SuspendedNCT04108221CHIRTAPUpdated Apr 7, 2022

Study Comparing Two Methods of TransversusAbdominis Plane

An interventional study of laparoscopy or laparotomy withTransversusAbdominis Plane Block in Pain, Postoperative, sponsored by Institut Jean-Godinot. Suspended at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-07.

Sponsored by Institut Jean-Godinot · Not applicable, Interventional, and Other

Why this study was suspended

Principal Investigator condition

Phase: Not applicable
Study type: Interventional
Enrollment: 140
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

Interventional, randomised, prospective, multicentric study

Read the 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

Conditions studied

Pain, Postoperative

Browse trials for

Pain, Postoperative 5,043

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Not applicable
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Investigator)
Enrollment: 140 participants (estimated)

Study arms

Experimental
Arm A : c-TAP Block performed by surgeon
c-TAP Block Block performed by surgeon
Procedure: laparoscopy or laparotomy withTransversusAbdominis Plane Block
Active comparator
Arm B : us-TAP Block performed by anesthetist
us-TAP Block by anesthetist
Procedure: laparoscopy or laparotomy withTransversusAbdominis Plane Block

Interventions

Procedurelaparoscopy 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 researchers measure

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

Study locations

1 site

Institut Godinot
Reims, 51726, France

Registry details

Key details

Study ID: NCT04108221
Lead sponsor: Institut Jean-Godinot
Responsible party: Sponsor
First posted: Sep 30, 2019
Start date: Sep 16, 2019
Primary completion: Mar 31, 2022 (estimated)
Completion: Mar 31, 2022 (estimated)
Last update: Apr 7, 2022

Study contacts

Jean Christophe EYMARD, PI

principal investigator · Institut GODINOT

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is suspended, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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