CholelithiasisSTALLNCT06123117
STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy
A study testing single transversus abdominis laparoscopy-guided plane block and local trocar site ropivacaine infiltration in people with Cholelithiasis and Cholecystitis, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholelithiasis, Cholecystitis, Gallbladder Cancer
- What is being tested?
- single transversus abdominis laparoscopy-guided plane block and local trocar site ropivacaine infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteFinland
- Study dates
- 16 Jan 2024to 30 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients scheduled for elective or emergency LCC, aged over 18 and able to give an informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Finland1 site, 1 recruiting
- Recruiting
Jorvi hospital / HUS
Espoo, Uusimaa, 00029
Roman Kornõšev, +358504279755, roman.kornosev@hus.fi
Alexey Schramko, PhD, Doc, +358504270610, alexey.schramko@hus.fi
About this study
Official title: Single Transversus Abdominis Laparoscopy-guided Plane Block Combined With Local Trocar Site Ropivacaine Infiltration (STALL) vs Sole Local Wound Infiltration in LCC (Laparoscopic CholeCystectomy) - Double-blinded Randomized Controlled Trial.
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.
Read more
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
- Being tested
- single transversus abdominis laparoscopy-guided plane block, local trocar site ropivacaine infiltration
- Keywords
- laparoscopic transversus abdominis plane block
- Medical subject headings
- Cholelithiasis, Cholecystitis, Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single transversus abdominis laparoscopy-guided plane blockProcedure or surgery
Also called STALL
please see arm/group descriptions
local trocar site ropivacaine infiltrationProcedure or surgery
please see arm/group descriptions
| Study group | Role | What they receive |
|---|---|---|
| Daycare: STALL | Experimental | Local ropivacaine infiltration + laparoscopically controlled TAP (transversus abdominis plane block). Daycare patients. Receives: 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. Receives: Procedure: local trocar site ropivacaine infiltration |
| In-patient: STALL | Experimental | Local ropivacaine infiltration + laparoscopically controlled TAP. In-patient surgery. Receives: 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. Receives: Procedure: local trocar site ropivacaine infiltration |
| Emergency: STALL | Experimental | Local ropivacaine infiltration + laparoscopically controlled TAP. Emergency patients. Receives: 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. Receives: Procedure: local trocar site ropivacaine infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative opioid consumption during the stay at the recovery
all groups; mg, morphine equivalent
Measured: 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)
NRS (Numerical Rating Scale): 0-10
Measured: 30 min after surgery, every 60 min afterwards; 2 days
cumulative opioid consumption (emergency and inpatient surgery)
mg, morphine equivalent
Measured: while admitted; est. 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start16 Jan 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roman Kornosev, Helsinki University Central Hospital
- Investigators
- Henna Sammalkorpi, MD, PhD, Study director, Helsinki UCHHanna Lampela, MD, PhD, Study director, Helsinki UCHJukka Harju, MD, PhD, Doc, Study director, Helsinki UCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123117
- Sponsor's protocol ID
- 7351
- Acronym
- STALL
- Status last verified
- Sep 2026
- First submitted
- 5 Nov 2023
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 29943054Bumblyte 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 34480217Ruiz-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 29980989Peng 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 26885872Breazu 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 28913472Loizides 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 24619479Elamin 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 25899736Tolchard 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 22869941Ortiz 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 22330261Bava 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 27746552Ravichandran 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 28472015Peng 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 30342470Salaria 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