Intrathecal Hydromorphone vs Morphine for Post-Cesarean Pain in Opioid Use Disorder
Trial Summary
What is the purpose of this trial?
This is a single center, double-blind, randomized trial to compare the effects of intrathecal hydromorphone versus intrathecal morphine to treat post cesarean pain in patients with OUD taking buprenorphine. Inclusion criteria include American Society of Anesthesiologists (ASA) Physical Status II or III presenting for cesarean delivery to be done under spinal anesthesia, who have a diagnosis of OUD and are taking buprenorphine. Exclusion criteria include contraindication to spinal anesthesia, allergy/intolerance to acetaminophen or ibuprofen and laboring patients who have an epidural that will be used for anesthesia for cesarean delivery. Potential subjects will be approached about participating in the study at either their preop anesthesia visit or on the day of surgery after surgical and anesthesia consent has been obtained. Enrolled patients will be randomly allocated to receive either 200 mcg of intrathecal morphine or 100 mcg of intrathecal hydromorphone (study opioid medication). Intraoperatively, with the patient in a sitting position a spinal block will be performed with administration of 0.75% bupivacaine in 8.25% dextrose, 15 mcg fentanyl and the study opioid medication. Supplemental intraoperative analgesia/anxiolysis will be administered at the discretion of the anesthesia care team. Ultrasound-guided transversus abdominis plane blocks will be performed bilaterally at the end of the procedure with 10mL liposomal bupivacaine mixed with 10mL 0.25% bupivacaine injected on each side. Post-cesarean multimodal pain regimen will include scheduled acetaminophen 650mg every 6 hours and scheduled ibuprofen 600mg every 6 hours. Oxycodone will be ordered for breakthrough pain, starting at 5mg every 6 hours as needed. Escalation of as needed pain medication will be at the discretion of the anesthesia team. The patient will be followed for the following 36 hours postoperatively. The primary outcome is the patient's pain score with movement at 12 hours. Secondary outcomes include pain scores at rest and with movement at 6 and 24 hours, satisfaction with anesthesia, time to first opioid use, total opioid consumption in 24 and 36 hours, subjective rating of nausea and pruritis over first 24 hours , treatment for nausea or pruritis in 24 and 36 hours, Obstetric Quality of Recovery 10 (ObsQoR10) score, and Global Health Numeric Rating Scale (NRS) score.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications, but it does require participants to be taking buprenorphine.
What data supports the effectiveness of the drug for post-cesarean pain in patients with opioid use disorder?
Research shows that intrathecal hydromorphone can be an effective alternative to morphine for pain relief after cesarean delivery, especially in patients with opioid use disorder. A case report highlighted that continuous epidural hydromorphone infusion significantly reduced opioid consumption and pain scores in a patient with opioid use disorder, suggesting its potential effectiveness in similar cases.12345
Is intrathecal hydromorphone safe for post-cesarean pain management?
How does the drug intrathecal hydromorphone differ from other treatments for post-cesarean pain in patients with opioid use disorder?
Intrathecal hydromorphone is unique because it is administered directly into the spinal fluid, providing targeted pain relief for post-cesarean delivery, especially in patients with opioid use disorder who may have developed tolerance to other opioids. This method can reduce the need for additional oral opioids and improve pain management compared to traditional treatments.12345
Research Team
Amy Penwarden, MD
Principal Investigator
University of North Carolina, Chapel Hill
Eligibility Criteria
This trial is for patients with Opioid Use Disorder (OUD) who are taking buprenorphine and undergoing cesarean delivery under spinal anesthesia. They should be in good or stable condition (ASA Physical Status II or III). Those allergic to acetaminophen, ibuprofen, or with contraindications to spinal anesthesia cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either intrathecal hydromorphone or morphine during cesarean delivery under spinal anesthesia
Immediate Postoperative Monitoring
Participants are monitored for pain scores, satisfaction, and opioid side effects at 6, 12, and 24 hours postoperatively
Follow-up
Participants are monitored for safety and effectiveness after treatment, including pain scores and opioid consumption
Treatment Details
Interventions
- Intrathecal Hydromorphone
- Intrathecal Morphine
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor