Two-Stage, Pilot, Prospective, Observational Study of Post-Operative Pain Management Following Spine Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Opioids delivered through PCA
- Conditions
- Pain Management
- Sponsor
- University of Miami
- Locations
- 1
- Primary Endpoint
- Pain severity at the site of surgery
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
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.
Investigators
Steven Vanni
Associate Professor
University of Miami
Eligibility Criteria
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
Arms & Interventions
Opioids delivered through PCA
PCA devices used to deliver opioids
Intervention: Opioids delivered through PCA
EXPAREL® infiltration
EXPAREL® infiltration at the site of surgery and nurse-administered opioid as needed
Intervention: EXPAREL® infiltration
Outcomes
Primary Outcomes
Pain severity at the site of surgery
Time Frame: 4 hours post surgery
Numerical Rating Scale 0 (no pain) to 10 (worst pain imaginable).