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

This study has suspended participant recruitment.
(Stopped by DSMB due to increased wound infection rate.)
Sponsor:
Collaborator:
Stryker Nordic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00586976
First received: December 21, 2007
Last updated: November 9, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Cardiac Surgery
Drug: Ropivacaine
Drug: Normal saline
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II/III Study of Continuous Local Anesthetic Infusion in Median Sternotomy Following Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Visual analog pain [ Time Frame: 64 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • drug toxicity [ Time Frame: 64 hours ] [ Designated as safety issue: Yes ]
  • infection [ Time Frame: 64 hours ] [ Designated as safety issue: Yes ]
  • narcotic usage [ Time Frame: 64 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: July 2005
Estimated Study Completion Date: June 2008
Estimated Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Mayo Clinic

Additional 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
Study First Received: December 21, 2007
Last Updated: November 9, 2009
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 24, 2014