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

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.

Conditions

• Duodenal Neoplasm
• Pancreatic Neoplasm

Interventions

DRUG

Bupivacaine

Given via epidural and injection

DRUG

Hydromorphone

Given via epidural

DRUG

Iopamidol

Given via epidural

DRUG

Liposomal Bupivacaine

Given injection

OTHER

Medical Chart Review

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Thoracic Epidural Analgesia

Undergo thoracic epidural placement

PROCEDURE

Ultrasound Imaging

Undergo ultrasound

PROCEDURE

X-Ray Imaging

Undergo x-ray

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Masonic Cancer Center, University of Minnesota

  lead OTHER

Principal Investigators

• James Flaherty · University of Minnesota Masonic Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-10

Primary Completion

2027-01-01

Completion

2028-01-01

FDA Drug

Yes

Countries

• United States

Study Locations