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
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
149
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.
CHU
Clermont-Ferrand, France
CHU Rennes
Rennes, France
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: At the output of recovery room ie until 6 hours after intervention
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