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NCT Number: NCT06572241

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

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.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location status: Recruiting

Location contact

Afsheen Nasir, MD

SUB_INVESTIGATOR

Binu Jacob, PhD

SUB_INVESTIGATOR

Kristi Downey, MSc

SUB_INVESTIGATOR

Narinder Singh, MD

SUB_INVESTIGATOR

Naveed Siddiqui, MD

CONTACT

[email protected]

416-586-5270

Ronald George, MD

SUB_INVESTIGATOR

About this study

The addition of morphine to a combination of bupivacaine and lipophilic opioids (fentanyl) for the spinal component of CSE for labor analgesia has been shown to increase the duration of analgesia. A meta-analysis by Al-Kazwini and coworkers suggests a possible beneficial prolonging effect of adding morphine to spinal analgesia, however, the authors concluded that more adequately powered randomized controlled trials (RCTs) are required to determine the benefits and harms of intrathecal morphine (ITM).

This prolonged duration of action of ITM may reduce the need for frequent top-ups, which could alleviate nursing and anesthesiologist workload and enhance maternal satisfaction. An RCT conducted by Vasudevan and coworkers has concluded that the addition of 100 mcg ITM along with bupivacaine and fentanyl reduced the incidence of breakthrough pain in labor. Another dose-finding study comparing 50 and 100 mcg of ITM as a component of CSE labor analgesia concluded that 100 mcg of ITM significantly lowers the local anesthetic consumption and shorter duration of the first stage of labor without any significant difference in adverse effects. The RCT by Vasudevan et al. had a small sample size, enrolled mixed parity patients, and utilized continuous infusion for labor analgesia maintenance.

Hence, the investigators plan to conduct adequately powered RCT enrolling only primigravidae patients, which tend to have more prolonged labor than multiparous and programmed intermittent epidural bolus (PIEB) with patient-controlled epidural analgesia (PCEA) will be used, which is a more contemporary labor maintenance technique.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intrathecal morphine

Drug

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

Other names: Morphine

Saline solution (placebo)

Other

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

Other names: saline

Primary outcomes

  1. Presence of breakthrough pain: questionnaire

    Time frame: 24 hours

    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.

Secondary outcomes

  1. Time to first episode of breakthrough pain in minutes

    Time frame: 24 hours

    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.

  2. Epidural medication consumption (milliliters)

    Time frame: 24 hours

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

  3. Epidural pump settings: questionnaire

    Time frame: 24 hours

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

  4. Presence of fetal heart rate anomalies: questionnaire

    Time frame: 24 hours

    The presence of any fetal heart rate anomalies will be recorded

  5. Presence of Cesarean delivery: questionnaire

    Time frame: 24 hours

    The presence of Cesarean delivery will be recorded

  6. Analgesic consumption post-delivery: questionnaire

    Time frame: 24 hours

    Presence of analgesic consumption post-delivery will be recorded.

  7. Presence of pruritis: questionnaire

    Time frame: 24 hours

    The presence of pruritis (yes or no) will be recorded.

  8. Presence of nausea: questionnaire

    Time frame: 24 hours

    The presence of nausea(yes or no) will be recorded.

  9. Presence of vomiting: questionnaire

    Time frame: 24 hours

    The presence of vomiting(yes or no) will be recorded.

  10. Presence of sedation: questionnaire

    Time frame: 24 hours

    The presence of sedation(yes or no) will be recorded.

  11. Presence of respiratory depression: questionnaire

    Time frame: 24 hours

    The presence of respiratory depression(yes or no) will be recorded.

  12. Apgar score at 1 minute

    Time frame: 1 minute

    Apgar score recorded by the respiratory therapist, nurse or midwife at 1 minute of life.

  13. Apgar score at 5 minutes

    Time frame: 5 minutes

    Apgar score recorded by the respiratory therapist, nurse or midwife at 5 minutes of life.

  14. Umbilical artery pH

    Time frame: 24 hours

    Lab results for umbilical artery pH

  15. Umbilical vein pH

    Time frame: 24 hours

    Lab results for umbilical vein pH

  16. Satisfaction: questionnaire

    Time frame: 24 hours

    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.

  17. Obstetric Quality of Recovery-10 (ObsQoR-10) score 24 hours

    Time frame: 24 hours

    ObsQoR-10 score at 24 hours. There are 10 questions, and the results are tabulated out of 100. The higher the overall score out of 100, the better quality of recovery a patient is experiencing.

Study contacts

Contact information is provided by the study sponsor or research team.

Naveed Siddiqui, MD

CONTACT

[email protected]

416-586-5270

Sponsors and collaborators

Lead sponsor

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2024
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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