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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05546970
Other study ID # 8703
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2022
Est. completion date May 29, 2023

Study information

Verified date December 2023
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date May 29, 2023
Est. primary completion date February 28, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Service d'Anesthésie, Réanimation et Médecine péri-Opératoire - CHU de Strasbourg - France Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy of the echo-guided TAP Block on analgesia Morphine consumption in the first 24 postoperative hours
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