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Post-Operative Pain Management Following Spine Surgery (EXPAREL)

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ClinicalTrials.gov Identifier: NCT03076710
Recruitment Status : Recruiting
First Posted : March 10, 2017
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Pacira Pharmaceuticals, Inc
Information provided by (Responsible Party):
Steven Vanni, 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.

Condition or disease Intervention/treatment
Pain Management Analgesia Anesthetic Drug: Opioids delivered through PCA Drug: EXPAREL® infiltration

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Two-Stage, Pilot, Prospective, Observational Study of Post-Operative Pain Management Following Spine Surgery
Actual Study Start Date : July 31, 2017
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Group/Cohort Intervention/treatment
Opioids delivered through PCA
PCA devices used to deliver opioids
Drug: Opioids delivered through PCA
IV up to 1 mg. morphine every 10 minutes on request and oral opioids up to 2 tablets of Percocet every 4 hours

EXPAREL® infiltration
EXPAREL® infiltration at the site of surgery and nurse-administered opioid as needed
Drug: EXPAREL® infiltration
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
Other Names:
  • Bupivacaine
  • Marcaine




Primary Outcome Measures :
  1. Pain severity at the site of surgery [ Time Frame: 4 hours post surgery ]
    Numerical Rating Scale 0 (no pain) to 10 (worst pain imaginable).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing primary, single level, lumbar fusion surgical procedures.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076710


Contacts
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Contact: Karthik Madhavan, MBBS 3052436946 karthik.madhavan@jhsmiami.org

Locations
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United States, Florida
University of Miami Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Karthik Madhavan, MBBS       karthik.madhavan@jhsmiami.org   
Principal Investigator: Steven Vanni, DO, DC         
Sponsors and Collaborators
University of Miami
Pacira Pharmaceuticals, Inc
Investigators
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Principal Investigator: Steven Vanni, DO, DC University of Miami

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Responsible Party: Steven Vanni, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03076710     History of Changes
Other Study ID Numbers: 20140496
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Steven Vanni, University of Miami:
spine surgery
post-operative pain
patient controlled analgesia
Exparel®
bupivacaine
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotics
Analgesics