A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief

Sponsor
Virtua Health, Inc. (Other)
Overall Status
Terminated
CT.gov ID
NCT03514277
Collaborator
(none)
19
1
3
37
0.5

Study Details

Study Description

Brief Summary

The purpose of this study is to collect information about how patients feel when doctors manage their pain after lumbar spine surgery using a combination of EXPAREL® and bupivacaine injected into the lumbar spine at the end of surgery, compared to the patients that doctors use only EXPAREL® or bupivacaine to manage their pain. This information will help doctors determine which approach works best for patients who will receive surgery in their lumbar spine in the future.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Basic Science
Official Title:
Combined Administration of Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Analgesia in Posterior Lumbar Spine Surgery - A Prospective Randomized Study
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Local infiltration of EXPAREL and Bupivacaine

Drug: Exparel
1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL

Drug: Bupivacaine
30 mL bupivacaine 0.5% w/v solution

Active Comparator: Local infiltration of Exparel

Drug: Exparel
1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL

Active Comparator: Local infiltration of Bupivacaine

Drug: Bupivacaine
30 mL bupivacaine 0.5% w/v solution

Outcome Measures

Primary Outcome Measures

  1. Mean Postoperative Pain Score [last day of hospitalization, average of 3 days in hospital]

    Wong-Baker pain faces scale of 0-no pain, to 10-extreme pain

Secondary Outcome Measures

  1. Total Consumption of Opioids During Hospital Stay [last day of hospitalization, average of 3 days in hospital]

    All opioid analgesics will be converted into oral mg morphine equivalent to determine the total dose of opioids

  2. Mean Time to Achieve Physical Therapy Discharge [last day of hospitalization, average of 3 days in hospital]

    Mean time to achieve physical therapy discharge criteria

  3. Number of Participants With Opioid Related Adverse Events [last day of hospitalization, average of 3 days in hospital]

    Number of Participants with Opioid Related Adverse Events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Age 18 or older;

  2. Primary indication is low back pain, lumbosacral radiculopathy, lumbar disc degeneration, lumbar disc herniation, stenosis, spondylolisthesis, spondylolysis, or deformity requiring surgical intervention;

  3. Scheduled to undergo primary, 1 or 2 level, posterior lumbar laminectomy with or without fusion, discectomy with fusion, or fusion at Virtua Memorial Hospital;

  4. Willing to provide informed consent, participate in study, and comply with study protocol.

Exclusion Criteria:
  1. Hypersensitivity or allergy to local anesthetics;

  2. Pregnant or contemplating pregnancy prior to surgery;

  3. Previous surgery in lumbar spine (i.e. other than microdiscectomy);

  4. Prior treatment for alcohol, recreational drug, or opioid abuse;

  5. Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);

  6. Surgery involving more than 2 vertebral levels;

  7. Worker's compensation or personal injury related to lumbar spine (treatment outcomes may be affected by patient's personal interests [21]; could also run into potential issues with reimbursement).

  8. Lactating women

  9. Patients with end stage liver disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Virtua Memorial Hospital Mount Holly New Jersey United States 08060

Sponsors and Collaborators

  • Virtua Health, Inc.

Investigators

  • Principal Investigator: Robert Greenleaf, MD, Princpal Investigator

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Virtua Health, Inc.
ClinicalTrials.gov Identifier:
NCT03514277
Other Study ID Numbers:
  • VirtuaHealthExparel
First Posted:
May 2, 2018
Last Update Posted:
Jan 6, 2021
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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.:
Yes
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Local Infiltration of EXPAREL and Bupivacaine Local Infiltration of Exparel Local Infiltration of Bupivacaine
Arm/Group Description Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL Bupivacaine: 30 mL bupivacaine 0.5% w/v solution Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
Period Title: Overall Study
STARTED 11 4 4
COMPLETED 11 4 4
NOT COMPLETED 0 0 0

Baseline Characteristics

Arm/Group Title Local Infiltration of EXPAREL and Bupivacaine Local Infiltration of Exparel Local Infiltration of Bupivacaine Total
Arm/Group Description Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL Bupivacaine: 30 mL bupivacaine 0.5% w/v solution Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL Bupivacaine: 30 mL bupivacaine 0.5% w/v solution Total of all reporting groups
Overall Participants 11 4 4 19
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]
67.8
72.3
67.3
68.6
Sex: Female, Male (Count of Participants)
Female
6
54.5%
2
50%
2
50%
10
52.6%
Male
5
45.5%
2
50%
2
50%
9
47.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
Asian
0
0%
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
Black or African American
2
18.2%
2
50%
1
25%
5
26.3%
White
7
63.6%
2
50%
2
50%
11
57.9%
More than one race
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
2
18.2%
0
0%
1
25%
3
15.8%

Outcome Measures

1. Primary Outcome
Title Mean Postoperative Pain Score
Description Wong-Baker pain faces scale of 0-no pain, to 10-extreme pain
Time Frame last day of hospitalization, average of 3 days in hospital

Outcome Measure Data

Analysis Population Description
Data is not collected for one patient in the Local infiltration of EXPAREL and Bupivacaine group
Arm/Group Title Local Infiltration of EXPAREL and Bupivacaine Local Infiltration of Exparel Local Infiltration of Bupivacaine
Arm/Group Description Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL Bupivacaine: 30 mL bupivacaine 0.5% w/v solution Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
Measure Participants 10 4 4
Mean (Full Range) [units on a scale]
5.2
4.2
5.6
2. Secondary Outcome
Title Total Consumption of Opioids During Hospital Stay
Description All opioid analgesics will be converted into oral mg morphine equivalent to determine the total dose of opioids
Time Frame last day of hospitalization, average of 3 days in hospital

Outcome Measure Data

Analysis Population Description
Data is not collected for one patient in the Local infiltration of EXPAREL and Bupivacaine group
Arm/Group Title Local Infiltration of EXPAREL and Bupivacaine Local Infiltration of Exparel Local Infiltration of Bupivacaine
Arm/Group Description Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL Bupivacaine: 30 mL bupivacaine 0.5% w/v solution Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
Measure Participants 10 4 4
Mean (Full Range) [milligram]
106.1
87.3
46.1
3. Secondary Outcome
Title Mean Time to Achieve Physical Therapy Discharge
Description Mean time to achieve physical therapy discharge criteria
Time Frame last day of hospitalization, average of 3 days in hospital

Outcome Measure Data

Analysis Population Description
This data was not collected
Arm/Group Title Local Infiltration of EXPAREL and Bupivacaine Local Infiltration of Exparel Local Infiltration of Bupivacaine
Arm/Group Description Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL Bupivacaine: 30 mL bupivacaine 0.5% w/v solution Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
Measure Participants 0 0 0
4. Secondary Outcome
Title Number of Participants With Opioid Related Adverse Events
Description Number of Participants with Opioid Related Adverse Events
Time Frame last day of hospitalization, average of 3 days in hospital

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Local Infiltration of EXPAREL and Bupivacaine Local Infiltration of Exparel Local Infiltration of Bupivacaine
Arm/Group Description Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL Bupivacaine: 30 mL bupivacaine 0.5% w/v solution Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
Measure Participants 11 4 4
Count of Participants [Participants]
1
9.1%
0
0%
1
25%

Adverse Events

Time Frame Duration of patient's hospital stay, an average of three days
Adverse Event Reporting Description
Arm/Group Title Local Infiltration of EXPAREL and Bupivacaine Local Infiltration of Exparel Local Infiltration of Bupivacaine
Arm/Group Description Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL Bupivacaine: 30 mL bupivacaine 0.5% w/v solution Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL Bupivacaine: 30 mL bupivacaine 0.5% w/v solution
All Cause Mortality
Local Infiltration of EXPAREL and Bupivacaine Local Infiltration of Exparel Local Infiltration of Bupivacaine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/11 (0%) 0/4 (0%) 0/4 (0%)
Serious Adverse Events
Local Infiltration of EXPAREL and Bupivacaine Local Infiltration of Exparel Local Infiltration of Bupivacaine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/11 (0%) 0/4 (0%) 0/4 (0%)
Other (Not Including Serious) Adverse Events
Local Infiltration of EXPAREL and Bupivacaine Local Infiltration of Exparel Local Infiltration of Bupivacaine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/11 (9.1%) 0/4 (0%) 1/4 (25%)
Gastrointestinal disorders
Nausea 1/11 (9.1%) 1 0/4 (0%) 0 1/4 (25%) 1
Constitpation 1/11 (9.1%) 1 0/4 (0%) 0 0/4 (0%) 0
General disorders
lethargy 1/11 (9.1%) 1 0/4 (0%) 0 0/4 (0%) 0
Dehydration 1/11 (9.1%) 1 0/4 (0%) 0 0/4 (0%) 0
Unsteadiness 1/11 (9.1%) 1 0/4 (0%) 0 0/4 (0%) 0
Renal and urinary disorders
Urinary retention 1/11 (9.1%) 1 0/4 (0%) 0 0/4 (0%) 0
Respiratory, thoracic and mediastinal disorders
Hypoxia 1/11 (9.1%) 1 0/4 (0%) 0 1/4 (25%) 1

Limitations/Caveats

Early termination leading to small numbers of subjects analyzed

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Robert Greenleaf
Organization Reconstructive Orthopedics
Phone 609-267-9400
Email bob.greenleaf1@gmail.com
Responsible Party:
Virtua Health, Inc.
ClinicalTrials.gov Identifier:
NCT03514277
Other Study ID Numbers:
  • VirtuaHealthExparel
First Posted:
May 2, 2018
Last Update Posted:
Jan 6, 2021
Last Verified:
Dec 1, 2020