Post-Operative Pain Management Following Spine Surgery (EXPAREL)

Two-Stage, Pilot, Prospective, Observational Study of Post-Operative Pain Management Following Spine Surgery

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.

Study Overview

• Status: Withdrawn
• Conditions: Analgesia; Pain Management; Anesthetic
• Intervention / Treatment: 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 Type: Observational

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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: Marcaine; Bupivacaine

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Pacira Pharmaceuticals, Inc
• Investigators: Principal Investigator: Steven Vanni, DO, DC, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2017
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: March 6, 2017
• First Posted (Actual): March 10, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: bupivacaine; spine surgery; patient controlled analgesia; post-operative pain; Exparel®
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: 20140496

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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