Liposomal Bupivacaine in One-level Instrumented Posterior Spinal Fusion

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving the drug. It is a prospective, randomized clinical trial with two cohorts: Group A: standard of care (SOC) plus liposomal bupivacaine (n=30) and Group B: SOC (n=30). All subjects will undergo open single-level posterior decompression and instrumented fusion for degenerative spondylolisthesis. The surgery is not an experimental procedure. Prior to closing the surgical wound, liposomal bupivacaine will be administered to Group A. The administration of the drug is a study procedure, but note that this is an indicated use of the drug. Postoperatively, subjects will be assessed for pain and opioid consumption. The investigator's hypothesis for statistical analysis is that there will be a 30% decrease in pain medication requirement for the experimental group (Group A: Liposomal bupivacaine ) versus the control group (Group B: No Liposomal bupivacaine). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03745040
Study type	Interventional
Source	Allina Health System
Contact	John M Dawson, PhD
Phone	612-775-6233
Email	jmdawson@tcspine.com
Status	Recruiting
Phase	Phase 4
Start date	January 26, 2019
Completion date	May 2024

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