Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal and Its Effect on Post Operative Recovery: a Prospective, Randomized, Muticenter Study

NCT ID: NCT03971513

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-17
• Study Completion Date: 2023-04-17

Brief Summary

The primary purpose of TAPAS study is to demonstrate the superiority of analgesic effect of trans abdominal plane block (TAP block) performed at the beginning of stoma reversal, compared to standard of care.

The hypothesize is that a TAP block performed at the beginning of surgery of stoma reversal would improve patient's satisfaction (evaluated by Quo-r40 questionnaire), would reduce the incidence of post operative pain, time spent in recovery room, and reduce hospitalisation time

Detailed Description

The patient will arrive in the department the day before the surgical intervention (D-1). During this preoperative visit (D-1), the investigator

• will preselect potentially eligible patients
• will offer to participate to this study
• will give the notice form to the patients
• will present the research: objectives, benefits and constraints for the patients

The intervention day (D0):

The investigator will collect the signed consent form after having ascertained the understanding of the notice form by the patient and checking the inclusion and non-inclusion criteria.

The randomization will be done via the eCRF module (allocation group and number) and the preoperative data registration in the eCRF.

Surgical Intervention (D1):

All patients will receive standard anaesthesia using sufentanyl, propopol, cisatracurium and sevoflurane. Prevention of nausea and vomiting is performing using Apfel score. Anti microbial prophylaxis is performed according recommendations.

All patients will receive post operative multimodal analgesia using, acetaminophene, ketaminophene (if no contra indication), nefopam, and morphine if NRS (numerating rating scale) > 3 At the end of the surgery, patients in the experimental group will receive a ultrasound guided trans abdominal plane block with 20 ml of 5 mg/mg of ropivacaine. Patients in the control group will not receive the block

Conditions

Surgery; Stoma Ileostomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

usual practice

Control group (usual practice): patients receiving a general anaesthesia with propofol, sufentanyl and cisatracurium for the induction, and sevoflurane, sufentanyl and cisatracurium for the maintenance. Patients receiving a multimodal intravenous analgesia, with acetaminophen, ketoprophen, nefopam and morphine. if necessary. Antimicrobial prophylaxis is performed according to recommendations

Group Type: NO_INTERVENTION

No interventions assigned to this group

TAP block

In addition of usual practice, patients receiving a TAP block at the beginning of the surgery

Group Type: EXPERIMENTAL

Trans abdominal plane

Intervention Type: PROCEDURE

Trans abdominal plane block is performed with ultra sound guidance.

1. - The high frequency probe is placed right to the umbilicus, and slips laterally to the side to block. It allows showing the three belts of larges muscles of abdomen (External Oblicum, internal oblicum, and transversal of the abdomen).

2. - When the needle is visualised in the plan separating the muscle internal oblicum and transversal of the abdomen, 20 ml of ropivacaïne 5mg/ml are injected after aspiration test. If in doubt, hydro localisation car be realised.

Interventions

Trans abdominal plane

Trans abdominal plane block is performed with ultra sound guidance.

1. - The high frequency probe is placed right to the umbilicus, and slips laterally to the side to block. It allows showing the three belts of larges muscles of abdomen (External Oblicum, internal oblicum, and transversal of the abdomen).

2. - When the needle is visualised in the plan separating the muscle internal oblicum and transversal of the abdomen, 20 ml of ropivacaïne 5mg/ml are injected after aspiration test. If in doubt, hydro localisation car be realised.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age > 18 years old
• Patients operated of a scheduled stoma reversal surgery
• Patients having given consent in the mannen described in Article L1122-1-1 of the Public Health Code
• Patients affiliated with asocial security regimen or beneficiary of such a regimen

Exclusion Criteria

• Renal insufficiency (ie glomerular filtration output < 35 ml/min)
• Patients with chronic inflammatory bowel disease
• Body mass index > 35 kg/m2
• Chronic pain with opiates
• Patients with cognitive troubles
• Coagulation disorders (platelets count < 80G/L, PT< 50%, V factor < 50%)
• Pregnancy
• Breastfeeding
• Local anesthesics (amide class) allergy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie Vignaud

Role: PRINCIPAL_INVESTIGATOR

CHU Clermont-Ferrand.fr

Locations

CHU

Clermont-Ferrand, , France

CHU Rennes

Rennes, , France

Countries

France

Other Identifiers

2019-001022-95

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2019 VIGNAUD - Tapas

Identifier Type: -

Identifier Source: org_study_id