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

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ClinicalTrials.gov Identifier: NCT00586976
Recruitment Status : Terminated (Stopped by DSMB due to increased wound infection rate.)
First Posted : January 7, 2008
Last Update Posted : April 7, 2015
Sponsor:
Collaborator:
Stryker Nordic
Information provided by:
Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Cardiac Surgery Drug: Ropivacaine Drug: Normal saline Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II/III Study of Continuous Local Anesthetic Infusion in Median Sternotomy Following Cardiac Surgery
Study Start Date : July 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Ropivicaine infusion into the sternal wound
Drug: Ropivacaine
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.



Primary Outcome Measures :
  1. Visual analog pain [ Time Frame: 64 hours ]

Secondary Outcome Measures :
  1. drug toxicity [ Time Frame: 64 hours ]
  2. infection [ Time Frame: 64 hours ]
  3. narcotic usage [ Time Frame: 64 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00586976


Locations
United States, Minnesota
Mayo Clinic College of Medicine
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Stryker Nordic
Investigators
Principal Investigator: Gregory A. Nuttall, M.D. Mayo Clinic College of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gregory A. Nuttall, Mayo Clinic College of Medicine
ClinicalTrials.gov Identifier: NCT00586976     History of Changes
Other Study ID Numbers: 1107-05
Contract number 1a5777
First Posted: January 7, 2008    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by Mayo Clinic:
pain, ropivacaine, infusion, sternotomy

Additional relevant MeSH terms:
Anesthetics
Ropivacaine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents