Improving labor pain relief with intrathecal morphine in combined spinal epidural

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.