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

• Status: Terminated
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: Stryker Nordic
• Treatments: Anesthetics; Anesthetics, Local; Ropivacaine

Criteria

Inclusion Criteria:

1. Be greater than 18 years of age

2. 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)

Exclusion Criteria:

1. Are unable to grant informed consent or comply with study procedure

2. Are undergoing emergency open heart-surgery

3. Allergic to any of the excipients in ropivacaine, propofol, and fentanyl

4. Age < 18 years of age (children have dosing and toxicity concerns)

5. Are pregnant (pregnancy changes pain thresholds)

6. Taking preoperative opioids. (Opioid tolerant patients will require significantly more post-operative opioid use.)

7. Cirrhosis or hepatic failure (may have accumulation of local anesthetic in plasma due to decreased metabolism)

8. Patient receiving lidocaine infusion prior to surgery. (An extremely rare event)

9. Patients having a planned circulatory arrest for their surgical procedure (increased duration of intubation possible)