Managing pain after cesarean deliveries
Double Blind Randomized Trial of Post-operative Cesarean Continuous Infusion of Bupivacaine Versus Placebo for Local Incisional Pain Control
NA · University of Colorado, Denver · NCT05131178
This study is testing if a special pain relief device can help women feel less pain and use fewer opioids after having a cesarean delivery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Colorado, Denver (other) |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05131178 on ClinicalTrials.gov |
What this trial studies
This study investigates pain management strategies following cesarean deliveries by comparing the effectiveness of an FDA-approved device, the ON-Q Pump, which delivers local anesthetic bupivacaine, against a saline placebo. The research is conducted at the Colorado Fetal Care Center, which adheres to Enhanced Recovery After Cesarean (ERAC) guidelines to optimize postoperative care. The primary goal is to assess whether the use of the ON-Q Pump contributes to reduced opioid consumption in patients recovering from C-sections.
Who should consider this trial
Good fit: Ideal candidates include pregnant patients aged 18 and older who are undergoing scheduled or unscheduled cesarean deliveries.
Not a fit: Patients with active substance abuse issues or those currently receiving treatment for chronic pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management techniques that minimize opioid use after cesarean deliveries.
How similar studies have performed: Previous studies have shown promising results in reducing opioid use through similar pain management approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant patients 18 years of age or older * Patients undergoing both scheduled and unscheduled cesarean deliveries at CFCC Exclusion Criteria: * Active substance abuse (ex methamphetamines) determined by patient report, toxin screen, or screening physician's determination * Current treatment for chronic pain involving opiate receptor agonism or antagonism (i.e. suboxone, methadone, naltrexone, oxycodone) * Contraindication to neuraxial anesthesia * Known allergies to common anesthetic medications * Inability to consent to study procedures * Patient receiving general anesthesia
Where this trial is running
Aurora, Colorado
- Children's Hospital Colorado — Aurora, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Michael Zaretsky, MD — Children's Hospital Colorado - Colorado Fetal Care Center
- Study coordinator: Clinical Research Manager
- Email: Kaylene.Ross@childrenscolorado.org
- Phone: 720-777-7080
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post-operative Pain, Cesarean Section