Trans Abdominal Plane Block (TAP Block) in Surgery of Stoma Reversal & Its

Status Completed

Clinical Trial 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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03971513
Study type	Interventional
Source	University Hospital, Clermont-Ferrand
Contact
Status	Completed
Phase	N/A
Start date	June 17, 2019
Completion date	April 17, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms