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Atlanta, Georgia 30308


Purpose:

The main purpose of this study is to examine if pain levels treated with intrathecal (IT) preservative-free morphine (PFM) after a cesarean section improve with the additional use of continuous subfascial wound infiltration with ropivacaine using the OnQ® elastomeric pump system.


Study summary:

The main purpose of this study is to examine if pain levels treated with intrathecal (IT) preservative-free morphine (PFM) after a cesarean section improve with the additional use of continuous subfascial wound infiltration with ropivacaine using the OnQ® elastomeric pump system. As a double-blinded, randomized, placebo controlled study, women undergoing first, second or third cesarean section will be randomly assigned to one of 3 different groups. Group 1 will receive saline, group 2 will be given ropivacaine 0.1%, group 3 will be given ropivacaine 0.2%, all at a rate of 8ml/hr via the OnQ® pump system. Each group will also receive an 8mL bolus of the previously assigned infusate. The investigator will assess pain at rest and with movement at different time periods during the recovery process through 3 months post operatively. The investigator will also assess if the use of this system decreases the need for other pain medications and reduces the potential side-effects of pain treatment.


Criteria:

Inclusion Criteria: 1. Female patients at Emory University Hospital Midtown undergoing non-emergent, scheduled or unscheduled first, second or third Cesarean sections 2. Patients who are American Society of Anesthesiology (ASA) Class I-III 3. Patients are at least 34 weeks pregnant 4. Patients to receive spinal anesthesia for their procedure 5. Patients who are 18 years of age or older 6. Patient willing and able to provide written informed consent Exclusion Criteria: 1. Patients with 3 or more prior Cesarean sections 2. Patients undergoing emergent cesarean section with or without general anesthesia 3. Patients with known allergy to morphine, ketorolac, and/or amide local anesthetics 4. Patients who will not receive spinal anesthesia 5. Patients who are less than 34 weeks pregnant 6. Patients with significant maternal cardiac, liver or renal disease 7. Patients with maternal history of narcotic abuse or dependency 8. Patient with pre-operative fever (>100.4 degrees F) 9. Patients less than 18 years old


NCT ID:

NCT02579629


Primary Contact:

Principal Investigator
James Dolak, MD
Emory University


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30308
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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