Post-Operative Pain Management Following Spine Surgery (EXPAREL)

University of Miami

Status: Withdrawn

Conditions: Pain Management; Anesthetic; Analgesia

Treatments: Drug: Opioids delivered through PCA; Drug: EXPAREL® infiltration

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03076710

20140496

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Opioids delivered through PCA

Description:

PCA devices used to deliver opioids

Treatment:

Drug: Opioids delivered through PCA

EXPAREL® infiltration

Description:

EXPAREL® infiltration at the site of surgery and nurse-administered opioid as needed

Treatment:

Drug: EXPAREL® infiltration