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

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

Study Overview

• Status: Completed
• Conditions: Surgery; Stoma Ileostomy
• Intervention / Treatment: Procedure: Trans abdominal plane

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

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: 33 4 73 754 963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • CHU
  • Rennes, France, 35033
    • CHU Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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
Experimental: TAP block; In addition of usual practice, patients receiving a TAP block at the beginning of the surgery	Procedure: Trans abdominal plane; Trans abdominal plane block is performed with ultra sound guidance.; - 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).; - 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quo 40 score	Once the patient is transferred in post operative surgical service, assessment of the primary outcome will be done by the physician in charge of the patient. Quo 40 score is a postoperative recovery score above 200 points validated by Myles et al in 2001.	Day 1 (

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS (Numeric rating scale)	Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service	Day 1 : At the entrance of recovery room
NRS (Numeric rating scale)	Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service	Day 1
NRS (Numeric rating scale)	Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service	Day 2
Quo 40 score	Once the patient is transferred in post operative surgical service, assessment of the primary outcome will be done by the physician in charge of the patient. Quo 40 score is a postoperative recovery score above 200 points validated by Myles et al in 2001.	Day 15
Time spent in recovery room	Assessment of time spent in recovery room (ie: entrance in recovery room until Aldrede score is >9) performed by nurses (Until 6 hours).	At the output of recovery room ie until 6 hours after intervention

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Marie Vignaud, CHU Clermont-Ferrand.fr

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2019
• Primary Completion (Actual): April 17, 2023
• Study Completion (Actual): April 17, 2023

Study Registration Dates

• First Submitted: May 20, 2019
• First Submitted That Met QC Criteria: May 31, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Post operative pain; Prospective randomized pilot study; Trans abdominal plane block; Quo R 40 score
• Other Study ID Numbers: RBHP 2019 VIGNAUD - Tapas; 2019-001022-95 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No