Two-Stage, Pilot, Prospective, Observational Study of Post-Operative Pain Management Following Spine Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- University of Miami
- Locations
- 1
- Primary Endpoint
- Pain severity at the site of surgery
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Opioids delivered through PCA
PCA devices used to deliver opioids
Intervention: Opioids delivered through PCA (Drug)
EXPAREL® infiltration
EXPAREL® infiltration at the site of surgery and nurse-administered opioid as needed
Intervention: EXPAREL® infiltration (Drug)
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Steven Vanni
Associate Professor
University of Miami