Liposomal Bupivacaine in Vaginal Hysterectomy

September 20, 2021 updated by: Johnny Yi, Mayo Clinic

Preemptive Local Analgesia With Liposomal Bupivacaine in Vaginal Hysterectomy: A Randomized Controlled Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic in Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard Bupivacaine
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.
Drug: Bupivacaine Hydrochloride
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.
EXPERIMENTAL: 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
Drug: Bupivacaine Hydrochloride
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.
Drug: Liposomal bupivacaine
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.
Other Names:
  • Exparel

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Pacira Pharmaceuticals, Inc

Investigators

  • Principal Investigator: Jeffrey L Cornella, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 3, 2019

Primary Completion (ACTUAL)

July 23, 2021

Study Completion (ACTUAL)

July 23, 2021

Study Registration Dates

First Submitted

April 5, 2019

First Submitted That Met QC Criteria

April 5, 2019

First Posted (ACTUAL)

April 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 15, 2021

Last Update Submitted That Met QC Criteria

September 20, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-008413

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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