Quality of Labour Epidural Analgesia With Intrathecal Morphine as a Component of Combined Spinal Epidural: a Double-blinded Randomized Control Trial
NCT Number: NCT06572241
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Labor Pain
Interventions: DRUG: Intrathecal morphine|OTHER: Saline solution (placebo)
Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sex: FEMALE
Age: ADULT
Enrollment: 182
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2025-09
Locations: Mount Sinai Hospital, Toronto, Ontario, M5G1X5, Canada

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.

Primary Outcome Measures: 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 Outcome Measures: Time to first episode of breakthrough pain in minutes, The amount of time in minutes to the first recorded episode of breakthrough pain, 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|Epidural medication consumption (milliliters), The overall consumption of epidural medication throughout labour, in milliliters., 24 hours|Epidural pump settings: questionnaire, Any adjustments made to the programmed intermittent bolus settings of the epidural pump will be recorded., 24 hours|Presence of fetal heart rate anomalies: questionnaire, The presence of any fetal heart rate anomalies will be recorded, 24 hours|Presence of Cesarean delivery: questionnaire, The presence of Cesarean delivery will be recorded, 24 hours|Analgesic consumption post-delivery: questionnaire, Presence of analgesic consumption post-delivery will be recorded., 24 hours|Presence of pruritis: questionnaire, The presence of pruritis (yes or no) will be recorded., 24 hours|Presence of nausea: questionnaire, The presence of nausea(yes or no) will be recorded., 24 hours|Presence of vomiting: questionnaire, The presence of vomiting(yes or no) will be recorded., 24 hours|Presence of sedation: questionnaire, The presence of sedation(yes or no) will be recorded., 24 hours|Presence of respiratory depression: questionnaire, The presence of respiratory depression(yes or no) will be recorded., 24 hours|Apgar score at 1 minute, Apgar score recorded by the respiratory therapist, nurse or midwife at 1 minute of life., 1 minute|Apgar score at 5 minutes, Apgar score recorded by the respiratory therapist, nurse or midwife at 5 minutes of life., 5 minutes|Umbilical artery pH, Lab results for umbilical artery pH, 24 hours|Umbilical vein pH, Lab results for umbilical vein pH, 24 hours|Satisfaction: questionnaire, Post-delivery, patients will be asked how satisfied they were with their labour analgesia from 0-10, where 0 is no pain and 10 is the worst pain imaginable., 24 hours