Status:
TERMINATED
Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures
Lead Sponsor:
University of California, Irvine
Conditions:
Ovarian Cancer
Fibroids
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this research study is to find out which type of transversus abdomens plane (TAP) and block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) i...
Detailed Description
The purpose of this research study is to find out which type of TAP block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and low...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age ≥ 18 years old
- Must be undergoing an open gynecologic procedure through a midline vertical incision with a gynecologic oncologist
- Exclusion Criteria
- History of chronic pain
- History of opioid dependence
- Suspected or confirmed history of endometriosis
- History of fibromyalgia
- Suspected or confirmed interstitial cystitis or painful bladder syndrome
- History of or current opioid use prior to surgery
- Hypersensitivity to bupivacaine
- Severe hepatic or renal disease
Exclusion
Key Trial Info
Start Date :
May 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 13 2023
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04849858
Start Date
May 20 2019
End Date
January 13 2023
Last Update
August 23 2024
Active Locations (1)
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1
University of California, Irvine
Orange, California, United States, 92868