Phase 2
N=80
Intrathecal Hydromorphone for Pain Control After Cesarean Section
Pain · Cesarean Section
Bottom Line
View on ClinicalTrials.gov: NCT02096003 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Post Operative Fentanyl PCA Consumption — 300; 446 µg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Intrathecal morphine (Drug); Intrathecal hydromorphone (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Operative Fentanyl PCA Consumption |
300; 446 | — |
| SECONDARY Time to Initial PCA Use |
— | — |
| SECONDARY Pain Score |
4.8; 4.7 | — |
| SECONDARY Patient Satisfaction Score |
4.8; 4.6 | — |
| SECONDARY Symptom Scale for Two Specific Side Effects of Nausea and Pruritus |
4.4; 4.7; 3.8; 4 | — |
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.
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
- BMI>40
Data sourced from ClinicalTrials.gov (NCT02096003). 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.