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Serratus Plane Block for Postoperative Pain Control

NCT02865928 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-02-22

Study results available
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Summary

This is a randomized, double-blinded, placebo-controlled trial of serratus plane blocks in subjects undergoing outpatient unilateral or bilateral breast surgery. Ninety subjects will be enrolled into the study at presurgical testing. Subjects will be stratified based on surgery type and randomized to receive a serratus plane block with either bupivicaine HCL or placebo. All patients will receive standard intraoperative anesthesia and standard postoperative pain control. The primary endpoint is the amount of opioid administered postoperatively. Secondary endpoints include postoperative pain intensity at timed intervals, amount of opioid administered intraoperatively and postoperatively, incidence of nausea and vomiting, time to discharge and patient satisfaction

Conditions

  • Outpatient Breast Surgery
  • Mastopexy
  • Augmentation
  • Revision

Interventions

DRUG

Bupivicaine HCl

Ultrasound guided serratus plane block with bupivicaine

DRUG

Normal Saline

Same injection technique as intervention arm with normal saline

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

  • Judith Aronsohn, MD · Northwell Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-05
Primary Completion
2019-11-25
Completion
2019-11-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02865928 on ClinicalTrials.gov