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
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.
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 →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.
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.
Exclusion Criteria:
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Local ropivacaine infiltration only. Daycare patients.
Procedure: local trocar site ropivacaine infiltration
Local ropivacaine infiltration + laparoscopically controlled TAP. In-patient surgery.
Procedure: single transversus abdominis laparoscopy-guided plane block · Procedure: local trocar site ropivacaine infiltration
Local ropivacaine infiltration only. In-patient surgery.
Procedure: local trocar site ropivacaine infiltration
Local ropivacaine infiltration + laparoscopically controlled TAP. Emergency patients.
Procedure: single transversus abdominis laparoscopy-guided plane block · Procedure: local trocar site ropivacaine infiltration
Local ropivacaine infiltration only. Emergency patients.
Procedure: local trocar site ropivacaine infiltration
please see arm/group descriptions
Also known as: STALL
please see arm/group descriptions
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)
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
cumulative opioid consumption (emergency and inpatient surgery)
mg, morphine equivalent
Time frame: while admitted; est. 2 days
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
average NRS score during the stay at the recovery
0-10
Time frame: duration of stay at the recovery, est. 1-4 hours
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
procedure time
min
Time frame: minutes; est. 60 - 180 minutes
time necessary in recovery room
min, (= "patient ready to be discharged" timestamp OR "patient ready for transfer")
Time frame: minutes; est. 60 - 260 min
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
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
time from surgery to discharge
min
Time frame: est. 2 - 48 hours
number of patients contacting the hospital regarding inadequate pain management
n
Time frame: after discharge and before day 30
prevalence of postoperative nausea and vomiting (PONV) and difference in subgroups
n; %
Time frame: est. 0 - 4 (8) hours
difference in NRS (if any) between patients received remifentanil or fentanyl intraoperatively
delta
Time frame: 0 - 4 hours
difference in NRS (if any) between patients received propofol or sevoflurane maintenance.
delta
Time frame: 0- 4 hours
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
Plan to share: No
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 ↗
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