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Prevention of Post-Mastectomy Breast Pain Using Ambulatory Continuous Paravertebral Blocks

NCT01231204 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-04-11

No results posted yet for this study

Summary

Research study to determine if putting local anesthetic-or numbing medication-through a tiny tube placed next to the nerves that go to a breast prior to and following a mastectomy will decrease subsequent pain.

Conditions

Interventions

PROCEDURE

Placebo (normal saline) Continuous Infusion

Patients randomized to this group will receive an initial catheter placement using the standard Ultrasound-guided Technique. For the surgical procedure they will receive 15cc of 0.5%Ropivicaine. Following the surgical procedure they will receive a pain pump filled with normal saline. The normal saline infusion will continue for the 3 days following surgery. All patients will have access to other pain relievers for break-through pain. All patients will have the outcome measures assessed.

PROCEDURE

Ropivicaine 0.4% Continuous Infusion

Patients randomized to this group will receive an initial catheter placement using the standard Ultrasound-guided Technique. For the surgical procedure they will receive 15cc of 0.5%Ropivicaine. Following the surgical procedure they will receive a pain pump filled with 0.4%Ropivicaine. The 0.4%Ropivicaine infusion will continue for the 3 days following surgery. All patients will have access to other pain relievers for break-through pain. All patients will have the outcome measures assessed.

Sponsors & Collaborators

Principal Investigators

  • Brian M Ilfeld, M.D., M.S. · University of California, San Diego, Department of Anesthesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-11-30
Completion
2016-03-31

Countries

  • United States

Study Locations

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Diseases
Companies

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 NCT01231204 on ClinicalTrials.gov