Study Comparing Two Methods of TransversusAbdominis Plane (CHIRTAP)
Primary Purpose
Pain, Postoperative
Status
Suspended
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
laparoscopy or laparotomy withTransversusAbdominis Plane Block
Sponsored by
About this trial
This is an interventional other trial for Pain, Postoperative
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.
Sites / Locations
- Institut Godinot
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A : c-TAP Block performed by surgeon
Arm B : us-TAP Block performed by anesthetist
Arm Description
c-TAP Block Block performed by surgeon
us-TAP Block by anesthetist
Outcomes
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
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
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
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
number of traumas that have occurred
Full Information
NCT ID
NCT04108221
First Posted
September 26, 2019
Last Updated
March 29, 2022
Sponsor
Institut Jean-Godinot
1. Study Identification
Unique Protocol Identification Number
NCT04108221
Brief Title
Study Comparing Two Methods of TransversusAbdominis Plane
Acronym
CHIRTAP
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Suspended
Why Stopped
Principal Investigator condition
Study Start Date
September 16, 2019 (Actual)
Primary Completion Date
March 31, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Jean-Godinot
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two arms : arm A : c-TAP Block performed by surgeon arm B : us-TAP Block performed by anesthetist
Masking
Investigator
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A : c-TAP Block performed by surgeon
Arm Type
Experimental
Arm Description
c-TAP Block Block performed by surgeon
Arm Title
Arm B : us-TAP Block performed by anesthetist
Arm Type
Active Comparator
Arm Description
us-TAP Block by anesthetist
Intervention Type
Procedure
Intervention Name(s)
laparoscopy or laparotomy withTransversusAbdominis Plane Block
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
Evolution pain intensity scores, assessed by the numerical pain scale (EN 1 up to 10)
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Failure rate in the obese and / or malnourished patient subgroup
Description
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
Title
Time in minutes of each of the TAP Block techniques
Description
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
Title
Occurrence of trauma to the intra-abdominal organs caused by the injection needle
Description
number of traumas that have occurred
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Christophe EYMARD, PI
Organizational Affiliation
Institut GODINOT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut Godinot
City
Reims
ZIP/Postal Code
51726
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study Comparing Two Methods of TransversusAbdominis Plane
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