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Serratus Anterior Muscle Plane Block vsThoracic Paravertebral Block For Unilateral Mastectomies

NCT02822196 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2020-09-16

No results posted yet for this study

Summary

HYPOTHESIS

Serratus Anterior Muscle Plane Block (SPB) is as effective as thoracic paravertebral block (PVB) for acute pain control after unilateral mastectomies.

SPECIFIC AIMS

Primary aim: To evaluate the efficacy of SPB block vs thoracic PVB for acute pain control in patients undergoing unilateral mastectomy

Secondary aim To compare the onset and duration of block and dermatomes blocked in both groups To compare the need of post-operative rescue analgesia in both groups. To compare the development of chronic incisional pain in both groups Functional outcome with respect to daily activities.

Conditions

  • Breast Cancer
  • Mastectomy
  • Regional Anesthesia
  • Post Operative Pain

Interventions

DRUG

Lidocaine

Local Anesthesia using 1% Lidocaine

DRUG

Bupivacaine

Local Anesthesia using 0.25% Bupivacaine

Sponsors & Collaborators

  • Memorial Hermann Hospital

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Sara Guzman-Reyes, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-12-31
Primary Completion
2019-12-31
Completion
2019-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02822196 on ClinicalTrials.gov