Comparison of Intrathecal Hydromorphone and Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery
Overview
- Phase
- Phase 2
- Intervention
- Intrathecal morphine
- Conditions
- Pain
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Post Operative Fentanyl PCA Consumption
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The use of intrathecal opioids for analgesia in the setting of cesarean section has become standard obstetric anesthesia practice. Currently, two opioids are commonly used. These opioids are fentanyl and morphine (Duramorph). Intrathecal opioids are an excellent source of analgesia and act to reduce the stress response to surgery.
Currently, most obstetric anesthesiologists use intrathecal morphine for analgesia after cesarean delivery. Morphine provides excellent analgesia for cesarean section. However, use of this medication is associated with side effects such as pruritus and nausea and vomiting.
Recently, multiple obstetric anesthesia groups began to use intrathecal hydromorphone for cesarean delivery when morphine was unavailable. As groups began to use hydromorphone, retrospective data became available that demonstrated its safety and efficacy for use during cesarean section.
In order to fully elucidate the analgesic and side effect properties of hydromorphone for cesarean delivery, a prospective randomized, double blind study comparing morphine and hydromorphone is necessary. The investigators need to understand whether hydromorphone is as effective as morphine for analgesia after cesarean section, and whether it is associated with fewer or more side effects. The results of the study will allow providers to make educated decisions to better care for their patient.
Investigators
Yaakov Beilin
Professor of Anesthesiology
Icahn School of Medicine at Mount Sinai
Eligibility Criteria
Inclusion Criteria
- •Elective primary cesarean section
- •Females age 18-40
Exclusion Criteria
- •Emergency cesarean section
- •Anesthetic other than spinal
- •History of chronic pain or pre-op opioid use
- •Allergy to morphine or hydromorphone
Arms & Interventions
Intrathecal morphine
0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections
Intervention: Intrathecal morphine
Intrathecal hydromorphone
50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections.
Intervention: Intrathecal hydromorphone
Outcomes
Primary Outcomes
Post Operative Fentanyl PCA Consumption
Time Frame: at 24 hours
Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op.
Secondary Outcomes
- Patient Satisfaction Score(at 24 hours)
- Symptom Scale for Two Specific Side Effects of Nausea and Pruritus(up to 24 hours)
- Time to Initial PCA Use(up to 24 hours)
- Pain Score(at 24 hours)