Post-Operative Pain Management Following Spine Surgery

NCT ID: NCT03076710

Last Updated: 2020-07-02

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-31
• Study Completion Date: 2022-03-31

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.

Conditions

Pain Management; Analgesia; Anesthetic

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Opioids delivered through PCA

PCA devices used to deliver opioids

Opioids delivered through PCA

Intervention Type: DRUG

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

EXPAREL® infiltration

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Bupivacaine; Marcaine

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Steven Vanni

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Vanni, DO, DC

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami Hospital

Miami, Florida, United States

Countries

United States

Other Identifiers

20140496

Identifier Type: -

Identifier Source: org_study_id