CHIRTAP: Study Comparing Two Methods of TransversusAbdominis Plane

Sponsor

Institut Jean-Godinot (Other)

Overall Status

Suspended

CT.gov ID

NCT04108221

Collaborator

(none)

140

Enrollment

Location

Arms

30.5

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Interventional, randomised, prospective, multicentric study

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Procedure: laparoscopy or laparotomy withTransversusAbdominis Plane Block	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

two arms : arm A : c-TAP Block performed by surgeon arm B : us-TAP Block performed by anesthetisttwo arms : arm A : c-TAP Block performed by surgeon arm B : us-TAP Block performed by anesthetist

Masking:

Single (Investigator)

Primary Purpose:

Other

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

Actual Study Start Date :

Sep 16, 2019

Anticipated Primary Completion Date :

Mar 31, 2022

Anticipated Study Completion Date :

Mar 31, 2022

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut Godinot	Reims		France	51726

Sponsors and Collaborators

Institut Jean-Godinot

Investigators

Principal Investigator: Jean Christophe EYMARD, PI, Institut GODINOT

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut Jean-Godinot

ClinicalTrials.gov Identifier:

NCT04108221

Other Study ID Numbers:

2019-A01444-53

First Posted:

Sep 30, 2019

Last Update Posted:

Apr 7, 2022

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Apr 7, 2022