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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Surgery, Stoma Ileostomy

Intervention / Treatment
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* Procedure: Trans abdominal plane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Model description: Randomization in 2 groups 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 group: 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, nefopan and morphine if necessary Antimicrobial prophylaxis is performed according to recommendations. In this group, a trans abdominal plane block, using 20 ml of ropivacaine 5 mg/ml is performed at the beginning of surgery, using ultrasound guidance.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: usual practice<br>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<br>In addition of usual practice, patients receiving a TAP block at the beginning of the surgery | Procedure: Trans abdominal plane<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trans abdominal plane block, Quo R 40 score, Post operative pain, Prospective randomized pilot study