- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05546970
Efficacy of the Transversus Abdominis Plane Block on Analgesia After Cephalic Duodeno-pancreatectomy (TAP-Block)
December 13, 2023 updated by: University Hospital, Strasbourg, France
Efficacy of the Transversus Abdominis Plane Block (TAP-Block) on Analgesia After Cephalic Duodeno-pancreatectomy
Pancreatic duodenectomy is one of the treatments offered to patients with neoplastic disease of the pancreas.
In France, in 2018, 14,000 duodeno-pancreatectomies were performed, including 140 at the Hautepierre hospital at the Strasbourg University Hospital.
Pancreaticoduodenectomy is a major surgery, causing significant postoperative pain that should be minimized through multimodal analgesia involving in particular locoregional anesthesia.
Since 2019, the recommendations of the ERAS company concerning ERAS (Improved Rehabilitation After Surgery) after pancreaticoduodenectomy recommend the establishment of thoracic epidural analgesia in order to limit postoperative pain.
When there is a contraindication to the placement of a thoracic epidural, in particular due to arterial and/or venous vascular reconstructions requiring potential perioperative curative anticoagulation, the administration of local anesthetic by pericatricial catheter is recommended.
recommended.
The Transversus Abdominis Plane (TAP) block has proven analgesic efficacy, safety and harmlessness in colorectal surgery.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Strasbourg, France, 67091
- Service d'Anesthésie, Réanimation et Médecine péri-Opératoire - CHU de Strasbourg - France
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Major subject (≥18 years of age) operated at HUS for cephalic duodeno-pancreatectomy between 01/01/2018 and 01/04/ 2022
Description
Inclusion criteria:
- Major subject (≥18 years of age)
- Subject operated at HUS for cephalic duodeno-pancreatectomy between 01/01/2018 and 01/04/ 2022.
- Subject who has not expressed an objection to the reuse of their data for scientific research purposes.
Exclusion Criteria:
- Subject having expressed his/her opposition to participate in the study
- Admission in intensive care unit after the operation
- Morphine treatment at home
- Drug addiction, weaned or not
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Efficacy of the echo-guided TAP Block on analgesia
Time Frame: Morphine consumption in the first 24 postoperative hours
|
Morphine consumption in the first 24 postoperative hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2022
Primary Completion (Actual)
February 28, 2023
Study Completion (Actual)
May 29, 2023
Study Registration Dates
First Submitted
September 15, 2022
First Submitted That Met QC Criteria
September 15, 2022
First Posted (Actual)
September 21, 2022
Study Record Updates
Last Update Posted (Actual)
December 19, 2023
Last Update Submitted That Met QC Criteria
December 13, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8703 (Other Identifier: CTEP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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