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NCT04603911 · ClinicalTrials.gov registry record · Phase 2

RCT Comparing ESPB Solutions in Breast Surgery

A Phase 2 study, sponsored by Tufts Medical Center.

Completed
Registry status
Phase 2
Development phase
75
Enrollment target

NCT04603911 is a Phase 2 study that has completed, run by Tufts Medical Center. The registered enrollment target is 75 participants.

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The verdict

NCT04603911, a Phase 2 study, has completed, sponsored by Tufts Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
75 participants
Enrollment target

Study Summary

The object of our research is to investigate the relative efficacy of liposomal bupivacaine administered via an Erector Spinae Plane (ESP) block as compared to our standard of care medication solution of (bupivacaine mixed with epinephrine, dexamethasone, and clonidine) for pain management in subjects undergoing bilateral surgical intervention for breast cancer. This will be an investigator-initiated, double-blind, patient-controlled, randomized control trial comparing pain scores at 48 hours after injection.

Interventions

  • DRUG Liposomal bupivacaine
  • DRUG Bupivacaine, epinephrine, dexamethasone, and clonidine

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2020-12-04
Est. Completion 2023-04-10
Phase Phase 2

Sponsor

Tufts Medical Center

169 total trials

What the Registry Record Tells You About NCT04603911

The ClinicalTrials.gov registry entry for NCT04603911 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tufts Medical Center, which has 169 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Liposomal bupivacaine is the first listed.

NCT04603911 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04603911 about?

NCT04603911 is a clinical study titled "RCT Comparing ESPB Solutions in Breast Surgery". The object of our research is to investigate the relative efficacy of liposomal bupivacaine administered via an Erector Spinae Plane (ESP) block as compared to our standard of care medication solution of (bupivacaine mixed with epinephrine, dexamethasone, and clonidine) for pain management in subjec...

What is the current status of trial NCT04603911?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2020-12-04. Estimated completion is 2023-04-10.

What interventions are being tested in trial NCT04603911?

The interventions under investigation include: Liposomal bupivacaine (DRUG), Bupivacaine, epinephrine, dexamethasone, and clonidine (DRUG).

Who is sponsoring clinical trial NCT04603911?

This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.