RecruitingPhase 2NCT06411795

Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy

Rectus Sheath Block With Liposomal Bupivacaine Versus Thoracic Epidural Analgesia for Pain Control Following Pancreatoduodenectomy: A Prospective, Randomized, Non-Inferiority Trial


Sponsor

Masonic Cancer Center, University of Minnesota

Enrollment

78 participants

Start Date

Nov 10, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two pain control methods after a major pancreatic surgery called a Whipple procedure (pancreaticoduodenectomy). One method uses nerve blocks with a long-acting local anesthetic (liposomal bupivacaine), and the other uses a thoracic epidural (a tube in the back). Researchers want to find out which approach leads to better recovery. **You may be eligible if...** - You are 18 or older and scheduled for open Whipple surgery at the University of Minnesota **You may NOT be eligible if...** - You have a bleeding disorder, local anesthetic allergy, or skin infection at the injection site - You regularly use opioid pain medications (30mg morphine equivalent or more per day for 3+ weeks) - You have difficulty understanding recovery questionnaires - You are pregnant - You decline to participate in research Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBupivacaine

Given via epidural and injection

DRUGHydromorphone

Given via epidural

DRUGIopamidol

Given via epidural

DRUGLiposomal Bupivacaine

Given injection

OTHERMedical Chart Review

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

DRUGThoracic Epidural Analgesia

Undergo thoracic epidural placement

PROCEDUREUltrasound Imaging

Undergo ultrasound

PROCEDUREX-Ray Imaging

Undergo x-ray


Locations(1)

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States

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NCT06411795


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