NCT04108221

Study Comparing Two Methods of TransversusAbdominis Plane

Randomised Study of Noninferiority Comparing a TransversusAbdominis Plane Block Surgical (c-TAP Block) to the Ultrasound-guided Abdominis Plane Block Transversus (Us-TAP Block) in Postoperative Analgesia After Laparoscopy or Laparotomy

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Institut Jean-Godinot · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Interventional, randomised, prospective, multicentric study

Detailed description

Interventional, randomised, prospective, multicentric and single blind study Primary objective : demonstrate the equivalence of c-TAP Block to us-TAP Block in postoperative analgesia Secondary objective : * Assess the effectiveness of c-TAP block on us-TAP Block in the obese and/or malnourished patient subgroup * Compare the running time of the c-TAP Block to the us-TAP Block * Assess the safety of the c-TAP Block gesture in terms of trauma to the intraperitoneal organs by the injection needle two groups: * Arm A : c-TAP Block performed by the surgeon * Arm B : us-TAP Block performed by the anesthesist under ultrasound control Schedule : * Inclusions start at: 16/09/2019 * End date of inclusions: 31/03/2022 * End date of follow-up: 01/04/2022 * Study report: 30/09/2022

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
PROCEDURE	laparoscopy or laparotomy withTransversusAbdominis Plane Block	The US-TAP is performed by the anesthetist under ultrasound control after the end of the procedure of laparoscopy or laparotomy. Under sterile conditions, the anesthetist identifies the oblique abdominal muscles externally, obliquely internally and transversely by ultrasound. A 20 ml needle of 0.5% ropivacaine is injected. The surgical TAP (c-TAP) block is performed by the surgeon at the end of the procedure of laparoscopy or laparotomy.The needle and the product used are identical to those of the us-TAP block. The positioning of the needle is in the plane of the fascia between the internal oblique muscle and the transverse muscle, identified by a significant loss of resistance.

Timeline

• Start date: 2019-09-16
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2019-09-30
• Last updated: 2022-04-07

Locations

1 site across 1 country: France