Post-Operative Pain Management Following Spine Surgery

Conditions:Chronic Pain, Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Age Range:18 - 65
Start Date:July 31, 2017
End Date:March 2022
Contact:Karthik Madhavan, MBBS

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Two-Stage, Pilot, Prospective, Observational Study of Post-Operative Pain Management Following Spine Surgery

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

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.

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

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
We found this trial at
1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
Principal Investigator: Steven Vanni, DO, DC
University of Miami Hospital The University of Miami changed the face of modern health care...
Miami, FL
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