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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001022-95 | Other Identifier | ANSM |
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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
The patient will arrive in the department the day before the surgical intervention (D-1). During this preoperative visit (D-1), the investigator
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual practice | No Intervention | 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 | |
| TAP block | Experimental | In addition of usual practice, patients receiving a TAP block at the beginning of the surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trans abdominal plane | Procedure | Trans abdominal plane block is performed with ultra sound guidance.
|
| 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 ( |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie Vignaud | CHU Clermont-Ferrand.fr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU | Clermont-Ferrand | France | ||||
| CHU Rennes |
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Model description:
Randomization in 2 groups
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|
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 |
| Rennes |
| 35033 |
| France |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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