Use of On-Q Pump for Pain Post C-Section
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/6/2019 |
| Start Date: | July 2015 |
| End Date: | December 2019 |
Multimodal Post-Cesarean Analgesia With Spinal Morphine and Continuous Wound Infiltration of Ropivacaine Using the OnQ® Elastomeric Pump: A Dose-Ranging Study Using a High-Volume, Low-Dose Protocol
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.
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.
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.
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.
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
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Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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