Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures

Phase 3

Terminated

• Conditions: Ovarian Cancer; Fibroids; Uterine Cancer

• Registration Number: NCT04849858
• Lead Sponsor: University of California, Irvine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-4-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Terminated
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria<br><br> - Age = 18 years old<br><br> - Must be undergoing an open gynecologic procedure through a midline vertical incision<br> with a gynecologic oncologist<br><br>Exclusion Criteria<br><br> - History of chronic pain<br><br> - History of opioid dependence<br><br> - Suspected or confirmed history of endometriosis<br><br> - History of fibromyalgia<br><br> - Suspected or confirmed interstitial cystitis or painful bladder syndrome<br><br> - History of or current opioid use prior to surgery<br><br> - Hypersensitivity to bupivacaine<br><br> - Severe hepatic or renal disease

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-operative opioid consumption

Secondary Outcome Measures

Name	Time	Method
Pain at rest and during activity;Nausea/Vomiting;Ileus;Bowel Function;Ambulation;Hospital stay;Surgical Adverse Events