Post-Operative Pain Management Following Spine Surgery

Withdrawn

• Conditions: Pain Management; Analgesia; Anesthetic
• Interventions: Drug: EXPAREL® infiltration; Drug: Opioids delivered through PCA

• Registration Number: NCT03076710
• Lead Sponsor: University of Miami

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-02-24
• Study First Submitted QC: 2017-03-06
• Study First Posted: 2017-03-10
• Study Start: 2017-07-31
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-30
• Last Update Posted: 2020-07-02
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EXPAREL® infiltration	EXPAREL® infiltration	EXPAREL® infiltration at the site of surgery and nurse-administered opioid as needed
Opioids delivered through PCA	Opioids delivered through PCA	PCA devices used to deliver opioids

Primary Outcome Measures

Name	Time	Method
Pain severity at the site of surgery	4 hours post surgery	Numerical Rating Scale 0 (no pain) to 10 (worst pain imaginable).

Trial Locations

Locations (1)

University of Miami Hospital; 🇺🇸 Miami, Florida, United States