Effectiveness of the Transversus Abdominis Plane Block Associated With Opioid Spinal Anesthesia on Analgesia After Cephalic Duodenopancreatectomy

NCT ID: NCT06499792

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 160 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-03
• Study Completion Date: 2024-12-31

Brief Summary

Duodenopancreatectomy is a major, risky surgery that causes significant post-operative pain. Optimizing perioperative analgesia remains a challenge, and requires multimodal management, notably involving locoregional analgesic techniques.

The thoracic epidural helps reduce perioperative pain, as well as certain postoperative complications. However, epidural analgesia is not without effects, and the data remains quite heterogeneous depending on the studies regarding its benefits and risks: more frequent hypotension, significant technical failures, length of hospitalization depending on the series, marginal benefit clinically of little relevance... And the existence of contraindications to the epidural such as the performance of vascular resections requiring curative intraoperative anticoagulation also limit its daily use.

The search for alternatives to the epidural in this context has seen the emergence of the use of intrathecal injection of Morphine and the performance of TAP Block perioperatively for duodenopancreatectomies. Morphine spinal anesthesia is an analgesic technique that is simpler and just as effective as the thoracic epidural. The TAP Block has also proven its effectiveness in major colorectal surgeries.

The literature on the subject remains poor and very few studies have focused on alternatives to thoracic epidurals. If the superiority of TAP Block and spinal anesthesia have been evaluated in isolation, no study has yet compared the effectiveness of the combination of TAP Block-Spinal anesthesia compared to that of TAP Block alone in the management of post pain. duodenopancreatectomy.

At the Strasbourg University Hospital, the Anesthesia team in hepatic and pancreatic surgery made a change in practice in June 2023: from a TAP Block, the team performs a TAP-Block combined with a unique Morphinic spinal anesthesia preoperatively for cephalic duodenopancreatectomy (CDP). The objective of the study is to evaluate the effectiveness and safety of this change in practice.

Conditions

Pancreatic Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Major subject (≥18 years old)
• Planned cephalic or total duodeno-pancreatectomy surgery, associated or not with additional vascular procedures or liver resections by laparotomy, at the Strasbourg University Hospital for the period from June 1, 2022 to May 31, 2024.
• Subject who has not expressed opposition to the reuse of their data for scientific research purposes.

Exclusion Criteria

• Subject having expressed opposition to participating in the study
• Admission to intensive care following the operation
• Drug addiction withdrawn or not
• Surgery shortened by surgical decision

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service d'Anesthésiologie - Réanimation Chirurgicale - CHU de Strasbourg - France

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Martin PETIT, MD

Role: CONTACT

martin.petit@chru-strasbroug.fr

33 3 88 12 70 75

Facility Contacts

Martin PETIT, MD

Role: primary

martin.petit@chru-strasbroug.fr

33 3 88 12 70 75

Other Identifiers

9134

Identifier Type: -

Identifier Source: org_study_id