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Search / Trial NCT06572241

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

Launched by SAMUEL LUNENFELD RESEARCH INSTITUTE, MOUNT SINAI HOSPITAL · Aug 23, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Combined Spinal Epidural Cse Intrathecal Morphine

ClinConnect Summary

This clinical trial is studying a method to help manage pain during labor by testing whether adding a small dose of morphine to a spinal pain relief technique (called combined spinal epidural or CSE) can reduce the amount of breakthrough pain women experience. CSE combines two types of pain relief: a quick-acting spinal injection and a longer-lasting epidural. The goal is to see if the morphine can provide better pain control during labor, making the experience more comfortable for mothers.

To participate in this study, women who are at least 18 years old and having their first baby (at least 37 weeks pregnant) can join if they request pain relief and have not yet reached 6 centimeters of cervical dilation. However, certain conditions might make them ineligible, such as having chronic pain issues, using certain medications recently, or if labor is expected to be very short. Participants in the trial will receive the pain relief treatment and be monitored to see how well it works for them. Overall, this study aims to improve labor pain management for expectant mothers.

Gender

FEMALE

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

About Samuel Lunenfeld Research Institute, Mount Sinai Hospital

The Samuel Lunenfeld Research Institute at Mount Sinai Hospital is a leading biomedical research facility dedicated to advancing our understanding of human health and disease. Renowned for its innovative research programs, the institute focuses on areas such as cancer, genetics, and reproductive health, fostering collaboration among top-tier scientists and clinicians. With a commitment to translating research findings into clinical applications, the Samuel Lunenfeld Research Institute plays a pivotal role in the development of novel therapies and interventions, thereby contributing to improved patient outcomes and the advancement of medical science.

Locations

Toronto, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Naveed Siddiqui, MD

Principal Investigator

MOUNT SINAI HOSPITAL

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported