Improving labor pain relief with intrathecal morphine in combined spinal epidural
Quality of Labour Epidural Analgesia With Intrathecal Morphine as a Component of Combined Spinal Epidural: a Double-blinded Randomized Control Trial
This study is testing if adding intrathecal morphine to the usual pain relief method during labor can help first-time moms feel less pain for longer and need fewer extra medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 182 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06572241 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of adding intrathecal morphine to combined spinal epidural (CSE) analgesia for labor pain relief in primigravidae patients. The study aims to determine if this combination can prolong pain relief and reduce the need for additional analgesics during labor. By focusing on a specific patient population, the trial seeks to provide more definitive evidence on the benefits and potential risks of using intrathecal morphine in this context. The methodology includes a randomized controlled trial design to ensure robust results.
Who should consider this trial
Good fit: Ideal candidates for this study are adult primiparous patients requesting labor analgesia who are less than or equal to 6 cm cervical dilation.
Not a fit: Patients with chronic pain conditions, opioid use disorder, or those expected to be discharged within 24 hours of delivery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance pain management during labor, leading to improved maternal satisfaction and reduced workload for healthcare providers.
How similar studies have performed: Previous studies have shown promising results with similar approaches, but this trial aims to provide more conclusive evidence with a larger and more specific patient population.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Naveed Siddiqui, MD — Mount Sinai Hospital
- Study coordinator: Naveed Siddiqui, MD
- Email: naveed.siddiqui@uhn.ca
- Phone: 416-586-5270
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.