Use of On-Q Pump for Pain Post C-Section

Emory University

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Ropivacaine 0.2%; Drug: Normal saline; Drug: Ropivacaine 0.1%; Device: On-Q ® elastomeric pump

Study type: Interventional

Funder types: Other

Identifiers

NCT02579629

IRB00073292

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 64 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 3 patient groups

Ropivacaine 0.1%

Active Comparator group

Description:

Subjects undergoing their first,second or third cesarean sections will receive a bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.

Treatment:

Device: On-Q ® elastomeric pump

Drug: Ropivacaine 0.1%

Ropivacaine 0.2%

Experimental group

Description:

Subjects undergoing their first,second or third cesarean sections will receive a bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump for 3 days after the cesarean section.

Treatment:

Device: On-Q ® elastomeric pump

Drug: Ropivacaine 0.2%

Normal Saline

Active Comparator group

Description:

Subjects undergoing their first, second or third cesarean sections will receive a bolus dose of 8ml normal saline followed by an infusion of 8ml/hr of normal saline using the On-Q® elastomeric pump for 3 days after the cesarean section.

Treatment:

Device: On-Q ® elastomeric pump

Drug: Normal saline