STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHelsinki University Central Hospital
About this 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.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients scheduled for elective or emergency LCC, aged over 18 and able to give an informed consent.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
single transversus abdominis laparoscopy-guided plane block
Procedure/Surgeryplease see arm/group descriptions
local trocar site ropivacaine infiltration
Procedure/Surgeryplease see arm/group descriptions
Treatment groups
850 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Daycare: STALLExperimental treatment 2 interventions
Group B: Daycare: local onlyActive comparator 1 intervention
Group C: In-patient: STALLExperimental treatment 2 interventions
Group D: In-patient: local onlyActive comparator 1 intervention
Group E: Emergency: STALLExperimental treatment 2 interventions
Group F: Emergency: local onlyActive comparator 1 intervention
Trial outcomes
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 days2
cumulative opioid consumption (emergency and inpatient surgery)
mg, morphine equivalent
Time frame
while admitted; est. 2 daysOther 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 hours2
average NRS score during the stay at the recovery
0-10
Time frame
duration of stay at the recovery, est. 1-4 hours3
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 hours4
procedure time
min
Time frame
minutes; est. 60 - 180 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov