A Phase II/III Study of Continuous Local Anesthetic Infusion in Median Sternotomy Following Cardiac Surgery
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase II/III Study of Continuous Local Anesthetic Infusion in Median Sternotomy Following Cardiac Surgery|
- Visual analog pain [ Time Frame: 64 hours ]
- drug toxicity [ Time Frame: 64 hours ]
- infection [ Time Frame: 64 hours ]
- narcotic usage [ Time Frame: 64 hours ]
|Study Start Date:||July 2005|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
Ropivicaine infusion into the sternal wound
0.3% ropivacaine infusion at 4 ml/hr for 64 hours.
Placebo Comparator: 2
Normal saline infusion into the sternal wound
Drug: Normal saline
Normal saline infusion at 4 ml/hour for 64 hours.
Cardiac surgery is associated with pain in the post-operative period. Recently the ability to infuse local anesthetic drugs into the area of the sternal wound has become available. The studies that have been done thus far have shown efficacy in controlling pain but have been too small to show clinically significant patient outcome differences.
We plan to conduct a phase II/III study of local anesthetic infusion into the sternal wound in adult patients undergoing cardiac surgery.
In the Phase II study, 40 patients will be enrolled in a prospective observational open label, dose escalation study of safety and efficacy of local anesthetic infusion into the sternal wound. Outcome measures for efficacy will be visual analog pain (VAP) scores and opioid consumption. Outcome measures for safety will be plasma ropivacaine concentrations and adverse events.
The dose determined in the phase II study will be used in the Phase III study. In this study, 200 patients will be enrolled in a double blind prospective, randomized, double blind; placebo controlled trial of local anesthetic infusion into the sternal wound. Outcome measures for efficacy will be visual analog pain (VAP) scores, opioid consumption, time to extubation, pulmonary function tests, duration of ICU and hospital stay, all cause morbidity and mortality. Outcome measure for safety will be adverse events.
Local anesthetic infusion into the sternal wound will be safe and result in improved pain control and reduced time to extubation, duration of ICU and hospital stay.
This will be the first large randomized controlled clinical trial assessing outcomes with the use of local anesthetic infusion into the sternal wound in patients undergoing open-heart surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00586976
|United States, Minnesota|
|Mayo Clinic College of Medicine|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Gregory A. Nuttall, M.D.||Mayo Clinic College of Medicine|