Phase 4
N=64
Use of On-Q Pump for Pain Post C-Section
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02579629 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Change in Pain Scores During Cough From Baseline — 4; 1; 20.5; 10 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ropivacaine 0.1% (Drug); Ropivacaine 0.2% (Drug); Normal saline (Drug); On-Q ® elastomeric pump (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Emory University
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Scores During Cough From Baseline |
4; 1; 20.5; 10; 3; 10.5 | — |
| PRIMARY Change in Pain Scores During 20°Straight Leg Raise |
4; 5; 10.5; 8; 0; 5 | — |
| PRIMARY Change in Intensity of Pain: Numerical Pain Scale (NPS) From Baseline |
3; 2; 5; 0; 0; 0 | — |
| PRIMARY Change in Intensity of Pain: VAPS From Baseline |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Change in McGill Pain Questionnaire Score From Baseline |
1.5; 2; 2; 2; 2; 2 | — |
| PRIMARY Change in Pain Scores at Rest From Baseline |
5; 0; 7; 3; 0; 5.5 | — |
| SECONDARY Change in Time From Baseline to First Dose of Rescue Medications |
9.05; 3.50; 2 | — |
| SECONDARY Breastfeeding Success |
10; 6.5; 6.5; 10; 10; 10 | — |
| SECONDARY Number of Participants With Catheter or Infiltrate-related Issues at 24, 48 and 72 Hours Post-intervention |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Patients With Wound Dysesthesia, Infection, Dehiscence and Keloid Formation at 6 Weeks and 3 Months Post-intervention |
2; 2; 6; 0; 0; 0 | — |
| SECONDARY Cost Analysis |
27.9; 26.8; 31.6 | — |
| SECONDARY Patient Satisfaction at 72 Hours Post Intervention |
60; 61.53; 48.3 | — |
| SECONDARY Dosing Amount of Non-steroidal Anti-inflammatory Drugs |
80; 211; 379; 2040; 1726; 1095 | — |
| SECONDARY Amount of Opioid Use |
0.35; 6.45; 1.65; 24.98; 54.28; 31.25 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Female patients at Emory University Hospital Midtown undergoing non-emergent, scheduled or unscheduled first, second or third Cesarean sections
- Patients who are American Society of Anesthesiology (ASA) Class I-III
- Patients are at least 34 weeks pregnant
- Patients to receive spinal anesthesia for their procedure
- Patients who are 18 years of age or older
- Patient willing and able to provide written informed consent
Exclusion Criteria
- Patients with 3 or more prior Cesarean sections
- Patients undergoing emergent cesarean section with or without general anesthesia
- Patients with known allergy to morphine, ketorolac, and/or amide local anesthetics
- Patients who will not receive spinal anesthesia
- Patients who are less than 34 weeks pregnant
- Patients with significant maternal cardiac, liver or renal disease
- Patients with maternal history of narcotic abuse or dependency
- Patient with pre-operative fever (>100.4 degrees F)
- Patients less than 18 years old
Data sourced from ClinicalTrials.gov (NCT02579629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.