Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal and Its Effect on Post Operative Recovery: a Prospective, Randomized, Muticenter Study
- Conditions
- SurgeryStoma Ileostomy
- Interventions
- Procedure: Trans abdominal plane
- Registration Number
- NCT03971513
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 149
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAP block Trans abdominal plane In addition of usual practice, patients receiving a TAP block at the beginning of the surgery
- Primary Outcome Measures
Name Time Method Quo 40 score Day 1 ( 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.
- Secondary Outcome Measures
Name Time Method Time spent in recovery room At the output of recovery room ie until 6 hours after intervention Assessment of time spent in recovery room (ie: entrance in recovery room until Aldrede score is \>9) performed by nurses (Until 6 hours).
Quo 40 score Day 15 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.
NRS (Numeric rating scale) Day 2 Numerating rating score variating from 0 to 10, done by nurses in operating room and in post operative surgical service
Trial Locations
- Locations (2)
CHU Rennes
🇫🇷Rennes, France
CHU
🇫🇷Clermont-Ferrand, France