Spinal Hydromorphone Versus Morphine for Post-Cesarean Delivery Analgesia: A Non-Inferiority Trial
Description:
Spinal or intrathecal (IT) morphine is the most commonly used opioid for post-cesarean
delivery analgesia. Factors that contribute to its widespread use include a favorable
pharmacokinetic profile with duration of action up to 24 hours, ease of administration
(during spinal block for surgical anesthesia) and low cost. Most providers administer 100 to
200 mcg of IT morphine for cesarean delivery analgesia with excellent analgesic results.
Nevertheless, subarachnoid use of morphine is not without adverse events. While
dose-dependent respiratory depression is the most worrisome complication, other side effects
such as pruritus, nausea, vomiting and urinary retention can be bothersome during early
puerperium. Furthermore, shortages of preservative free morphine in the United States has led
clinicians to seek a reasonable alternative.
For the last 20 years, spinal hydromorphone has been successfully used for chronic pain
associated with neoplasms. Its use for post-cesarean analgesia has been successfully
reported. However, data regarding its efficacy in the IT space for post-cesarean analgesia is
scarce. In the past, doses of 40 to 100 mcg have been reported to provide adequate
postoperative pain relief with minimal side effects. In a recent study, the Effective Dose in
90% of patients has been established for both Hydromorphone and Morphine to be 75 mcg and 150
mcg, respectively.
No prospective studies have been conducted to specifically establish non-inferiority of
hydromorphone when compared to morphine for post- cesarean analgesia. In addition, while all
opioids share the same side effect profile, the frequency of those events are unknown for IT
hydromorphone.
The current proposal is a blinded randomized controlled trial of intrathecal hydromorphone
versus morphine in term pregnant women undergoing elective cesarean deliveries under spinal
anesthesia.
Condition:
Postoperative Pain
Treatment:
Spinal Hydromorphone
Start Date:
January 2020
Sponsor:
Lawson Health Research Institute
For More Information:
https://clinicaltrials.gov/show/NCT03592992