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

ConditionLabor Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorSamuel Lunenfeld Research Institute, Mount Sinai Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intrathecal morphine

    Drug

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

  • Saline solution (placebo)

    Other intervention

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

Treatment groups

182 Participants
are divided into 2 treatment groups
Group A: MorphineActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
24 hours

Secondary outcomes

1

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.

Time frame
24 hours
2

Epidural medication consumption (milliliters)

The overall consumption of epidural medication throughout labour, in milliliters.

Time frame
24 hours
3

Epidural pump settings: questionnaire

Any adjustments made to the programmed intermittent bolus settings of the epidural pump will be recorded.

Time frame
24 hours
4

Presence of fetal heart rate anomalies: questionnaire

The presence of any fetal heart rate anomalies will be recorded

Time frame
24 hours

Other outcomes

Sponsors and contacts

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