N/A
N=134
Spinal Morphine vs. Hydromorphone for Pain Control After Cesarean Delivery
Analgesia, Obstetrical · Obstetric Surgical Procedures
Bottom Line
View on ClinicalTrials.gov: NCT02789410 ↗Enrolled (actual)
134
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcome: Primary: NRS Score for Pain (0-10) With Movement 24 Hours After Spinal Administration — 4; 3 score on a scale — p=0.132
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Morphine (Drug); Hydromorphone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Mayo Clinic
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NRS Score for Pain (0-10) With Movement 24 Hours After Spinal Administration |
4; 3 | 0.132 |
| SECONDARY Nausea |
28; 32 | 0.590 |
| SECONDARY Pruritus |
27; 28 | 0.971 |
Summary
Intrathecal (IT) opioids are commonly administered with local anesthetic during spinal anesthesia for post-Cesarean delivery analgesia. Traditionally, IT morphine has been used but the use of IT hydromorphone is growing. A previous study has shown that the effective dose for postoperative analgesia in 90% patients (ED90) for both IT hydromorphone and IT morphine (NCT02009722). These doses were found to be 75 mcg for hydromorphone and 150 mcg for morphine. The current proposed study would compare the duration of analgesia of IT morphine vs IT hydromorphone after elective cesarean delivery. Additionally, the investigators will compare each drug with respect the incidence of nausea and pruritus.
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiologists (ASA) physical status II-III women presenting for elective cesarean delivery
- Term gestation (37-42 weeks)
- Desire to have a spinal anesthesia technique for cesarean delivery
Exclusion Criteria
- Any contraindication to the administration of a spinal technique for anesthesia
- History of intolerance or adverse reaction to opioid medications
- Chronic pain syndrome or current opioid use >30 oral morphine equivalents/day
- Allergy or intolerance to acetaminophen, ketorolac, ibuprofen, or oxycodone
- Current BMI > 50
Data sourced from ClinicalTrials.gov (NCT02789410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.