Thoracic Epidural Analgesia vs Surgical Site Infiltration With Liposomal Bupivacaine Following Open Gynecologic Surgery

  • STATUS
    Recruiting
  • End date
    Jun 25, 2024
  • participants needed
    100
  • sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Updated on 25 May 2022
Accepts healthy volunteers

Summary

The goal of this study is to test the hypothesis that surgical site infiltration with liposomal bupivacaine (LB) is non-inferior to and more cost effective than thoracic epidural analgesia (TEA) for patients undergoing open gynecologic surgery on an established enhanced recovery program (ERP) using a non-inferiority randomized trial design. The impact of TEA and surgical site infiltration with LB on neuroendocrine and inflammatory mediators of surgical stress response (SSR) will also be investigated as a translational endpoint.

Details
Condition Surgery, Analgesia
Treatment Liposomal bupivacaine, Thoracic epidural analgesia (bupivacaine)
Clinical Study IdentifierNCT04117074
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Last Modified on25 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Individuals ≥ 18 years of age
Planned laparotomy by the gynecologic oncology service at the sponsor institution

Exclusion Criteria

Individuals who have a contraindication to thoracic epidural analgesia
Individuals with a coagulation disorder
Individuals with an infection at the site of epidural placement
Individuals with intracranial pathology such as non-communicating increased intracranial pressure or obstruction of cerebrospinal fluid flow related to mass lesions
Individuals with spinal pathology: abnormal spine anatomy, surgical fusion, or spinal column lesions
Individuals who have a contraindication to liposomal bupivacaine
Individuals with a known allergic reaction to liposomal bupivacaine
Individuals with Childs-Pugh Class B or C liver disease
Individuals who have a history of long-term opioid use for chronic pain, defined as use of opioid pain medications for ≥4 weeks prior to surgery
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