Clinical trial NCT02579629: Use of On-Q Pump for Pain Post C-Section
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Analgesia
Cesarean section
Opiates
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in Pain Scores During Cough From Baseline
timeFrame: 2 hours post baseline, 6, 12, 24, 48, 72 hours post baseline
measure: Change in Pain Scores During 20°Straight Leg Raise
timeFrame: Baseline (At zero time, the time of the first dosing using the On-Q catheter), 2, 6, 12, 24, 48, 72 hours post baseline
measure: Change in Intensity of Pain: Numerical Pain Scale (NPS) From Baseline
timeFrame: 6 weeks, 3 months
measure: Change in Intensity of Pain: VAPS From Baseline
timeFrame: 24 hours post-intervention, 48 hrs, and 72hr post-intervention.
measure: Change in McGill Pain Questionnaire Score From Baseline
timeFrame: 2 hours post-intervention, 6 hours, 12 hours, 24 hours, 72 hours, 6 weeks, 3 months post-intervention
measure: Change in Pain Scores at Rest From Baseline
timeFrame: 2 hours post-intervention, 6 hours, 12 hours, 24 hours, 48 hous, 72 hours post baseline
Secondary outcomes:
measure: Change in Time From Baseline to First Dose of Rescue Medications
timeFrame: Baseline (At zero time, the time of the first dosing using the On-Q catheter), 72 hours post-operatively
measure: Breastfeeding Success
timeFrame: In the post-anesthesia care unit (up to 2 hours post-operatively), 72 hours post-operatively
measure: Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention
timeFrame: 24 hours, 48 hours, 72 hours post intervention
measure: Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention
timeFrame: 6 weeks postintervention, 3 months postintervention
measure: Cost Analysis
timeFrame: At the time of hospital discharge (average of 3 days)
measure: Patient Satisfaction at 72 Hours Post Intervention
timeFrame: 72 hours post-operatively
measure: Dosing Amount of Non-steroidal Anti-inflammatory Drugs
timeFrame: 24 post-operatively, 72 hours post-operatively
measure: Amount of Opioid Use
timeFrame: 24 post-operatively, 72 hours post-operatively
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
Study officials:
affiliation: Emory University
name: James Dolak, MD
role: PRINCIPAL_INVESTIGATOR
References: