Study Comparing Two Methods of TransversusAbdominis Plane (CHIRTAP)

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

Interventional, randomised, prospective, multicentric study

Study Overview

• Status: Suspended
• Conditions: Pain, Postoperative
• Intervention / Treatment: Procedure: laparoscopy or laparotomy withTransversusAbdominis Plane Block

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 Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Reims, France, 51726
    • Institut Godinot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A : c-TAP Block performed by surgeon; c-TAP Block Block performed by surgeon	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.
Active Comparator: Arm B : us-TAP Block performed by anesthetist; us-TAP Block by anesthetist	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.

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

Collaborators and Investigators

• Sponsor: Institut Jean-Godinot
• Investigators: Principal Investigator: Jean Christophe EYMARD, PI, Institut Godinot

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2019
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 7, 2022
• Last Update Submitted That Met QC Criteria: March 29, 2022
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2019-A01444-53

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No