STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy

Sponsor

Helsinki University Central Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06123117

Collaborator

(none)

850

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cholelithiasis Cholecystitis Gallbladder Cancer	Procedure: single transversus abdominis laparoscopy-guided plane block Procedure: local trocar site ropivacaine infiltration	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

850 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients are analyzed following the intention to treat in three subgroups: Patients treated in "day-care" outpatient surgical unit (DS): TAP+local vs local. Patients treated electively in the inpatient surgery unit (IS): TAP+local vs local. Emergency surgery patients (ES): TAP+local vs local.Patients are analyzed following the intention to treat in three subgroups:Patients treated in "day-care" outpatient surgical unit (DS): TAP+local vs local. Patients treated electively in the inpatient surgery unit (IS): TAP+local vs local. Emergency surgery patients (ES): TAP+local vs local.

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.

Primary Purpose:

Supportive Care

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.

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

Oct 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Daycare: STALL Local ropivacaine infiltration + laparoscopically controlled TAP (transversus abdominis plane block). Daycare patients.	Procedure: single transversus abdominis laparoscopy-guided plane block please see arm/group descriptions Other Names: STALL Procedure: local trocar site ropivacaine infiltration please see arm/group descriptions
Active Comparator: Daycare: local only Local ropivacaine infiltration only. Daycare patients.	Procedure: local trocar site ropivacaine infiltration please see arm/group descriptions
Experimental: In-patient: STALL Local ropivacaine infiltration + laparoscopically controlled TAP. In-patient surgery.	Procedure: single transversus abdominis laparoscopy-guided plane block please see arm/group descriptions Other Names: STALL Procedure: local trocar site ropivacaine infiltration please see arm/group descriptions
Active Comparator: In-patient: local only Local ropivacaine infiltration only. In-patient surgery.	Procedure: local trocar site ropivacaine infiltration please see arm/group descriptions
Experimental: Emergency: STALL Local ropivacaine infiltration + laparoscopically controlled TAP. Emergency patients.	Procedure: single transversus abdominis laparoscopy-guided plane block please see arm/group descriptions Other Names: STALL Procedure: local trocar site ropivacaine infiltration please see arm/group descriptions
Active Comparator: Emergency: local only Local ropivacaine infiltration only. Emergency patients.	Procedure: local trocar site ropivacaine infiltration please see arm/group descriptions

Outcome Measures

Primary Outcome Measures

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

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
cumulative opioid consumption (emergency and inpatient surgery) [while admitted; est. 2 days]
mg, morphine equivalent

Other Outcome Measures

maximum NRS score during the stay at the recovery [until the patient is either discharged to ward or home (day surgery patients), est. 1-4 hours]
0-10
average NRS score during the stay at the recovery [duration of stay at the recovery, est. 1-4 hours]
0-10
NRS score in multiple time points [every hour until discharge and at discharge = "ready to go" / "ready for transfer" (during in-hospital care), est. 48 hours]
if awake
procedure time [minutes; est. 60 - 180 minutes]
min
time necessary in recovery room [minutes; est. 60 - 260 min]
min, (= "patient ready to be discharged" timestamp OR "patient ready for transfer")
complications related to the use of local anesthetics [est. 0 - 7 days]
TAP + port site infiltration complications (as per trial plan) + other complications according to Clavien-Dindo classification
patient general satisfaction with pain management [prespecified: about 4 hours, 2 days, 7 days, 30 days]
using questionnaires, multiple timepoints: recovery stay, hospital stay, discharge, feedback after 7 days
time from surgery to discharge [est. 2 - 48 hours]
min
number of patients contacting the hospital regarding inadequate pain management [after discharge and before day 30]
n
prevalence of postoperative nausea and vomiting (PONV) and difference in subgroups [est. 0 - 4 (8) hours]
n; %
difference in NRS (if any) between patients received remifentanil or fentanyl intraoperatively [0 - 4 hours]
delta
difference in NRS (if any) between patients received propofol or sevoflurane maintenance. [0- 4 hours]
delta
pain-control failure & possible causes [acute: 0 - 2 days; chronic: t+30 days]
APS (acute pain service) contact, admission of DS subgroup patient to the ward due to pain, failure to discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.