Liposomal Bupivacaine in Vaginal Hysterectomy

Phase 4TerminatedNCT03907033

Mayo Clinic28 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Vaginal Hysterectomy

Interventions

Liposomal bupivacaineDRUG

Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.

Bupivacaine HydrochlorideDRUG

We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Arizona

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Total Post-surgical Opioid Medication Use

Participants post-surgical analgesic medication use of IV hydrocodone and oxycodone measured in morphine equivalents (ME)

Time frame: First 72 hours following surgery completion

Total Post-surgical Analgesic Medication Use

Participants post-surgical analgesic medication use of Ibuprofen and acetaminophen measured in milligrams (mg)

Time frame: First 72 hours following surgery completion

Secondary Outcomes

Mean PACU Visual Analog Scale (VAS) (0-10) Pain Score

Scale Ranges from 0 (no pain) to 10 (extreme pain)

Time frame: Assessed while patient in PACU for recovery post-surgery per standard procedure

VAS Pain Score at 24, 48, and 72 Hours Post-surgery Completion

Scale Ranges from 0 (no pain) to 10 (extreme pain)

Time frame: 24, 48, and 72 hours post-surgery completion

Nausea at 24, 48, and 72 Hours Post-surgery Completion

Number of times patient reported feeling nauseous

Time frame: 24, 48, and 72 hours post-surgery

Emesis at 24, 48, and 72 Hours Post-surgery Completion

Number of times the patient vomited

Time frame: 24, 48, and 72 hours post-surgery

Urinary Retention

Number of patients who had post-void residual (PVR) \>150cc's at voiding trial prior to discharge

Time frame: At voiding trial prior to discharge from hospital, approximately 72 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.