CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 89 enrolled
Drug / intervention
Propofol +4 moredrug
Likely dose
Propofol 2.5 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00542542
NCT00542542Phase 3Completed

Prospective Randomized Clinical Trial to Evaluate the Use of Paravertebral Blocks in Reconstructive Breast Surgery

M.D. Anderson Cancer Center·interventional·Posted Oct 11, 2007·Updated Apr 13, 2015

In Brief

A Phase 3 clinical trial evaluating Paravertebral Block, Propofol, and 3 other interventions for Breast Cancer. Completed, enrolled 89 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 11, 2007
Enrollment StartSep 1, 2007
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 18.7 years ago

Interventions

Paravertebral Blockprocedure

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

Propofoldrug

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

Fentanyldrug

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

Ropivacainedrug

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

Midazolamdrug

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