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Serratus Anterior Plane Block in Patients Undergoing Mastectomy

NCT03154658 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2021-03-16

Study results available
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Summary

This is a randomized, interventional prospective study. Patients (n=66) undergoing mastectomies with or without tissue expander will be randomized to receive a supra-serratus or sub-serratus regional plane block prior to surgery. The main effect to be measured is total opioid consumption 24 hours after the operation. Secondary endpoints include measuring a change between pre-and post-operative pain scores, patient satisfaction of pain control during first 24 hours after the operation, presence of postoperative nausea and vomiting, duration of sleep on first postoperative night, and block performance time and length of stay, between the two treatment arms.

Conditions

  • Pain, Post-operative

Interventions

DRUG

Ropivacaine 0.35%

The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Anthony Machi, MD · UT Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2020-03-01
Completion
2020-03-01
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 NCT03154658 on ClinicalTrials.gov