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Brief Title: 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 ID: NCT06123117
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Jorvi hospital / HUS, Espoo, Karvasmäentie 8, Finland
Name: Henna Sammalkorpi, MD, PhD
Affiliation: Helsinki UCH
Role: STUDY_DIRECTOR
Name: Hanna Lampela, MD, PhD
Affiliation: Helsinki UCH
Role: STUDY_DIRECTOR
Name: Jukka Harju, MD, PhD, Doc
Affiliation: Helsinki UCH
Role: STUDY_DIRECTOR