Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in Erector Spinae Plane Blocks for Mastectomies

NCT06252662 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-11-19

No results posted yet for this study

Summary

Perform a comparison of effective pain relief duration between liposomal bupivacaine and dexmedetomidine when added to bupivacaine in a block for mastectomy for cancer surgery. The erector spinae plane block is a well-established block that is utilized for post operative pain control for procedures performed on the soft tissue of the chest and chest wall as well as intrathoracic procedures. The goal is comparison of the effective duration of both study groups to determine if there is a significant difference in time and amount of post operative opioids required which admitted to hospital.

Conditions

Interventions

DRUG

Dexmedetomidine

block duration extension additive

DRUG

Liposomal bupivacaine

Control arm, comparison for block duration with dexmedetomidine

Sponsors & Collaborators

  • United States Naval Medical Center, Portsmouth

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2025-07-31
Completion
2025-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT06252662 on ClinicalTrials.gov