Randomized Trial of Wound Infiltration With Extended-release Bupivacaine Before Laparoscopic or Robotic Hysterectomy

September 10, 2020 updated by: AdventHealth

A Randomized Controlled Trial of Wound Infiltration With Extended-release Versus Short-acting Bupivacaine Before Laparoscopic or Robotic Hysterectomy

The investigators are studying ways to improve pain control after surgery. One way to decrease pain is to inject incisions with a numbing medicine (local anesthetic) while in the operating room. There is an FDA approved extended-release version of a commonly used local anesthetic (bupivacaine) that can last for 4 days instead of 6 hours. The investigators are studying whether using the extended-release medication (Exparel) will give better pain relief after laparoscopic and robotic-assisted hysterectomies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lidocaine and bupivacaine hydrochloride (HCl) are the most commonly used drugs for wound infiltration during laparoscopic surgery for post-operative pain control. There is some evidence that wound infiltration decreases immediate post-operative pain. While bupivacaine has a slightly slower onset of action (5-10 minutes), it has become the preferred injectable anesthetic for surgical use because of its longer duration of effect (4-8 hours versus 1-2 hours for lidocaine).

DepoFoam bupivacaine (EXPAREL, Pacira Pharmaceuticals, Inc., Parsippany, NJ, USA) is a newer extended-release formulation of bupivacaine HCl approved by the U.S. Federal Drug Administration in October 2011. In this suspension, bupivacaine is encapsulated in microscopic spherical lipid-based particles of varying size to allow dispersion of the drug over an extended period of time. Analgesia is prolonged up to 96 hours. Given the extended duration of action, this liposomal bupivacaine may be better at providing post-operative pain relief in laparoscopic surgery.

Phase three trials have shown better pain control in the first 24 hours and less opioid use overall in bunionectomies, hemorrhoidectomies, and total knee replacement surgery when compared to placebo. No studies, however, have been published evaluating extended-release liposomal bupivacaine for laparoscopic surgery, or gynecologic surgery in general. Currently, we are using liposomal bupivacaine for pain relief after laparoscopic hysterectomies, but as stated, it has never been formally evaluated.

We hypothesize that liposomal bupivacaine ("extended-release") provides extended pain relief and decreases the need for supplemental opioid use after major laparoscopic surgery. We will be evaluating whether pre-incision infiltration of extended-release bupivacaine decreases post-operative pain from laparoscopic and robotic-assisted hysterectomy compared to bupivacaine HCl ("short-acting"). To achieve this evaluation we designed a double-blinded randomized controlled trial.

Patients who are scheduled to undergo a laparoscopic or robotic-assisted hysterectomy will be invited to participate. Group A will receive pre-incision infiltration of each trocar site with 4 ml of 0.25% Bupivacaine HCl. Group B will receive pre-incision infiltration of each trocar site with 4 ml of extended-release bupivacaine (EXPAREL) (13.3mg/ml). Subjects and outcome assessors will be blinded to group allocation.

Data will be collected while patients are in the hospital on pain levels and consumption of opioid pain medications. Upon discharge, pain levels, functioning, and quantity of opioid and non-steroidal anti-inflammatory (NSAID) pain medications will be collected through online questionnaires. Subjects will be followed until their 2-3 weeks post-operative visit.

Study Type

Interventional

Enrollment (Actual)

64

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
    • Florida
      • Orlando, Florida, United States, 32804
        • Florida Hospital Orlando

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 and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Benign indication for surgery
  2. Planned multiport laparoscopic or robotic assisted hysterectomy
  3. Non-pregnant
  4. Able to provide informed consent
  5. Owns smartphone or computer with internet access
  6. Willing to provide contact phone number and accept SMS text messages
  7. Ability to speak and read English (because texts and online surveys will be in English only)

Exclusion Criteria:

  1. Planned additional procedures (e.g. incontinence surgery, prolapse repair or bowel surgery)

  2. Contraindication to study drug

    1. Severe Hepatic disease
    2. Severe Kidney disease
    3. Current use of monoamine oxidase inhibitors
    4. Current use of tricyclic antidepressants
  3. History of substance or alcohol abuse within the past 2 years

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Liposomal Bupivacaine
extended-release bupivacaine (EXPAREL)
Drug: Liposomal Bupivacaine
pre-incision infiltration with liposomal bupivacaine
Other Names:
  • Exparel
ACTIVE_COMPARATOR: Bupivacaine HCl
short-acting bupivacaine
Drug: Bupivacaine HCl
pre-incision infiltration with bupivacaine HCl
Other Names:
  • Marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numerical Rating Scale (NRS) Post-operative Pain Score on Post-Operative Day 1 (POD1).
Time Frame: 24 hours
Numerical Rating Scale (0-10) post-operative pain score on POD1, where 0 = no pain and 10 = worst pain imaginable
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS Pain Score at 2 Hours
Time Frame: 2 hours post-op
numeric rating scale (0-10), mean and SD, where 0 = no pain and 10 = worst pain imaginable
2 hours post-op
NRS Pain Score at 4 Hours
Time Frame: 4 hours post-op
Pain scale measured from 0-10, where 0 = no pain and 10 = worst pain imaginable
4 hours post-op
NRS Pain Score at 8 Hours
Time Frame: 8 hours post-op
Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable
8 hours post-op
NRS Pain Score at 16 Hours
Time Frame: 16 hours post-op
Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable
16 hours post-op
NRS Pain Score Post-op Day 2
Time Frame: 2 days post-op
Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable
2 days post-op
NRS Pain Score Post-op Day 3
Time Frame: 3 days post-op
Pain scale, where 0 = no pain and 10 = worst pain imaginable
3 days post-op
NRS Pain Score Post-op Day 14
Time Frame: Post-Operative Day 14
Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable
Post-Operative Day 14
Quality of Life as Measured by the Brief Pain Inventory (BPI)
Time Frame: Post-Operative Day 2
The brief pain inventory scale uses the 0 to 10 numerical rating scale to measure pain intensity under four different conditions. On the four conditions 0 = no pain, no relief, and does not interfere, whereas 10 = pain as bad as you can imagine, complete relief, and completely interferes
Post-Operative Day 2
Quality of Life as Measured by the Brief Pain Inventory (BPI)
Time Frame: Post-Operative Day 3
The brief pain inventory scale uses the 0 to 10 numerical rating scale to measure pain intensity under four different conditions. On the four conditions 0 = no pain, no relief, and does not interfere, whereas 10 = pain as bad as you can imagine, complete relief, and completely interferes
Post-Operative Day 3
Quality of Life as Measured by the Brief Pain Inventory (BPI)
Time Frame: Post-Operative Day 14
at time of post-op visit The brief pain inventory scale uses the 0 to 10 numerical rating scale to measure pain intensity under four different conditions. On the four conditions 0 = no pain, no relief, and does not interfere, whereas 10 = pain as bad as you can imagine, complete relief, and completely interferes
Post-Operative Day 14
Total Opioid Use Prior to Hospital Discharge
Time Frame: 24 hours
Oral morphine equivalent of opioid use while in the hospital
24 hours
Total Opioid Use End of Post-op Day 3
Time Frame: 72 hrs post-op
Total use of home opioids by pill count/ oral morphine equivalents
72 hrs post-op
Total Opioid Use at Post-op Day 14
Time Frame: Post-Operative Day 14
Total use of home opioids by pill count/ oral morphine equivalents
Post-Operative Day 14
Number of Participants With Adverse Events
Time Frame: Post-Operative Day 14
Post-Operative Day 14

Collaborators and Investigators

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

Sponsor

AdventHealth

Investigators

  • Principal Investigator: Georgine Lamvu, MD, MPH, Florida Hospital Orlando
  • Study Director: Kenneth I Barron, MD, Florida Hospital Orlando

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

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

July 1, 2015

Primary Completion (ACTUAL)

January 1, 2016

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

January 27, 2015

First Submitted That Met QC Criteria

January 30, 2015

First Posted (ESTIMATE)

February 2, 2015

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 691275

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There is not a plan to make IPD available, but aggregate data can be made available to interested correspondents

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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