Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-01-11 @ 3:04 PM
Study NCT ID:
NCT06499792
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of the Transversus Abdominis Plane Block Associated With Opioid Spinal Anesthesia on Analgesia After Cephalic Duodenopancreatectomy
Sponsor:
University Hospital, Strasbourg, France
Organization:
Study Overview
Official Title:
Effectiveness of the Transversus Abdominis Plane Block (TAP-Block) Associated With Opioid Spinal Anesthesia on Analgesia After Cephalic Duodenopancreatectomy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DPC-RATAP
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: