Liposomal Bupivacaine in Vaginal Hysterectomy

• Status: Terminated
• Trial end date: 2021-07-23
• Target enrollment: 0
• Participant gender: Female

Summary

The aim of this study is to compare the effects of preemptive analgesia using liposomal bupivacaine mixed with bupivacaine HCl, versus bupivacaine HCl alone for uterosacral ligament injection in patients undergoing vaginal hysterectomy. We hypothesize that the group receiving a combination of liposomal bupivacaine and bupivacaine HCl will report superior postoperative pain management. Enhancement in pain control should confer a decrease in opioid and other analgesic medication requirements, which may contribute to decreased nausea, vomiting, and higher overall patient satisfaction with pain control.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: Pacira Pharmaceuticals, Inc
• Treatments: Bupivacaine

Criteria

INCLUSION CRITERIA

1. Women 18-85 who will be having an outpatient vaginal hysterectomy with or without concurrent prolapse repair surgery at Mayo Clinic Hospital in Arizona

EXCLUSION CRITERIA

1. Known history of hepatic (liver) disease as evidenced by an AST or ALT that is greater than normal values

2. Known history of renal (kidney) disease as evidenced by a serum creatinine that is greater than normal values

3. Known history of prolonged QT (QTc greater than 500 m/s)

4. Opiate tolerance as noted by daily use of greater than 20 mg morphine daily oral equivalents per day for a minimum of 1 month prior to surgery

5. Allergy or contraindication to amide local anesthetics, celecoxib, ketorolac, NSAIDs, acetaminophen, gabapentin, sulfa drugs, or ondansetron

6. Allergy to both oxycodone and hydromorphone

7. Patients with acute gastrointestinal bleed that has occurred less than 6 months prior to study enrollment

8. Adults lacking the ability to consent