Effectiveness Of The Transversus Abdominis Plane Block Associated With Opioid Spinal Anesthesia On Analgesia After Cephalic Duodenopancreatectomy

Study Overview

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

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.

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Pancreatic Cancer

9134

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-07-05	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-07-05
First Submitted that Met QC Criteria 2024-07-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-07-12
First Posted (ACTUAL) 2024-07-12	Results First Posted N/A	Last Verified 2024-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Consumption of Morphine in the first 24 hours postoperatively.	Quantitative variables are described using the usual position and dispersion statistics, namely mean, median, minimum, maximum, standard deviation and quantile. The qualitative variables are described with the numbers and proportions of each modality. The Chi2 test will be used to study the crossover between several qualitative variables. The risk of the first kind is set at 5% for all analyses.	Up to 1 year

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Martin PETIT, MD

Phone Number: 33 3 88 12 70 75

Email: martin.petit@chru-strasbroug.fr

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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