Cesarean Section Clinical Trial
Official title:
Intrathecal Opioids for Pain Control After Cesarean Delivery: Determining the Optimal Dose
Both hydromorphone and morphine are administered as part of spinal anesthesia to help improve pain control after cesarean delivery. In this study, the investigators are going to determine the doses of each of those medicines that provides optimal pain control to women undergoing cesarean delivery while limiting side effects related to those medicines. The investigators hypothesize that the doses of hydromorphone and morphine that provide optimal pain control without significant side effects will be 100 micrograms and 150 micrograms, respectively. The investigators further hypothesize that at each respective optimal dose, side effects will be less in the hydromorphone group.
Spinal anesthesia is the most common anesthetic technique used for Cesarean delivery in the
United States and across the world. Intrathecal opioids are administered along with a local
anesthetic during spinal anesthesia for Cesarean delivery to provide postoperative
analgesia. The effectiveness of intrathecal morphine for post-Cesarean pain control is well
established, but the effectiveness of intrathecal hydromorphone in this patient population
is limited to case reports and small retrospective studies. No prospective studies have been
conducted to establish the effectiveness of intrathecal hydromorphone for post-Cesarean
pain.
Hydromorphone has been studied extensively as a substitute for intrathecal morphine in
patients with chronic noncancer pain. In fact, a recent consensus article placed
hydromorphone as a first line therapy along with morphine for intrathecal pain management.
Its ability to treat post-Cesarean pain when administered in the epidural space has been
known for quite some time, but its effects in the intrathecal space are less established. In
patients undergoing Cesarean delivery, intrathecal doses of 40 to 100 micrograms have been
reported to provide good pain scores postoperatively with only minimal side effects. Doses
of up to 300 micrograms have been used, leading to excellent pain control without out
respiratory depression, but with significant pruritus and nausea.
Although reducing pain, intrathecal opioids are associated with side effects including
pruritus, nausea, and respiratory depression. A meta-analysis reviewing twenty-eight studies
which investigated intrathecal morphine versus placebo demonstrated moderate increases in
the incidences of pruritus, nausea and vomiting. In fact the incidence of nausea with IT
morphine has been reported to be 33%. While hydromorphone is similar chemically to morphine,
it is metabolized differently. Differences in pharmacokinetics may allow for differences in
side effect profiles. Hydromorphone is more lipid soluble than morphine. This decreases its
spread within the intrathecal space and enhances its penetration into the dorsal horn of the
spinal cord where interactions with opioid receptors occur. Some studies have found that
hydromorphone causes less nausea and pruritus than morphine, while others have not. Although
opioid-induced respiratory depression is a rare event, studies evaluating intrathecal
hydromorphone for post-Cesarean delivery pain have not reported any cases of respiratory
depression.
The optimal dose of intrathecal morphine for analgesia following Cesarean delivery is still
debated and the efficacy of intrathecal hydromorphone has not been studied extensively in
this patient population. The investigators aim to identify the dose of each medication that
provides good pain relief without causing significant side effects. The investigators will
then perform a comparative analysis of each drug at their optimal dose.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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