STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy
- Conditions
- CholelithiasisCholecystitisGallbladder Cancer
- Interventions
- Procedure: local trocar site ropivacaine infiltrationProcedure: single transversus abdominis laparoscopy-guided plane block
- Registration Number
- NCT06123117
- Lead Sponsor
- Helsinki University Central Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 850
- All patients scheduled for elective or emergency LCC, aged over 18 and able to give an informed consent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Daycare: local only local trocar site ropivacaine infiltration Local ropivacaine infiltration only. Daycare patients. Emergency: local only local trocar site ropivacaine infiltration Local ropivacaine infiltration only. Emergency patients. Daycare: STALL local trocar site ropivacaine infiltration Local ropivacaine infiltration + laparoscopically controlled TAP (transversus abdominis plane block). Daycare patients. Emergency: STALL single transversus abdominis laparoscopy-guided plane block Local ropivacaine infiltration + laparoscopically controlled TAP. Emergency patients. In-patient: STALL single transversus abdominis laparoscopy-guided plane block Local ropivacaine infiltration + laparoscopically controlled TAP. In-patient surgery. Emergency: STALL local trocar site ropivacaine infiltration Local ropivacaine infiltration + laparoscopically controlled TAP. Emergency patients. Daycare: STALL single transversus abdominis laparoscopy-guided plane block Local ropivacaine infiltration + laparoscopically controlled TAP (transversus abdominis plane block). Daycare patients. In-patient: STALL local trocar site ropivacaine infiltration Local ropivacaine infiltration + laparoscopically controlled TAP. In-patient surgery. In-patient: local only local trocar site ropivacaine infiltration Local ropivacaine infiltration only. In-patient surgery.
- Primary Outcome Measures
Name Time Method cumulative opioid consumption during the stay at the recovery duration of stay at the recovery (estimated 1-4 hours) all groups; mg, morphine equivalent
- Secondary Outcome Measures
Name Time Method cumulative opioid consumption (emergency and inpatient surgery) while admitted; est. 2 days mg, morphine equivalent
maximum NRS score during the day of surgery, after discharge (daycare / outpatient) 30 min after surgery, every 60 min afterwards; 2 days NRS (Numerical Rating Scale): 0-10
Trial Locations
- Locations (1)
Jorvi hospital / HUS
🇫🇮Espoo, Uusimaa, Finland