Clinical trial NCT03971513: Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal and Its Effect on Post Operative Recovery: a Prospective, Randomized, Muticenter Study
Official title: Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal and Its Effect on Post Operative Recovery: a Prospective, Randomized, Muticenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Stoma Ileostomy
Keywords: Prospective randomized pilot study
Trans abdominal plane block
Quo R 40 score
Post operative pain
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Quo 40 score
timeFrame: Day 1 (
Secondary outcomes:
measure: NRS (Numeric rating scale)
timeFrame: Day 1 : At the entrance of recovery room
measure: NRS (Numeric rating scale)
timeFrame: Day 1
measure: NRS (Numeric rating scale)
timeFrame: Day 2
measure: Quo 40 score
timeFrame: Day 15
measure: Time spent in recovery room
timeFrame: At the output of recovery room ie until 6 hours after intervention
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU
city: Rennes
country: France
facility: CHU Rennes
Study officials:
affiliation: CHU Clermont-Ferrand.fr
name: Marie Vignaud
role: PRINCIPAL_INVESTIGATOR
References: