STALL vs Sole Local Wound Infiltration in Laparoscopic Cholecystectomy

Helsinki University Central Hospital (HUCH)

Status: Enrolling

Conditions: Gallbladder Cancer; Cholecystitis; Cholelithiasis

Treatments: Procedure: single transversus abdominis laparoscopy-guided plane block; Procedure: local trocar site ropivacaine infiltration

Study type: Interventional

Funder types: Other

Identifiers

NCT06123117

7351

Details and patient eligibility

About

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.

Enrollment: 850 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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850 participants in 6 patient groups

Daycare: STALL

Experimental group

Description:

Local ropivacaine infiltration + laparoscopically controlled TAP (transversus abdominis plane block). Daycare patients.

Treatment:

Procedure: local trocar site ropivacaine infiltration

Procedure: single transversus abdominis laparoscopy-guided plane block

Daycare: local only

Active Comparator group

Description:

Local ropivacaine infiltration only. Daycare patients.

Treatment:

Procedure: local trocar site ropivacaine infiltration

In-patient: STALL

Experimental group

Description:

Local ropivacaine infiltration + laparoscopically controlled TAP. In-patient surgery.

Treatment:

Procedure: local trocar site ropivacaine infiltration

Procedure: single transversus abdominis laparoscopy-guided plane block

In-patient: local only

Active Comparator group

Description:

Local ropivacaine infiltration only. In-patient surgery.

Treatment:

Procedure: local trocar site ropivacaine infiltration

Emergency: STALL

Experimental group

Description:

Local ropivacaine infiltration + laparoscopically controlled TAP. Emergency patients.

Treatment:

Procedure: local trocar site ropivacaine infiltration

Procedure: single transversus abdominis laparoscopy-guided plane block

Emergency: local only

Active Comparator group

Description:

Local ropivacaine infiltration only. Emergency patients.

Treatment:

Procedure: local trocar site ropivacaine infiltration