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.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• All patients scheduled for elective or emergency LCC, aged over 18 and able to give an informed consent.

Locations
Other Locations
Finland
Jorvi hospital / HUS
RECRUITING
Espoo
Contact Information
Primary
Roman Kornõšev, MD
roman.kornosev@hus.fi
+358 504 279755
Backup
Alexey Schramko, MD, PhD, Doc
alexey.schramko@hus.fi
+358 504 270610
Time Frame
Start Date: 2024-01-16
Estimated Completion Date: 2027-10
Participants
Target number of participants: 850
Treatments
Experimental: Daycare: STALL
Local ropivacaine infiltration + laparoscopically controlled TAP (transversus abdominis plane block). Daycare patients.
Active_comparator: Daycare: local only
Local ropivacaine infiltration only. Daycare patients.
Experimental: In-patient: STALL
Local ropivacaine infiltration + laparoscopically controlled TAP. In-patient surgery.
Active_comparator: In-patient: local only
Local ropivacaine infiltration only. In-patient surgery.
Experimental: Emergency: STALL
Local ropivacaine infiltration + laparoscopically controlled TAP. Emergency patients.
Active_comparator: Emergency: local only
Local ropivacaine infiltration only. Emergency patients.
Sponsors
Leads: Helsinki University Central Hospital

This content was sourced from clinicaltrials.gov

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