drugset / Trial / NCT00542542

Evaluate the Use of Paravertebral Block in Reconstructive Breast Surgery

NCT00542542

Phase 3 Completed 89 enrolled M.D. Anderson Cancer Center
RandomizedParallel-groupOpen-labelDiagnostic

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.

Timeline

Start
2007-09
Primary completion
2014-03
Completion
2014-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fentanyl Other / unclassified 50 ug Intravenous
Comparator Fentanyl Other / unclassified 250 ug Intravenous
Comparator Midazolam Small molecule 0.08 mg/kg Intravenous
Comparator Propofol Small molecule 2 mg/kg Intravenous
Comparator Propofol Small molecule 2.5 mg/kg Intravenous
Comparator Ropivacaine Other / unclassified Other

Indications