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RECRUITING
NCT06572241
NA

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

Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

View on ClinicalTrials.gov

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.

Official title: Quality of Labour Epidural Analgesia With Intrathecal Morphine as a Component of Combined Spinal Epidural: a Double-blinded Randomized Control Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

182

Start Date

2024-11-20

Completion Date

2026-12

Last Updated

2026-04-01

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Intrathecal morphine

morphine 100 mcg, included in the intrathecal component of combined spinal epidural (CSE).

OTHER

Saline solution (placebo)

normal saline 0.2 ml added to the intrathecal component of combined spinal epidural (CSE).

Locations (1)

Mount Sinai Hospital

Toronto, Ontario, Canada