Clinical trial NCT06123117: STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cholelithiasis
Cholecystitis
Gallbladder Cancer
Keywords: laparoscopic transversus abdominis plane block
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.


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.

Primary outcomes:
measure: cumulative opioid consumption during the stay at the recovery
timeFrame: duration of stay at the recovery (estimated 1-4 hours)
Secondary outcomes:
measure: maximum NRS score during the day of surgery, after discharge (daycare / outpatient)
timeFrame: 30 min after surgery, every 60 min afterwards; 2 days
measure: cumulative opioid consumption (emergency and inpatient surgery)
timeFrame: while admitted; est. 2 days
Other outcomes:
measure: maximum NRS score during the stay at the recovery
timeFrame: until the patient is either discharged to ward or home (day surgery patients), est. 1-4 hours
measure: average NRS score during the stay at the recovery
timeFrame: duration of stay at the recovery, est. 1-4 hours
measure: NRS score in multiple time points
timeFrame: every hour until discharge and at discharge = "ready to go" / "ready for transfer" (during in-hospital care), est. 48 hours
measure: procedure time
timeFrame: minutes; est. 60 - 180 minutes
measure: time necessary in recovery room
timeFrame: minutes; est. 60 - 260 min
measure: complications related to the use of local anesthetics
timeFrame: est. 0 - 7 days
measure: patient general satisfaction with pain management
timeFrame: prespecified: about 4 hours, 2 days, 7 days, 30 days
measure: time from surgery to discharge
timeFrame: est. 2 - 48 hours
measure: number of patients contacting the hospital regarding inadequate pain management
timeFrame: after discharge and before day 30
measure: prevalence of postoperative nausea and vomiting (PONV) and difference in subgroups
timeFrame: est. 0 - 4 (8) hours
measure: difference in NRS (if any) between patients received remifentanil or fentanyl intraoperatively
timeFrame: 0 - 4 hours
measure: difference in NRS (if any) between patients received propofol or sevoflurane maintenance.
timeFrame: 0- 4 hours
measure: pain-control failure & possible causes
timeFrame: acute: 0 - 2 days; chronic: t+30 days
Locations:
city: Espoo
country: Finland
facility: Jorvi hospital / HUS
state: Uusimaa
Study officials:
affiliation: Helsinki UCH
name: Henna Sammalkorpi, MD, PhD
role: STUDY_DIRECTOR
affiliation: Helsinki UCH
name: Hanna Lampela, MD, PhD
role: STUDY_DIRECTOR
affiliation: Helsinki UCH
name: Jukka Harju, MD, PhD, Doc
role: STUDY_DIRECTOR
References:
citation: Siriwardana RC, Kumarage SK, Gunathilake BM, Thilakarathne SB, Wijesinghe JS. Local infiltration versus laparoscopic-guided transverse abdominis plane block in laparoscopic cholecystectomy: double-blinded randomized control trial. Surg Endosc. 2019 Jan;33(1):179-183. doi: 10.1007/s00464-018-6291-0. Epub 2018 Jun 25.
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