Recruiting

Intrathecal Morphine

Sponsor:

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Code:

NCT06572241

Conditions

Labor Pain

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Intrathecal morphine

Saline solution (placebo)

Study Details

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

Study ID

NCT06572241

Start date

Nov 20, 2024

Status verified date

Feb, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

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

Study Design

Enrollment

182 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Morphine

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).

placebo comparator: Placebo

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).

Interventions

Intrathecal morphine

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

Saline solution (placebo)

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

Primary outcome measure

  • Presence of breakthrough pain: questionnaire [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G1X5

Contacts

More Information

Sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Last update posted

Apr 1, 2026

Last verified

Feb, 2026

Keywords

  • combined spinal epidural
  • CSE
  • intrathecal morphine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Samuel Lunenfeld Research Institute, Mount Sinai Hospital on 2026-04-01.