Intrathecal Hydromorphone for Pain Control After Cesarean Section
- Conditions
- Cesarean SectionPain
- Interventions
- Registration Number
- NCT02096003
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 80
- Elective primary cesarean section
- Females age 18-40
- Emergency cesarean section
- Anesthetic other than spinal
- History of chronic pain or pre-op opioid use
- Allergy to morphine or hydromorphone
- BMI>40
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intrathecal hydromorphone Intrathecal hydromorphone 50mcg intrathecal hydromorphone added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections. Intrathecal morphine Intrathecal morphine 0.25mg ( 250mcg) intrathecal morphine added to 1.5 mg 0.75% bupivicaine for single shot spinal anesthesia in primary cesarean sections
- Primary Outcome Measures
Name Time Method Post Operative Fentanyl PCA Consumption at 24 hours Total dose of fentanyl patient controlled analgesia (pca) used in 24 hours post-op.
- Secondary Outcome Measures
Name Time Method Patient Satisfaction Score at 24 hours Patient satisfaction score - total scale of 1-5, with higher score indicating more satisfaction
Symptom Scale for Two Specific Side Effects of Nausea and Pruritus up to 24 hours Symptom scale for nausea and pruritus. Full scale from 1-5, with higher score indicating more symptoms.
Time to Initial PCA Use up to 24 hours When does the patient need to use the PCA for the first time? This will be used to assess when morphine and hydromorphone first begin to provide analgesia.
Pain Score at 24 hours Assess pain scores on a scale of 1-5, with higher score indicating more pain.
Trial Locations
- Locations (1)
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States