EXPAREL: Post-Operative Pain Management Following Spine Surgery

Sponsor

University of Miami (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03076710

Collaborator

Pacira Pharmaceuticals, Inc (Industry)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Actual Enrollment :

0 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 :

Jul 31, 2017

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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