A Phase II/III Study of Continuous Local Anesthetic Infusion in Median Sternotomy Following Cardiac Surgery

Stopped early · Phase 2/Phase 3

Conditions studied: Cardiac Surgery

In brief

Cardiac surgery is associated with pain in the post-operative period. We plan to conduct a study of local anesthetic, ropivacaine, infusion into the sternal wound in adult patients undergoing cardiac surgery to see if it will be safe and result in improved pain control and reduced time to extubation, duration of ICU and hospital stay.

Key facts

Study ID: NCT00586976
Run by: Mayo Clinic
People needed: 125
Starts: 2005-07-01
Expected to finish: 2008-06-01
Last updated by the study team: 2015-04-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Be greater than 18 years of age
Be undergoing a cardiac surgical procedure via median sternotomy (i.e., exclude the occasional thoracotomy, since much greater pain with that surgical approach post-operatively)

You may not qualify if…

Are unable to grant informed consent or comply with study procedure
Are undergoing emergency open heart-surgery
Allergic to any of the excipients in ropivacaine, propofol, and fentanyl
Age < 18 years of age (children have dosing and toxicity concerns)
Are pregnant (pregnancy changes pain thresholds)
Taking preoperative opioids. (Opioid tolerant patients will require significantly more post-operative opioid use.)
Cirrhosis or hepatic failure (may have accumulation of local anesthetic in plasma due to decreased metabolism)
Patient receiving lidocaine infusion prior to surgery. (An extremely rare event)
Patients having a planned circulatory arrest for their surgical procedure (increased duration of intubation possible)

Where it is running

Mayo Clinic College of Medicine — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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