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Utility of Exparel Based ESP Blocks in Elective Posterior Spine Fusion

NCT06107660 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-10-30

No results posted yet for this study

Summary

The goal of this clinical trial is to compare two different medications used to reduce pain during lower back fusion surgery. The main questions this study aims to answer are:

1. Can liposomal bupivacaine, when included in a regional anesthesia technique called the Erector Spinae Plane block (ESPB), reduce opioid use post-operatively compared to the standard medication typically used in an ESPB (bupivacaine with stabilizing agents)?
2. Do patients report lower pain and better satisfaction with their surgery when they receive liposomal bupivacaine in the ESPB compared to those that receive the standard medication?

Participants will be randomized to into two groups one that receives liposomal bupivacaine and one group that receives bupivacaine with stabilizing agents. Other than the randomization all patients will follow current standard of care at our hospital, and will not be asked to complete any additional study forms in addition to forms currently asked of all patients as per standard of care.

Conditions

  • Spine Fusion
  • Anesthesia, Local

Interventions

DRUG

Liposomal bupivacaine

Patients will receive either liposomal bupivacaine as part of the ESPB .

DRUG

Bupivacaine

This is the control group comparator as this is standard of care at the investigator's institution.

Sponsors & Collaborators

  • Hartford Hospital

    lead OTHER

Principal Investigators

  • Heeren Makanji, MD · Hartford HealthCare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2025-06-30
Completion
2025-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06107660 on ClinicalTrials.gov