Post-Operative Pain Management Following Spine Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain Management, Analgesia, Anesthetic

Intervention / Treatment
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* Drug: Opioids delivered through PCA
* Drug: EXPAREL® infiltration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Opioids delivered through PCA<br>PCA devices used to deliver opioids | Drug: Opioids delivered through PCA<br>* IV up to 1 mg. morphine every 10 minutes on request and oral opioids up to 2 tablets of Percocet every 4 hours<br>|
| EXPAREL® infiltration<br>EXPAREL® infiltration at the site of surgery and nurse-administered opioid as needed | Drug: EXPAREL® infiltration<br>* 22 gauge / 3.5 needle, into dermal/fascial/muscular/subcutaneous layers and up to 4mg IV morphine every 60 minutes on request and standardized oral opioids on request<br>* Other names: Marcaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain severity at the site of surgery | Numerical Rating Scale 0 (no pain) to 10 (worst pain imaginable). | 4 hours post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spine surgery, post-operative pain, patient controlled analgesia, Exparel®, bupivacaine