Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411795
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-08
Brief Title:
Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy A Prospective Randomized Non-Inferiority Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
This phase II trial compares the effect of rectus sheath block with liposomal bupivacaine to thoracic epidural analgesia TEA on pain control in patients following surgical removal of all or part of the pancreas and duodenectomy pancreatoduodenectomy Administering long acting local anesthetics such as liposomal bupivacaine in between the muscle layers of the abdomen rectus sheath block may help with pain relief during and after surgery TEA uses a needle to insert a flexible plastic catheter into the thoracic spine to administer anesthetic and pain medication such as bupivacaine and hydromorphone to treat pain in the thoracic and upper abdominal areas during and after surgery Epidurals have been successfully used to treat pain after surgery however it does have a risk of low blood pressure which may limit the use in the thoracic approach Rectus sheath blocks with liposomal bupivacaine may be as effective as TEA in reducing pain in patients following a pancreatoduodenectomy
Detailed Description:
PRIMARY OBJECTIVE
I To determine if rectus sheath blocks with liposomal bupivacaine provide non-inferior analgesia compared with thoracic epidural analgesia TEA for patients undergoing pancreatoduodenectomy
OUTLINE Patients are randomized to 1 of 2 groups
GROUP EPIDURAL E Prior to pancreatoduodenectomy patients undergo thoracic epidural placement and receive bupivacaine and hydromorphone continuous infusion via epidural for up to 72 hours postoperatively Patients also receive iopamidol via epidural and undergo x-ray imaging on study
GROUP RECTUS SHEATH RS Prior to pancreatoduodenectomy patients undergo ultrasound and receive bupivacaine and liposomal bupivacaine injection into the rectus sheath
I To determine if rectus sheath blocks with liposomal bupivacaine provide non-inferior analgesia compared with thoracic epidural analgesia TEA for patients undergoing pancreatoduodenectomy
OUTLINE Patients are randomized to 1 of 2 groups
GROUP EPIDURAL E Prior to pancreatoduodenectomy patients undergo thoracic epidural placement and receive bupivacaine and hydromorphone continuous infusion via epidural for up to 72 hours postoperatively Patients also receive iopamidol via epidural and undergo x-ray imaging on study
GROUP RECTUS SHEATH RS Prior to pancreatoduodenectomy patients undergo ultrasound and receive bupivacaine and liposomal bupivacaine injection into the rectus sheath
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-02287 | REGISTRY | None | None |
| ANES-2023-31918 | OTHER | None | None |
| P30CA077598 | NIH | University of MinnesotaMasonic Cancer Center | httpsreporternihgovquickSearchP30CA077598 |