NCT04427059

A Study to Compare Two Techniques for Pain Control After Bariatric Surgery

Laparoscopic Assisted Transversus Abdominis Plane (TAP) Block Vs Local Anesthetic Infiltrations in Bariatric Surgery: a Prospective Randomized Double-Blind Controlled Trial (TAP BLOCK BARIATRIC TRIAL)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Fabio Garofalo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the postoperative pain and other clinical outcomes in patients who, during bariatric surgery, will be injected with a local anesthetic (Ropivacaine) through two different techniques.

Conditions

• Pain, Postoperative
• Bariatric Surgery Candidate

Interventions

Type	Name	Description
PROCEDURE	Transversus Abdominis Plane (TAP) block	The laparoscopic-assisted Transversus Abdominis Plane (TAP) block will be done just after the optic trocar placement as follow: as landmarks we use the anterior axillary line, in the middle between the iliac crest and the costal margin. After insertion of the optic trocar the peritoneum is visualized. A 14 Gauge needle is inserted 2 cm cranially respect the taken landmark through the skin until the penetration of the internal and external oblique fascias, identified as sudden lowering of resistance. Laparoscopy allows to confirm that the needle did not pass the peritoneum. A solution of 20 ml of Ropivacaine (0.25%) is then injected, observing the formation of a bulge posterior to the transversus abdominis muscle. The procedure is then repeated identically on the contralateral side.
PROCEDURE	Port-Site Infiltration (PSI)	The Port-Site Infiltration (PSI) will be performed by infiltrating the subcutis and the skin at the trocar site before the trocar placements with a solution of local anesthetic (Ropivacaine 0.25%), a total of 40 ml will be administered.

Timeline

• Start date: 2020-06-15
• Primary completion: 2021-07-07
• Completion: 2021-07-07
• First posted: 2020-06-11
• Last updated: 2021-10-06

Locations

1 site across 1 country: Switzerland