Post-Operative Pain Management Following Spine Surgery

Withdrawn before enrolling

Conditions studied: Pain Management, Analgesia, Anesthetic

In brief

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.

Key facts

Study ID

NCT03076710

Run by

University of Miami

People needed

0

Starts

2017-07-31

Expected to finish

2022-03-01

Last updated by the study team

2020-07-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Miami Hospital — Miami, Florida, United States

Full record on ClinicalTrials.gov

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