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NCT Number: NCT07145775

Dexmedetomidine-esketamine-ropivacaine Versus Sufentanil-ropivacaine for Epidural Labor Analgesia

Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine and esketamine, each has been effectively used for neuraxial anesthesia in combination with local anesthetics. Plenty of evidences show that both dexmedetomidine and esketamine, combined with ropivacaine, are also effective as the sufentanil-ropivacaine combination when used for epidural labor analgesia. This pilot trial is designed to evaluate the efficacy and safety of the dexmedetomidine-esketamine-ropivacaine versus sufentanil-ropivacaine combination for epidural labor analgesia, and to test the feasibility of a future large randomized trial.

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Key information

Conditions

Epidural Analgesia Dexmedetomidine Esketamine Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Ropivacaine Signs and Symptoms Sufentanil

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

About this study

Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine and esketamine, each has been effectively used for neuraxial anesthesia in combination with local anesthetics. Plenty of evidences show that both dexmedetomidine and esketamine, combined with ropivacaine, are also effective as the sufentanil-ropivacaine combination when used for epidural labor analgesia.

The investigators hypothesize that the dexmedetomidine-esketamine-ropivacaine combination, by avoiding sufentanil and decreasing ropivacaine concentration, may provide non-inferior analgesia with less harmful effect on neonatal outcomes when compared with the sufentanil-ropivacaine combination. This pilot trial is designed to evaluate the efficacy and safety of the dexmedetomidine-esketamine-ropivacaine versus sufentanil-ropivacaine combination for epidural labor analgesia, and to test the feasibility of a future large randomized trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18 years or above;
  • Single term cephalic pregnancy preparing for vaginal delivery;
  • Agreed to receive epidural labor analgesia.

Exclusion criteria

  • History of schizophrenia or epilepsy;
  • Presence of contraindications for epidural analgesia, including: (1) history of infectious disease of the central nervous system (poliomyelitis, cerebrospinal meningitis, encephalitis, etc.); (2) history of spinal or intra-spinal disease (trauma or surgery of spinal column, intra-spinal canal mass, etc.); (3) systemic infection (sepsis); (4) skin or soft tissue infection at the site of epidural puncture; (5) coagulopathy.
  • Relative contraindications for the use of dexmedetomidine, including prenatal bradycardia (HR<60 beats per minute) and second-degree or higher atrioventricular block;
  • Relative contraindications for the use of esketamine, including uncontrolled hypertension (systolic blood pressure >180 mmHg) and hyperthyroidism;
  • Not well controlled systemic diseases, including heart disease, liver disease, kidney disease, or an ASA classification >III;
  • Other conditions that are considered unsuitable for study participation.

Treatment and study plan

sufentanil-ropivacaine combination

Drug

Epidural labor analgesia will be conducted using the sufentanil-ropivacaine combination (0.4 microgram/ml sufentanil + 0.072% ropivacaine).

Other names: epidural analgesia using the sufentanil-ropivacaine combination

dexmedetomidine-esketamine-ropivacaine combination 1

Drug

Epidural labor analgesia will be conducted using the dexmedetomidine-esketamine-ropivacaine combination 1 (0.4 microgram/ml dexmedetomidine + 0.15 mg/ml esketamine + 0.036% ropivacaine).

Other names: epidural analgesia using the dexmedetomidine-esketamine-ropivacaine combination 1

dexmedetomidine-esketamine-ropivacaine combination 2

Drug

Epidural labor analgesia will be conducted using the dexmedetomidine-esketamine-ropivacaine combination 2 (0.4 microgram/ml dexmedetomidine + 0.2 mg/ml esketamine + 0.036% ropivacaine).

Other names: epidural analgesia using the dexmedetomidine-esketamine-ropivacaine combination 2

Primary outcomes

  1. Time-weighted average score of pain intensity during labor

    Time frame: From start of analgesia to 2 hours after childbirth

    Pain intensity will be assessed with the numeric rating scale (an 11-point scale where 0=no pain and 10=the worst pain) at the fllowing timepoints: before analgesia, 10 and 30 minutes after loading dose, every hour during labor, full cervical dilation, immedlately after childbirth, and 2 hours after childbirth. Time-weighted average score will be calculated by summarizing the product of time interval between two adjacent pain scores multiplied by the average of corresponding pain scores, and then divided by the duration of epidural analgesia.

Secondary outcomes

  1. Incidence of a composite of neonatal morbility

    Time frame: From immediate childbirth to 24 hours after childbirth

    Neonatal morbidity includes occurrence of any of the following events: 1-minute Apgar score <7, 5-minute Apgar score <7, neonatal umbilical artery blood gas PH<7.1, need for immediate assisted ventilation after birth, or admission to the neonatal ward or neonatal intensive care unit within 24 hours after birth.

  2. Dosage of epidural labor analgesics

    Time frame: From start of analgesia to end of third stage or childbirth

    Including number of demanded boluses, number of delivered boluses, total volume, and hourly volume.

  3. Incidence of persistent pain at 42 days postpartum

    Time frame: At 42 days postpartum

    Defined as a numeric rating scale of pain (an 11-point scale where 0=no pain and 10=the worst pain) at rest of 1 point or higher that persisted since childbirth.

  4. Incidence of depression at 42 days postpartum

    Time frame: At 42 days postpartum

    Depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). An Edinburgh depression score of 10 points or higher indicates presence of depressive symptoms.

Other outcomes

  1. Scores of pain intensity at various timepoints during labor

    Time frame: Up to 2 hours after childbirth

    Pain intensity will be assessed with the numeric rating scale (an 11-point scale where 0=no pain and 10=the worst pain) at the fllowing timepoints: before analgesia, 10 and 30 minutes after loading dose, every hour during labor, full cervical dilation, immedlately after childbirth, and 2 hours after childbirth.

  2. Scores of sedation at various timepoints during labor

    Time frame: Up to 2 hours after childbirth

    Maternal sedation will be assessed with the Ramsay Agitation-Sedation Scale (1=anxious and agitated or restless; 2=awake, quiet and cooperative; 3=drowsy but responding to verbal commands; 4=lightly asleep but responding to touch or pain; 5=asleep but slowly responding to touch or pain; 6=deeply asleep and does not respond) at the fllowing timepoints: before analgesia, 10 and 30 minutes after loading dose, every hour during labor, full cervical dilation, immedlately after childbirth, and 2 hours after childbirth.

  3. Degree of lower limb motor block at various timepoints during labor

    Time frame: Up to 2 hours after childbirth

    Lower limb motor block will be assessed with the modified Bromage scale (0=no motor loss; 1=inability to flex the hip; 2=inability to flex the knee; 3=inability to flex the ankles) at the fllowing timepoints: before analgesia, 10 and 30 minutes after loading dose, every hour during labor, full cervical dilation, immedlately after childbirth, and 2 hours after childbirth.

  4. Duration of each stage of labor

    Time frame: From start of labor to end of third stage

    Including durations of the first, second, and third stages of labor.

  5. Mode of delivery

    Time frame: From start of labor to childbirth

    Mode of delivery

  6. Subjective sleep quality during the first night after childbirth

    Time frame: Up to 24 hours after childbirth

    Subjective sleep quality will be assessed with the numeric rating scale (an 11-point scale where 0=the best sleep and 10=the worst sleep) in the first morning after childbirth.

  7. Time to breastfeeding

    Time frame: Up to 24 hours after childbirth

    Time to breastfeeding

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

Dexmedetomidine-esketamine-ropivacaine Versus Sufentanil-ropivacaine Combination for Epidural Labor Analgesia and Neonatal Outcomes: a Pilot Randomized Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2025
Registry last updated
Apr 13, 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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