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Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery

NCT00542542 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2015-04-13

Study results available
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Summary

Primary Objective:

To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased immediate post-operative pain compared with patients having only general anesthesia.

Secondary Objectives:

1. To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased post-operative pain in the first 24 hours after surgery compared with patients having only general anesthesia.
2. To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in decreased post-operative nausea and vomiting in the first 24 hours as compared with patients having only general anesthesia.
3. To determine whether the use of a paravertebral block in patients undergoing reconstructive surgery for breast cancer results in a decreased length of hospital stay compared with patients having only general anesthesia.

Conditions

Interventions

PROCEDURE

Paravertebral Block

Paravertebral block given as a bolus injection into the paravertebral space.

DRUG

Propofol

2-2.5 mg/kg IV over 1-4 hours during surgery.

DRUG

Fentanyl

50-250 mcg IV over 1-4 hours during surgery.

DRUG

Ropivacaine

Ropivacaine given by injection into the paravertebral space along the spinal canal.

DRUG

Midazolam

0.08 mg/kg IV over 1-4 hours during the surgery.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Farzin Goravanchi, MD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT00542542 on ClinicalTrials.gov