NCT05546970

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2023

Completed
Last Updated

December 19, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

September 15, 2022

Last Update Submit

December 13, 2023

Conditions

Keywords

Neoplastic DiseasePancreatic neoplasiaPancreatic NeoplasmsTransversus Abdominis Plane BlockTAP-BlockCephalic duodeno-pancreatectomy

Outcome Measures

Primary Outcomes (1)

  • Efficacy of the echo-guided TAP Block on analgesia

    Morphine consumption in the first 24 postoperative hours

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Anesthésie, Réanimation et Médecine péri-Opératoire - CHU de Strasbourg - France

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Pancreatic NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 21, 2022

Study Start

September 1, 2022

Primary Completion

February 28, 2023

Study Completion

May 29, 2023

Last Updated

December 19, 2023

Record last verified: 2023-12

Locations