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Principal Investigator condition
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Interventional, randomised, prospective, multicentric study
Interventional, randomised, prospective, multicentric and single blind study
Primary objective :
demonstrate the equivalence of c-TAP Block to us-TAP Block in postoperative analgesia
Secondary objective :
Schedule :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A : c-TAP Block performed by surgeon | Experimental | c-TAP Block Block performed by surgeon |
|
| Arm B : us-TAP Block performed by anesthetist | Active Comparator | us-TAP Block by anesthetist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopy or laparotomy withTransversusAbdominis Plane Block | Procedure | The US-TAP is performed by the anesthetist under ultrasound control after the end of the procedure of laparoscopy or laparotomy. Under sterile conditions, the anesthetist identifies the oblique abdominal muscles externally, obliquely internally and transversely by ultrasound. A 20 ml needle of 0.5% ropivacaine is injected. The surgical TAP (c-TAP) block is performed by the surgeon at the end of the procedure of laparoscopy or laparotomy.The needle and the product used are identical to those of the us-TAP block. The positioning of the needle is in the plane of the fascia between the internal oblique muscle and the transverse muscle, identified by a significant loss of resistance. |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution pain intensity scores, assessed by the numerical pain scale (EN), postoperative and need for systemic analgesics (intravenously or by mouth) during the 24 hours following the end of the procedure | Evolution pain intensity scores, assessed by the numerical pain scale (EN 1 up to 10) | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Failure rate in the obese and / or malnourished patient subgroup | The failure will be defined as follows: a pain evaluated at> 4/10 on EN that requires intravenous or systemic analgesia | 24 hours |
| Time in minutes of each of the TAP Block techniques |
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Inclusion Criteria:
Patient over 18 years old
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Christophe EYMARD, PI | Institut GODINOT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Godinot | Reims | 51726 | France |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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two arms : arm A : c-TAP Block performed by surgeon arm B : us-TAP Block performed by anesthetist
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The time will be quantified with a stopwatch. For the c-TAP, the stopwatch will be started as soon as the injection equipment of the locoregional anesthesia is received. For the us-TAP block, the stopwatch will be started after the end of the surgical procedure and as soon as the anesthetist starts to wash his hands to proceed with the injection
| 24 hours |
| Occurrence of trauma to the intra-abdominal organs caused by the injection needle | number of traumas that have occurred | 24 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |