A Phase 4 interventional study of sufentanil-ropivacaine combination and dexmedetomidine-esketamine-ropivacaine combination 1 in Epidural Analgesia, Labor Pain and Sufentanil, sponsored by Peking University First Hospital. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Peking University First Hospital · Phase 4, Interventional, and Prevention
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.
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.
396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.
This study's enrollment of 300 is above the median of 100 across 326 interventional studies indexed under Labor Pain.
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Epidural analgesia will be conducted with the sufentanil-ropivacaine combination (0.4 microgram/ml sufentanil + 0.072% ropivacaine; 100 microgram sufentanil + 18 ml 1% ropivacaine, diluted with normal saline to 250 ml).
Drug: sufentanil-ropivacaine combination
Epidural analgesia will be conducted with the dexmedetomidine-esketamine-ropivacaine combination 1 (0.4 microgram/ml dexmedetomidine + 0.15 mg/ml esketamine + 0.036% ropivacaine; 100 microgram dexmedetomidine + 37.5 mg esketamine + 9 ml 1% ropivacaine, diluted with normal saline to 250 ml).
Drug: dexmedetomidine-esketamine-ropivacaine combination 1
Epidural analgesia will be conducted with the dexmedetomidine-esketamine-ropivacaine combination 2 (0.4 microgram/ml dexmedetomidine + 0.2 mg/ml esketamine + 0.036% ropivacaine; 100 microgram dexmedetomidine + 50 mg esketamine + 9 ml 1% ropivacaine, diluted with normal saline to 250 ml).
Drug: dexmedetomidine-esketamine-ropivacaine combination 2
Epidural labor analgesia will be conducted using the sufentanil-ropivacaine combination (0.4 microgram/ml sufentanil + 0.072% ropivacaine).
Also known as: epidural analgesia using the sufentanil-ropivacaine combination
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).
Also known as: epidural analgesia using the dexmedetomidine-esketamine-ropivacaine combination 1
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).
Also known as: epidural analgesia using the dexmedetomidine-esketamine-ropivacaine combination 2
Time-weighted average score of pain intensity during labor
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.
Time frame: From start of analgesia to 2 hours after childbirth
Incidence of a composite of neonatal morbility
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.
Time frame: From immediate childbirth to 24 hours after childbirth
Dosage of epidural labor analgesics
Including number of demanded boluses, number of delivered boluses, total volume, and hourly volume.
Time frame: From start of analgesia to end of third stage or childbirth
Incidence of persistent pain 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.
Time frame: At 42 days postpartum
Incidence of depression 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.
Time frame: At 42 days postpartum
Scores of pain intensity at various timepoints during labor
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 frame: Up to 2 hours after childbirth
Scores of sedation at various timepoints during labor
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.
Time frame: Up to 2 hours after childbirth
Degree of lower limb motor block at various timepoints during labor
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.
Time frame: Up to 2 hours after childbirth
Duration of each stage of labor
Including durations of the first, second, and third stages of labor.
Time frame: From start of labor to end of third stage
Mode of delivery
Mode of delivery
Time frame: From start of labor to childbirth
Subjective sleep quality during the first night 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.
Time frame: Up to 24 hours after childbirth
Time to breastfeeding
Time to breastfeeding
Time frame: Up to 24 hours after childbirth
Plan to share: No
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Peking University First Hospital