar site ropivacaine infiltration

  • Experimental
    In-patient: STALL

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

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

  • Active comparator
    In-patient: local only

    Local ropivacaine infiltration only. In-patient surgery.

    Procedure: local trocar site ropivacaine infiltration

  • Experimental
    Emergency: STALL

    Local ropivacaine infiltration + laparoscopically controlled TAP. Emergency patients.

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

  • Active comparator
    Emergency: local only

    Local ropivacaine infiltration only. Emergency patients.

    Procedure: local trocar site ropivacaine infiltration

Interventions

  • Proceduresingle transversus abdominis laparoscopy-guided plane block

    please see arm/group descriptions

    Also known as: STALL

  • Procedurelocal trocar site ropivacaine infiltration

    please see arm/group descriptions

06

What researchers measure

Primary outcomes

  1. cumulative opioid consumption during the stay at the recovery

    all groups; mg, morphine equivalent

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

Secondary outcomes

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

    NRS (Numerical Rating Scale): 0-10

    Time frame: 30 min after surgery, every 60 min afterwards; 2 days

  2. cumulative opioid consumption (emergency and inpatient surgery)

    mg, morphine equivalent

    Time frame: while admitted; est. 2 days

Other outcomes

  1. maximum NRS score during the stay at the recovery

    0-10

    Time frame: until the patient is either discharged to ward or home (day surgery patients), est. 1-4 hours

  2. average NRS score during the stay at the recovery

    0-10

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

  3. NRS score in multiple time points

    if awake

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

  4. procedure time

    min

    Time frame: minutes; est. 60 - 180 minutes

  5. time necessary in recovery room

    min, (= "patient ready to be discharged" timestamp OR "patient ready for transfer")

    Time frame: minutes; est. 60 - 260 min

  6. complications related to the use of local anesthetics

    TAP + port site infiltration complications (as per trial plan) + other complications according to Clavien-Dindo classification

    Time frame: est. 0 - 7 days

  7. patient general satisfaction with pain management

    using questionnaires, multiple timepoints: recovery stay, hospital stay, discharge, feedback after 7 days

    Time frame: prespecified: about 4 hours, 2 days, 7 days, 30 days

  8. time from surgery to discharge

    min

    Time frame: est. 2 - 48 hours

  9. number of patients contacting the hospital regarding inadequate pain management

    n

    Time frame: after discharge and before day 30

  10. prevalence of postoperative nausea and vomiting (PONV) and difference in subgroups

    n; %

    Time frame: est. 0 - 4 (8) hours

  11. difference in NRS (if any) between patients received remifentanil or fentanyl intraoperatively

    delta

    Time frame: 0 - 4 hours

  12. difference in NRS (if any) between patients received propofol or sevoflurane maintenance.

    delta

    Time frame: 0- 4 hours

  13. pain-control failure & possible causes

    APS (acute pain service) contact, admission of DS subgroup patient to the ward due to pain, failure to discharge

    Time frame: acute: 0 - 2 days; chronic: t+30 days

07

Study locations

1 of 1 sites recruiting
  • Jorvi hospital / HUS
    Espoo, Uusimaa 00029, Finland
    Recruiting
08

References and documents

Publications

  • 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. PubMed 29943054 ↗
  • 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. PubMed 34480217 ↗
  • 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. PubMed 29980989 ↗
  • 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. PubMed 26885872 ↗
  • 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. PubMed 28913472 ↗
  • 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. PubMed 24619479 ↗
  • 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. PubMed 25899736 ↗
  • 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. PubMed 22869941 ↗
  • 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. PubMed 22330261 ↗
  • 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. PubMed 27746552 ↗
  • 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. PubMed 28472015 ↗
  • 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. PubMed 30342470 ↗
  • 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. PubMed 29214081 ↗

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Primary completion
Dec 2025→Dec 30, 2026
Oct 5, 2026
Study completion
Oct 2027→Dec 30, 2027
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Primary completion Dec 2025→Dec 30, 2026
    Study completion Oct 2027→Dec 30, 2027
    + 2 other changes: verification date and oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06123117
Responsible party
Roman Kornosev (MD, Helsinki University Central Hospital) — Principal investigator
First posted
Nov 8, 2023
Start date
Jan 16, 2024
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Oct 5, 2026

Study contacts

Roman Kornõšev, MD
Contact
roman.kornosev@hus.fi
+358 504 279755
Alexey Schramko, MD, PhD, Doc
Contact
alexey.schramko@hus.fi
+358 504 270610
Henna Sammalkorpi, MD, PhD
study director · Helsinki UCH
Hanna Lampela, MD, PhD
study director · Helsinki UCH
Jukka Harju, MD, PhD, Doc
study director · Helsinki UCH

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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