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)
• Enrollment: 19
• Location: 1
• Arms: 3
• Actual Duration (Months): 37
• Patients Per Site Per Month: 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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain; Lumbosacral Radiculopathy; Lumbar Disc Degeneration; Lumbar Disc Herniation; Stenosis; Spondylolisthesis; Spondylolysis; Deformity of Spine	Drug: Exparel; Drug: Bupivacaine	Phase 4

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)

• Study Protocol and Statistical Analysis Plan - Oct 13, 2016

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: Intervertebral Disc Displacement; Spondylolisthesis; Intervertebral Disc Degeneration; Spondylolysis; Radiculopathy; Low Back Pain; Bupivacaine

Study Results

Participant Flow

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
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.