Deformity of Spine, Low Back Pain, Lumbar Disc Degeneration, Lumbar Disc Herniation, Lumbosacral Radiculopathy, Spondylolisthesis, Spondylolysis, Stenosis
Conditions
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.
Interventions
DRUGExparel
1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
DRUGBupivacaine
30 mL bupivacaine 0.5% w/v solution
Sponsors
Virtua Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Local Infiltration of EXPAREL and Bupivacaine 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 | 11 |
| Local Infiltration of Exparel Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL | 4 |
| Local Infiltration of Bupivacaine Bupivacaine: 30 mL bupivacaine 0.5% w/v solution | 4 |
| Total | 19 |
Baseline characteristics
| Characteristic | Local Infiltration of EXPAREL and Bupivacaine | Local Infiltration of Exparel | Local Infiltration of Bupivacaine | Total |
|---|---|---|---|---|
| Age, Continuous | 67.8 years | 72.3 years | 67.3 years | 68.6 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 7 Participants | 2 Participants | 2 Participants | 11 Participants |
| Sex: Female, Male Female | 6 Participants | 2 Participants | 2 Participants | 10 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 2 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 1 / 11 | 0 / 4 | 1 / 4 |
| serious Total, serious adverse events | 0 / 11 | 0 / 4 | 0 / 4 |
Outcome results
Primary
Mean Postoperative Pain Score
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
Population: Data is not collected for one patient in the Local infiltration of EXPAREL and Bupivacaine group
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Local Infiltration of EXPAREL and Bupivacaine | Mean Postoperative Pain Score | 5.2 units on a scale |
| Local Infiltration of Exparel | Mean Postoperative Pain Score | 4.2 units on a scale |
| Local Infiltration of Bupivacaine | Mean Postoperative Pain Score | 5.6 units on a scale |
Secondary
Mean Time to Achieve Physical Therapy Discharge
Mean time to achieve physical therapy discharge criteria
Time frame: last day of hospitalization, average of 3 days in hospital
Population: This data was not collected
Secondary
Number of Participants With Opioid Related Adverse Events
Number of Participants with Opioid Related Adverse Events
Time frame: last day of hospitalization, average of 3 days in hospital
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Local Infiltration of EXPAREL and Bupivacaine | Number of Participants With Opioid Related Adverse Events | 1 Participants |
| Local Infiltration of Exparel | Number of Participants With Opioid Related Adverse Events | 0 Participants |
| Local Infiltration of Bupivacaine | Number of Participants With Opioid Related Adverse Events | 1 Participants |
Secondary
Total Consumption of Opioids During Hospital Stay
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
Population: Data is not collected for one patient in the Local infiltration of EXPAREL and Bupivacaine group
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Local Infiltration of EXPAREL and Bupivacaine | Total Consumption of Opioids During Hospital Stay | 106.1 milligram |
| Local Infiltration of Exparel | Total Consumption of Opioids During Hospital Stay | 87.3 milligram |
| Local Infiltration of Bupivacaine | Total Consumption of Opioids During Hospital Stay | 46.1 milligram |