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Trial Title:
STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy
NCT ID:
NCT06123117
Condition:
Cholelithiasis
Cholecystitis
Gallbladder Cancer
Conditions: Official terms:
Gallbladder Neoplasms
Cholecystitis
Cholelithiasis
Cholecystolithiasis
Gallstones
Ropivacaine
Conditions: Keywords:
laparoscopic transversus abdominis plane block
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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.
Primary purpose:
Supportive Care
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description:
The study will be blinded to patients and recovery room personnel, as well as the ward
nurses and physicians, but not to operating surgeon(s), anesthesiologist(s), and nurses,
treating patients during the surgery.
Intervention:
Intervention type:
Procedure
Intervention name:
single transversus abdominis laparoscopy-guided plane block
Description:
please see arm/group descriptions
Arm group label:
Daycare: STALL
Arm group label:
Emergency: STALL
Arm group label:
In-patient: STALL
Other name:
STALL
Intervention type:
Procedure
Intervention name:
local trocar site ropivacaine infiltration
Description:
please see arm/group descriptions
Arm group label:
Daycare: STALL
Arm group label:
Daycare: local only
Arm group label:
Emergency: STALL
Arm group label:
Emergency: local only
Arm group label:
In-patient: STALL
Arm group label:
In-patient: local only
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- All patients scheduled for elective or emergency LCC, aged over 18 and able to give
an informed consent.
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 informed consent for whatever
reason.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Jorvi hospital / HUS
Address:
City:
Espoo
Zip:
02740
Country:
Finland
Status:
Recruiting
Contact:
Last name:
Roman Kornõšev
Phone:
+358504279755
Email:
roman.kornosev@hus.fi
Contact backup:
Last name:
Alexey Schramko, PhD, Doc
Phone:
+358504270610
Email:
alexey.schramko@hus.fi
Start date:
January 16, 2024
Completion date:
October 2027
Lead sponsor:
Agency:
Helsinki University Central Hospital
Agency class:
Other
Source:
Helsinki University Central Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06123117
