Analgesia, Anesthetic, Pain Management
Conditions
Keywords
spine surgery, post-operative pain, patient controlled analgesia, Exparel®, bupivacaine
Brief summary
The primary objective of this pilot study is to assess the feasibility of comparing two standardized approaches to manage post-operative pain following spine surgery: one approach using Patient Controlled Analgesia (PCA) devices to deliver opioid analgesics, and the other approach using EXPAREL® infiltration at the site of surgery and nurse-administered opioid analgesics.
Detailed description
The study will assess the feasibility of the methods proposed, including recruitment, eligibility, standardization of both post-operative pain management approaches, and assessment of clinical, hospital efficiency, medication use, health services use, and economic outcomes.
Interventions
DRUGOpioids delivered through PCA
IV up to 1 mg. morphine every 10 minutes on request and oral opioids up to 2 tablets of Percocet every 4 hours
DRUGEXPAREL® infiltration
22 gauge / 3.5 needle, into dermal/fascial/muscular/subcutaneous layers and up to 4mg IV morphine every 60 minutes on request and standardized oral opioids on request
Sponsors
Pacira Pharmaceuticals, Inc
University of Miami
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-65 * Ability to speak, read, and write in English or Spanish * Primary indication is low back pain, radiculopathy, disc degeneration, disc herniation, foraminal stenosis, or mild 1-level spondylolisthesis or deformity * Scheduled to undergo primary, single level, lumbar fusion surgical procedure at the study center in the next 30 days * Willing to provide informed consent, participate in study, and comply with study protocol
Exclusion criteria
* Body mass index \>35 * Pregnant or contemplating pregnancy prior to surgery * Current or previous psychiatric, behavioral, or emotional disorder that may interfere with postsurgical pain, analgesia, or opioid use according to treating surgeon * Prior treatment for alcohol, recreational drug, or opioid abuse * Chronic inflammatory conditions (e.g. Crohn's, lupus, rheumatoid arthritis) * Chronic neurologic conditions (e.g. multiple sclerosis, Parkinson's) * Serious spinal conditions (e.g. cauda equina syndrome, infection, tumor, fracture) * Hypersensitivity or allergy to local anesthetics * Previous surgery in lumbar spine (i.e. other than microdiscectomy); * Continuous (e.g. daily) opioid consumption for more than 30 days prior to surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain severity at the site of surgery | 4 hours post surgery | Numerical Rating Scale 0 (no pain) to 10 (worst pain imaginable). |
Countries
United States
Outcome results
None listed