Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion

NCT03745040 | Suspended Phase 4 DMC FDA Drug

• 1 other identifier: 1252230
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug.

Conditions

Lumbar Spinal Stenosis; Lumbar Disc Herniation; Lumbar Disc Disease; Lumbar Spondylolisthesis

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analog Pain Scores

  Change in Visual Analog Pain Scores over time; respondents report pain at incision site and at drain site on a scale of No pain (0) to Intolerable pain (10).

  Through study completion, an average of 2.5 days

Secondary Outcomes (6)

• Number of Participants with Pain

  Through study completion, an average of 2.5 days

• Discomfort

  Through study completion, an average of 2.5 days

• Total Opioid Consumption

  Through study completion, an average of 2.5 days

• Number of Opioid-related Adverse Events

  Through study completion, an average of 2.5 days

• Patient Cost of In-Hospital Stay

  Through study completion, an average of 2.5 days

Study Arms (2)

Group A: Exparel

EXPERIMENTAL

Standard of Care plus Liposomal bupivacaine (Exparel®). Dosage: Exparel® 20 mL single use vial, 1.3% (13.3 mg/mL), Maximum dose of 266 mg (20 mL). Frequency: Single intraoperative administration

Drug: Liposomal bupivacaine

Group B: No Exparel

NO INTERVENTION

Standard of Care

Interventions

Liposomal bupivacaine DRUG

20ml bupivacaine liposome injectable suspension 1.3% (266mg) + 50ml 0.25% Bupivacaine (150mg) + 70ml preservative-free 0.9% neutral saline

Also known as: Exparel

Group A: Exparel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a primary diagnosis of single-level lumbar stenosis, disc herniation, and/or spondylolisthesis excluding degenerative disc disease
• Receives open, one-level posterior spinal fusion

You may not qualify if:

• Is opioid-tolerant. Opioid tolerant patients are receiving, for one week or longer, at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid.
• Experienced intraoperative complications (i.e., a dural tear or durotomy). Intra- and post-operative data will be excluded from the analysis for these patients.
• Has severe liver disease. Bupivacaine is primarily metabolized in the liver via conjugation with glucuronic acid. Patients with liver disease, especially severe disease may be more susceptible to toxicity.
• Has severe renal disease. Bupivacaine and the metabolite are primarily excreted by the kidneys. Excretion can be significantly changed by urinary perfusion, the presence of renal disease, factors affecting urinary pH, and renal blood flow
• Is less than 18 years old.
• Is pregnant.
• Cannot read and speak English.

Sponsors & Collaborators

• Allina Health System: lead
• Twin Cities Spine Center: collaborator

Study Sites (2)

Abbott Northwestern Hospital, Allina Health System

Minneapolis, Minnesota, 55407, United States

Location

United Hospital, Allina Health System

Saint Paul, Minnesota, 55102, United States

Location

Related Publications (21)

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MeSH Terms

Conditions

Spinal Stenosis; Intervertebral Disc Displacement; Intervertebral disc disease; Spondylolisthesis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Spondylolysis; Spondylosis

Study Officials

• Christopher Alcala-Marquez, MD

  Allina Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects will be blinded and will not be informed if they received the study drug or not.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective randomized clinical trial with two cohorts: one experimental and one control.

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 19, 2018
• Study Start: January 26, 2019
• Primary Completion: September 20, 2021
• Study Completion (Estimated): August 1, 2028
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)