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

NCT06572241 | Recruiting

• 1 other identifier: 24-06
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain

Keywords

combined spinal epidural; CSE; intrathecal morphine

Outcome Measures

Primary Outcomes (1)

• Presence of breakthrough pain: questionnaire

  The rate of breakthrough pain is defined as the ratio of the number of episodes of breakthrough pain during labour analgesia and the duration of epidural analgesia. An episode of breakthrough pain during labour analgesia was defined as subjective discomfort due to pain or pressure increasing during a contraction (rated as NRS ≥3/10), which was successfully treated with the manual administration of supplemental medications.

  24 hours

Secondary Outcomes (17)

• Time to first episode of breakthrough pain in minutes

  24 hours

• Epidural medication consumption (milliliters)

  24 hours

• Epidural pump settings: questionnaire

  24 hours

• Presence of fetal heart rate anomalies: questionnaire

  24 hours

• Presence of Cesarean delivery: questionnaire

  24 hours

Study Arms (2)

Morphine

ACTIVE COMPARATOR

0.6 ml of 0.25% bupivacaine, fentanyl 10 mcg with morphine 100 mcg (total volume 1 ml) as intrathecal component of combined spinal epidural (CSE).

Drug: Intrathecal morphine

Placebo

PLACEBO COMPARATOR

0.6 ml of 0.25% bupivacaine, fentanyl 10 mcg with normal saline 0.2 ml (total volume 1 ml) as intrathecal component of combined spinal epidural (CSE).

Other: Saline solution (placebo)

Interventions

Intrathecal morphine DRUG

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

Also known as: Morphine

Morphine

Saline solution (placebo) OTHER

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

Also known as: saline

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

RECRUITING

MeSH Terms

Conditions

Labor Pain

Interventions

Morphine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Naveed Siddiqui, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naveed Siddiqui, MD

CONTACT

416-586-5270; naveed.siddiqui@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 27, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)