Actively Recruiting
Quality of Labour Epidural Analgesia With Intrathecal Morphine as a Component of Combined Spinal Epidural
Led by Samuel Lunenfeld Research Institute, Mount Sinai Hospital · Updated on 2026-04-01
182
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Quality of Labour Epidural Analgesia With Intrathecal Morphine as a Component of Combined Spinal Epidural
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Cervical dilation less than or equal to 6 cm during the last vaginal examination
You will not qualify if you...
- Patients 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 received intramuscular morphine within 12 hours or fentanyl >200 mcg in the preceding 4 hours
- Participants with spinal analgesic failure
- Participants if labour lasts less than 2 hours
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Actively Recruiting
Research Team
N
Naveed Siddiqui, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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