Liposomal Bupivacaine in Vaginal Hysterectomy

Mayo Clinic

Status and phase: Terminated; Phase 4

Conditions: Vaginal Hysterectomy

Treatments: Drug: Liposomal bupivacaine; Drug: Bupivacaine Hydrochloride

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03907033

15-008413

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: Female

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 2 patient groups

Standard Bupivacaine

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine Hydrochloride

Liposomal Bupivacaine

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine Hydrochloride

Drug: Liposomal bupivacaine