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

NCT ID: NCT00586976

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2008-06-30

Brief 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.

Detailed Description

Background:

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.

Specific Aim:

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.

Hypothesis:

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.

Significance:

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.

Conditions

Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Ropivicaine infusion into the sternal wound

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

0.3% ropivacaine infusion at 4 ml/hr for 64 hours.

2

Normal saline infusion into the sternal wound

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Normal saline infusion at 4 ml/hour for 64 hours.

Interventions

Ropivacaine

0.3% ropivacaine infusion at 4 ml/hr for 64 hours.

Intervention Type: DRUG

Normal saline

Normal saline infusion at 4 ml/hour for 64 hours.

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Nordic

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic College of Medicine

Principal Investigators

Gregory A. Nuttall, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic College of Medicine

Locations

Mayo Clinic College of Medicine

Rochester, Minnesota, United States

Countries

United States

References

Agarwal S, Nuttall GA, Johnson ME, Hanson AC, Oliver WC Jr. A prospective, randomized, blinded study of continuous ropivacaine infusion in the median sternotomy incision following cardiac surgery. Reg Anesth Pain Med. 2013 Mar-Apr;38(2):145-50. doi: 10.1097/AAP.0b013e318281a348.

Reference Type: DERIVED

PMID: 23386053 (View on PubMed)

Other Identifiers

Contract number 1a5777

Identifier Type: -

Identifier Source: secondary_id

1107-05

Identifier Type: -

Identifier Source: org_study_id