Liposomal Bupivacaine in Vaginal Hysterectomy

Phase 4

Terminated

Brief 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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivacaine	Liposomal bupivacaine	Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments
Standard Bupivacaine	Bupivacaine Hydrochloride	Patients in the control group will receive 0.25% bupivacaine hydrochloride (bupivacaine HCl). 10cc will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc of will be injected bilaterally into the deeper uterosacral ligaments.
Liposomal Bupivacaine	Bupivacaine Hydrochloride	Patients in the study group will receive a mixture of 0.5% bupivacaine HCl and liposomal bupivacaine in 1:1 ratio. 10cc of the mixture will be injected bilaterally into each uterosacral ligament prior to the colpotomy incision. After entry into the posterior cul-de-sac, an additional 10cc will be injected bilaterally into the deeper uterosacral ligaments

Primary Outcome Measures

Name	Time	Method
Total Post-surgical Opioid Medication Use	First 72 hours following surgery completion	Participants post-surgical analgesic medication use of IV hydrocodone and oxycodone measured in morphine equivalents (ME)
Total Post-surgical Analgesic Medication Use	First 72 hours following surgery completion	Participants post-surgical analgesic medication use of Ibuprofen and acetaminophen measured in milligrams (mg)

Secondary Outcome Measures

Name	Time	Method
Emesis at 24, 48, and 72 Hours Post-surgery Completion	24, 48, and 72 hours post-surgery	Number of times the patient vomited
Mean PACU Visual Analog Scale (VAS) (0-10) Pain Score	Assessed while patient in PACU for recovery post-surgery per standard procedure	Scale Ranges from 0 (no pain) to 10 (extreme pain)
Nausea at 24, 48, and 72 Hours Post-surgery Completion	24, 48, and 72 hours post-surgery	Number of times patient reported feeling nauseous
VAS Pain Score at 24, 48, and 72 Hours Post-surgery Completion	24, 48, and 72 hours post-surgery completion	Scale Ranges from 0 (no pain) to 10 (extreme pain)
Urinary Retention	At voiding trial prior to discharge from hospital, approximately 72 hours	Number of patients who had post-void residual (PVR) \>150cc's at voiding trial prior to discharge
Patient Satisfaction With Pain Management at 72 Hours and 7-10 Days Post Surgery	72 hours and 7-10 days post surgery	Assessed on 0-10 scale (0 being worst level of satisfaction, 10 being best level)