Comparing intrathecal hydromorphone and morphine for pain relief after cesarean delivery in patients with opioid use disorder
Intrathecal Hydromorphone vs Intrathecal Morphine to Treat Post Cesarean Pain in Patients With Opioid Use Disorder Taking Buprenorphine
This study is testing whether a new pain relief method using hydromorphone works better than morphine for women with opioid use disorder after having a cesarean delivery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06784180 on ClinicalTrials.gov |
What this trial studies
This clinical trial is designed to compare the effectiveness of intrathecal hydromorphone versus intrathecal morphine for managing post-cesarean pain in patients diagnosed with opioid use disorder (OUD) who are currently taking buprenorphine. It is a single-center, double-blind, randomized trial where eligible participants will receive either 200 mcg of intrathecal morphine or 100 mcg of intrathecal hydromorphone during their cesarean delivery under spinal anesthesia. The study aims to address the challenges of pain management in this specific patient population, which has seen a significant increase in OUD cases during pregnancy. Participants will be approached for enrollment during their preoperative visit or on the day of surgery after obtaining necessary consents.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women with opioid use disorder who are taking buprenorphine and are scheduled for a cesarean delivery under spinal anesthesia.
Not a fit: Patients who have contraindications to spinal anesthesia or those who are laboring with an epidural in place for anesthesia will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective pain management option for postpartum patients with opioid use disorder, potentially improving recovery outcomes.
How similar studies have performed: Other studies have explored pain management in patients with opioid use disorder, but this specific comparison of intrathecal hydromorphone and morphine in this population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * American Society of Anesthesiologists (ASA) Physical Status II or III presenting for cesarean delivery to be done under spinal anesthesia, * have a diagnosis of OUD * taking buprenorphine Exclusion Criteria: * Contraindication to spinal anesthesia, * allergy/intolerance to acetaminophen or ibuprofen * laboring patients who have an epidural that will be used for anesthesia for cesarean delivery
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Amy Penwarden, MD — University of North Carolina, Chapel Hill
- Study coordinator: Amy Penwarden, MD
- Email: amy_penwarden@med.unc.edu
- Phone: 919-966-5136
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.