Study Comparing Two Methods of TransversusAbdominis Plane
NCT ID: NCT04108221
Last Updated: 2022-04-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
140 participants
INTERVENTIONAL
2019-09-16
2022-03-31
Brief Summary
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Detailed Description
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Primary objective :
demonstrate the equivalence of c-TAP Block to us-TAP Block in postoperative analgesia
Secondary objective :
* Assess the effectiveness of c-TAP block on us-TAP Block in the obese and/or malnourished patient subgroup
* Compare the running time of the c-TAP Block to the us-TAP Block
* Assess the safety of the c-TAP Block gesture in terms of trauma to the intraperitoneal organs by the injection needle two groups:
* Arm A : c-TAP Block performed by the surgeon
* Arm B : us-TAP Block performed by the anesthesist under ultrasound control
Schedule :
* Inclusions start at: 16/09/2019
* End date of inclusions: 31/03/2022
* End date of follow-up: 01/04/2022
* Study report: 30/09/2022
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Arm A : c-TAP Block performed by surgeon
c-TAP Block Block performed by surgeon
laparoscopy or laparotomy withTransversusAbdominis Plane Block
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.
Arm B : us-TAP Block performed by anesthetist
us-TAP Block by anesthetist
laparoscopy or laparotomy withTransversusAbdominis Plane Block
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.
Interventions
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laparoscopy or laparotomy withTransversusAbdominis Plane Block
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.
Eligibility Criteria
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Inclusion Criteria
* Patient undergoing laparoscopic or laparotomic abdominal surgery at the investigator hospital.
* Patient mastering the French language
* Patient who received informed information about the study and signed a consent
* Patient affiliated to a social security scheme.
Exclusion Criteria
* Patients with opioid dependence
* Patients allergic to local anesthetic
* Patient who has not signed the consent of the study.
18 Years
ALL
No
Sponsors
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Institut Jean-Godinot
OTHER
Responsible Party
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Principal Investigators
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Jean Christophe EYMARD, PI
Role: PRINCIPAL_INVESTIGATOR
Institut GODINOT
Locations
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Institut Godinot
Reims, , France
Countries
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Other Identifiers
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2019-A01444-53
Identifier Type: -
Identifier Source: org_study_id
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