Study Comparing Two Methods of TransversusAbdominis Plane

NCT04108221 | Suspended DMC

• 1 other identifier: 2019-A01444-53
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Interventional, randomised, prospective, multicentric study

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Failure rate in the obese and / or malnourished patient subgroup

  24 hours

• Time in minutes of each of the TAP Block techniques

  24 hours

• Occurrence of trauma to the intra-abdominal organs caused by the injection needle

  24 hours

Study Arms (2)

Arm A : c-TAP Block performed by surgeon

EXPERIMENTAL

c-TAP Block Block performed by surgeon

Procedure: laparoscopy or laparotomy withTransversusAbdominis Plane Block

Arm B : us-TAP Block performed by anesthetist

ACTIVE COMPARATOR

us-TAP Block by anesthetist

Procedure: laparoscopy or laparotomy withTransversusAbdominis Plane Block

Interventions

laparoscopy or laparotomy withTransversusAbdominis Plane Block PROCEDURE

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 A : c-TAP Block performed by surgeon; Arm B : us-TAP Block performed by anesthetist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with chronic pain
• Patients with opioid dependence
• Patients allergic to local anesthetic
• Patient who has not signed the consent of the study.

Sponsors & Collaborators

• Institut Jean-Godinot: lead

Study Sites (1)

Institut Godinot

Reims, 51726, France

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jean Christophe EYMARD, PI

  Institut GODINOT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 30, 2019
• Study Start: September 16, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 7, 2022

Record last verified: 2021-06

Locations

FR (1)