RecruitingNot ApplicableNCT06572241

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

Quality of Labour Epidural Analgesia With Intrathecal Morphine as a Component of Combined Spinal Epidural: a Double-blinded Randomized Control Trial


Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Enrollment

182 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether adding a small dose of morphine to the spinal component of a combined spinal-epidural (CSE) technique can improve pain relief during labor. It is comparing the quality and duration of pain relief between different methods. **You may be eligible if...** - You are 18 or older and pregnant (at least 37 weeks) - This is your first birth (primiparous) - You are carrying a single baby - Your cervix is dilated 6 cm or less - You are requesting pain relief during labor and have no reason you cannot have an epidural **You may NOT be eligible if...** - You have chronic pain, opioid use disorder, diabetes (pre-existing), obstructive sleep apnea, or morbid obesity (BMI over 40) - You have a fetal abnormality - You have recently received morphine or high-dose fentanyl - You are expected to be discharged within 24 hours of delivery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIntrathecal morphine

morphine 100 mcg, included in the intrathecal component of combined spinal epidural (CSE).

OTHERSaline solution (placebo)

normal saline 0.2 ml added to the intrathecal component of combined spinal epidural (CSE).


Locations(1)

Mount Sinai Hospital

Toronto, Ontario, Canada

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NCT06572241


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