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

April 6, 2015 updated by: Mayo Clinic
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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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
Normal saline infusion at 4 ml/hour for 64 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual analog pain
Time Frame: 64 hours
64 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
drug toxicity
Time Frame: 64 hours
64 hours
infection
Time Frame: 64 hours
64 hours
narcotic usage
Time Frame: 64 hours
64 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Gregory A. Nuttall, M.D., Mayo Clinic College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

January 4, 2008

First Posted (Estimate)

January 7, 2008

Study Record Updates

Last Update Posted (Estimate)

April 7, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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