Study Comparing Two Methods of TransversusAbdominis Plane

Study Overview
=================
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

Official Title
-----------------
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

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Procedure: laparoscopy or laparotomy withTransversusAbdominis Plane Block


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two arms : arm A : c-TAP Block performed by surgeon arm B : us-TAP Block performed by anesthetist
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A : c-TAP Block performed by surgeon<br>c-TAP Block Block performed by surgeon | Procedure: laparoscopy or laparotomy withTransversusAbdominis Plane Block<br>* 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.<br>|
| Active Comparator: Arm B : us-TAP Block performed by anesthetist<br>us-TAP Block by anesthetist | Procedure: laparoscopy or laparotomy withTransversusAbdominis Plane Block<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Evolution pain intensity scores, assessed by the numerical pain scale (EN 1 up to 10) | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure rate in the obese and / or malnourished patient subgroup | The failure will be defined as follows: a pain evaluated at> 4/10 on EN that requires intravenous or systemic analgesia | 24 hours | 
| Time in minutes of each of the TAP Block techniques | 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 | 24 hours | 
| Occurrence of trauma to the intra-abdominal organs caused by the injection needle | number of traumas that have occurred | 24 hours |