NCT06572241 Quality of Labour Epidural Analgesia With Intrathecal Morphine as a Component of Combined Spinal Epidural
| NCT ID | NCT06572241 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
| Condition | Labor Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 182 participants |
| Start Date | 2024-11-20 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 182 participants in total. It began in 2024-11-20 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Naveed Siddiqui, MD
PRINCIPAL INVESTIGATOR
MOUNT SINAI HOSPITAL
Frequently Asked Questions
Who can join the NCT06572241 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 50 Years, studying Labor Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06572241 currently recruiting?
Yes, NCT06572241 is actively recruiting participants. Contact the research team at naveed.siddiqui@uhn.ca for enrollment information.
Where is the NCT06572241 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06572241 clinical trial?
NCT06572241 is sponsored by Samuel Lunenfeld Research Institute, Mount Sinai Hospital. The principal investigator is Naveed Siddiqui, MD at MOUNT SINAI HOSPITAL. The trial plans to enroll 182 participants.