Liposomal Bupivacaine in Vaginal Hysterectomy

Status Terminated

Clinical Trial 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.

Clinical Trial Description

Prior to surgery, patients are assigned by chance (like a coin toss) to receive either the bupivacaine HCl injection at the time of surgery or bupivacaine HCl plus liposomal bupivacaine. Patients and the Principal Investigator cannot choose the study group. Patients will have a 50% chance of being assigned to either group; however, regardless of which group they are assigned to, the medical record will show that they received liposomal bupivacaine. The injections will be given in the vaginal area when the patient is under anesthesia. After surgery, patients will be asked to record their pain, medication use, pain scores and symptoms in a diary for each 12 hour interval up to 72 hours. Someone will also call twice a day during the 72 hours after surgery to ask about pain level and pain medication use. Patients will also receive a phone call 7-10 days after the surgery to ask about their recovery and pain level. ;

Study Design

Related Conditions & MeSH terms

Vaginal Hysterectomy

Clinical Trial Details

NCT number	NCT03907033
Study type	Interventional
Source	Mayo Clinic
Contact
Status	Terminated
Phase	Phase 4
Start date	September 3, 2019
Completion date	July 23, 2021

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