Post-Operative Pain Management Following Spine Surgery

NCT03076710 | Withdrawn FDA Drug

• 1 other identifier: 20140496
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management; Analgesia; Anesthetic

Keywords

spine surgery; post-operative pain; patient controlled analgesia; Exparel®; bupivacaine

Outcome Measures

Primary Outcomes (1)

• Pain severity at the site of surgery

  Numerical Rating Scale 0 (no pain) to 10 (worst pain imaginable).

  4 hours post surgery

Study Arms (2)

Opioids delivered through PCA

PCA devices used to deliver opioids

Drug: Opioids delivered through PCA

EXPAREL® infiltration

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

Drug: EXPAREL® infiltration

Interventions

Opioids delivered through PCA DRUG

IV up to 1 mg. morphine every 10 minutes on request and oral opioids up to 2 tablets of Percocet every 4 hours

Opioids delivered through PCA

EXPAREL® infiltration DRUG

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

Also known as: Bupivacaine, Marcaine

EXPAREL® infiltration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing primary, single level, lumbar fusion surgical procedures.

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

Sponsors & Collaborators

• University of Miami: lead
• Pacira Pharmaceuticals, Inc: collaborator

Study Sites (1)

University of Miami Hospital

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Steven Vanni, DO, DC

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 10, 2017
• Study Start: July 31, 2017
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)