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

RecruitingNAAges 18 Years - 50 YearsFemaleSamuel Lunenfeld Research Institute, Mount Sinai …
NCT06572241 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 op

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adult (≥18 years) term primiparous (≥37 weeks) patients with live singleton pregnancy * Patients who request labour analgesia and do not have any contraindications for neuraxial analgesia. * Less than or equal to 6 cm cervical dilation during the last vaginal examination. Exclusion Criteria: * Patients who are expected to be discharged within 24 hours of delivery. * Patients with chronic pain conditions, opioid use disorder, pre-gestational diabetes, obstructive sleep apnea, morbid obesity (BMI \>40 kg/m2), or fetal abnormalities. * Patients who have intramuscular morphine within 12 hours or fentanyl \>200 mcg in the preceding 4 hours. * Participants will be excluded from further analysis in case of spinal analgesic failure * Participants will be excluded from further analysis if labour lasts less than 2 hours
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What it tests

  • Intrathecal morphine
  • Saline solution (placebo)
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Where

1 site
Mount Sinai Hospital
Toronto, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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