Study Comparing Two Methods of TransversusAbdominis Plane (CHIRTAP)

Institut Jean-Godinot

Status: Suspended

Conditions: Pain, Postoperative

Treatments: Procedure: laparoscopy or laparotomy withTransversusAbdominis Plane Block

Study type: Interventional

Funder types: Other

Identifiers

NCT04108221

2019-A01444-53

Details and patient eligibility

About

Interventional, randomised, prospective, multicentric study

Full 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

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

Arm A : c-TAP Block performed by surgeon

Experimental group

Description:

c-TAP Block Block performed by surgeon

Treatment:

Procedure: laparoscopy or laparotomy withTransversusAbdominis Plane Block

Arm B : us-TAP Block performed by anesthetist

Active Comparator group

Description:

us-TAP Block by anesthetist

Treatment:

Procedure: laparoscopy or laparotomy withTransversusAbdominis Plane Block