Study Comparing Two Methods of TransversusAbdominis Plane

Pain, Postoperative Clinical Trial

— 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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04108221
• Other study ID #: 2019-A01444-53
• Status: Suspended
• Phase: N/A
• Start date: September 16, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: June 2021
• Source: Institut Jean-Godinot
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Interventional, randomised, prospective, multicentric study

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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 140
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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.

Locations

Country	Name	City	State
France	Institut Godinot	Reims

Sponsors (1)

Lead Sponsor	Collaborator
Institut Jean-Godinot

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Occurrence of trauma to the intra-abdominal organs caused by the injection needle	number of traumas that have occurred	24 hours