Clinical Trial

Quality of Labour Epidural Analgesia With Intrathecal Morphine as a Component of Combined Spinal Epidural

Recruiting
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Summary
Neuraxial analgesia has shown to be the gold standard for effective labor pain relief, offering numerous benefits including enhanced pain control and maternal satisfaction. The methods to achieve neuraxial analgesia include lumbar epidural (LE), and combined spinal epidural (CSE). While LE may not consistently provide optimal pain relief, leading to frequent maternal requests for supplemental analgesics, CSE presents a promising advancement. This is due to the rapid onset of pain relief from intrathecal components, complemented by the longer-lasting effects of epidural medications. Intrathecal drugs have demonstrated the ability to offer more symmetrical blockades compared to epidurally administered medications. Nonetheless, some clinicians remain cautious about CSE due to the potential for increased pain when transitioning from spinal to less effective epidural analgesia. Long-acting opioids like morphine in the intrathecal space may mitigate this problem by providing transitional analgesia to the laboring parturient. The primary aim of this randomized controlled trial is to provide evidence of whether the addition of 100 mcg of morphine in the intrathecal (spinal) component of CSE reduces the rate of breakthrough pain during labor.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-08-23; most recent amendment 2026-03-31.
Status change: Not Yet Recruiting → Recruiting 2024-09-06
Trial Details
NCT Number NCT06572241
Lead Sponsor Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Conditions Labor Pain
Enrollment 182 participants
Start Date 2024-11-20
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-01