Phase 4
N=84
Impact of Local Anesthetic Wound Infiltration on Postoperative Pain Following Cesarean Delivery
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02829944 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Pain Score on Movement (Sitting in Bed From a Supine Position) — 5; 5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ropivacaine (Drug); Ketorolac (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score on Movement (Sitting in Bed From a Supine Position) |
5; 5 | — |
| SECONDARY Pain Scores at Rest |
2; 2 | — |
| SECONDARY Pain Scores at Rest |
2; 2 | — |
| SECONDARY Pain Scores at Rest |
2; 2 | — |
| SECONDARY Opioid Consumption |
20; 10 | — |
| SECONDARY Opioid Consumption |
20; 10 | — |
| SECONDARY Opioid Consumption |
20; 10 | — |
| SECONDARY Time to First Rescue Analgesic |
660; 954 | — |
| SECONDARY Number of Subjects Experiencing Nausea |
4; 1 | — |
| SECONDARY Number of Subjects Experiencing Nausea |
4; 1 | — |
| SECONDARY Number of Subjects Experiencing Nausea |
4; 1 | — |
| SECONDARY Number of Subjects Experiencing Vomiting |
1; 0 | — |
| SECONDARY Number of Subjects Experiencing Vomiting |
1; 0 | — |
| SECONDARY Number of Subjects Experiencing Vomiting |
1; 0 | — |
| SECONDARY Number of Subjects Experiencing Pruritus |
0; 0 | — |
| SECONDARY Number of Subjects Experiencing Pruritus |
0; 0 | — |
| SECONDARY Number of Subjects Experiencing Pruritus |
0; 0 | — |
| SECONDARY Patient Satisfaction With Postoperative Analgesia on a 0-10 Scale |
9.5; 8 | — |
| SECONDARY Number of Subjects With Chronic Pain |
0; 0 | — |
| SECONDARY Number of Subjects With Chronic Pain |
0; 0 | — |
| SECONDARY Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale |
3; 1 | — |
| SECONDARY Postpartum Depression, as Measured by the Edinburgh Postnatal Depression Scale |
3; 1 | — |
| SECONDARY Pain Score on Movement |
5.5; 5 | — |
Summary
The purpose of this study is to determine if the infusion of the local anesthetic ropivacaine (a numbing medicine) and the non-steroidal anti-inflammatory drug ketorolac (a pain killer similar to ibuprofen) through a catheter placed along the cesarean delivery incision, will reduce the pain experienced after cesarean section and need for narcotic pain medicine.
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiology (ASA) class 1,2, and 3
- English speaking women at a gestational age > 37 weeks
- scheduled for cesarean delivery under spinal or combined spinal epidural anesthesia
Exclusion Criteria
- BMI > 50 kg/m2
- history of intravenous drug or opioid abuse
- previous history of chronic pain syndrome
- history of opioid use in the past week
- allergy or contraindication to any of the study medications
- non-English speaking
Data sourced from ClinicalTrials.gov (NCT02829944). 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.