Study Comparing Two Methods of TransversusAbdominis Plane

Institut Jean-Godinot140 enrolled

Overview

Interventional, randomised, prospective, multicentric study

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

140

Conditions

Pain, Postoperative

Interventions

laparoscopy or laparotomy withTransversusAbdominis Plane BlockPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Institut Godinot

Reims, France

Outcomes

Primary Outcomes

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)

Time frame: 24 hours

Secondary Outcomes

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

Time frame: 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

Time frame: 24 hours

Occurrence of trauma to the intra-abdominal organs caused by the injection needle

number of traumas that have occurred

Time frame: 24 hours

Data from ClinicalTrials.gov

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