A Phase II/III Study of Continuous Local Anesthetic Infusion in Median Sternotomy Following Cardiac Surgery
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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 |
- Visual analog pain [ Time Frame: 64 hours ] [ Designated as safety issue: No ]
- 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 |
Inclusion Criteria:
- Be greater than 18 years of age
- 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:
- Are unable to grant informed consent or comply with study procedure
- Are undergoing emergency open heart-surgery
- Allergic to any of the excipients in ropivacaine, propofol, and fentanyl
- Age < 18 years of age (children have dosing and toxicity concerns)
- Are pregnant (pregnancy changes pain thresholds)
- Taking preoperative opioids. (Opioid tolerant patients will require significantly more post-operative opioid use.)
- Cirrhosis or hepatic failure (may have accumulation of local anesthetic in plasma due to decreased metabolism)
- Patient receiving lidocaine infusion prior to surgery. (An extremely rare event)
- Patients having a planned circulatory arrest for their surgical procedure (increased duration of intubation possible)
Contacts and Locations| United States, Minnesota | |
| Mayo Clinic College of Medicine | |
| Rochester, Minnesota, United States, 55905 | |
| 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, Local Ropivacaine Anesthetics Central Nervous System Depressants Physiological Effects of Drugs |
Pharmacologic Actions Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013