Study Comparing Two Methods of TransversusAbdominis Plane

Not Applicable

Suspended

• Conditions: Pain, Postoperative
• Interventions: Procedure: laparoscopy or laparotomy withTransversusAbdominis Plane Block

• Registration Number: NCT04108221
• Lead Sponsor: Institut Jean-Godinot

Brief 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

Study Timeline

• Study Start: 2019-09-16
• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-30
• Status Verified: 2021-06
• Last Update Submitted: 2022-03-29
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Patient over 18 years old

• Patient undergoing laparoscopic or laparotomic abdominal surgery at the investigator hospital.
• Patient mastering the French language
• Patient who received informed information about the study and signed a consent
• Patient affiliated to a social security scheme.

Exclusion Criteria

• Patients with chronic pain
• Patients with opioid dependence
• Patients allergic to local anesthetic
• Patient who has not signed the consent of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B : us-TAP Block performed by anesthetist	laparoscopy or laparotomy withTransversusAbdominis Plane Block	us-TAP Block by anesthetist
Arm A : c-TAP Block performed by surgeon	laparoscopy or laparotomy withTransversusAbdominis Plane Block	c-TAP Block Block performed by surgeon

Primary Outcome Measures

Name	Time	Method
Evolution pain intensity scores, assessed by the numerical pain scale (EN), postoperative and need for systemic analgesics (intravenously or by mouth) during the 24 hours following the end of the procedure	24 hours	Evolution pain intensity scores, assessed by the numerical pain scale (EN 1 up to 10)

Secondary Outcome Measures

Name	Time	Method
Failure rate in the obese and / or malnourished patient subgroup	24 hours	The failure will be defined as follows: a pain evaluated at\> 4/10 on EN that requires intravenous or systemic analgesia
Time in minutes of each of the TAP Block techniques	24 hours	The time will be quantified with a stopwatch. For the c-TAP, the stopwatch will be started as soon as the injection equipment of the locoregional anesthesia is received. For the us-TAP block, the stopwatch will be started after the end of the surgical procedure and as soon as the anesthetist starts to wash his hands to proceed with the injection
Occurrence of trauma to the intra-abdominal organs caused by the injection needle	24 hours	number of traumas that have occurred

Trial Locations

Locations (1)

Institut Godinot; 🇫🇷 Reims, France