Dexmedetomidine, Epidural Analgesia, Esketamine, Labor Pain, Ropivacaine, Sufentanil
Conditions
Keywords
epidural anagelsia, labor pain, sufentanil, dexmedetomidine, esketamine, ropivacaine
Brief summary
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.
Detailed description
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.
Interventions
DRUGsufentanil-ropivacaine combination
Epidural labor analgesia will be conducted using the sufentanil-ropivacaine combination (0.4 microgram/ml sufentanil + 0.072% ropivacaine).
DRUGdexmedetomidine-esketamine-ropivacaine combination 1
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).
DRUGdexmedetomidine-esketamine-ropivacaine combination 2
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).
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
a randomized, double-blind, pilot trial with three parallel-arms
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or above; 2. Single term cephalic pregnancy preparing for vaginal delivery; 3. Agreed to receive epidural labor analgesia.
Exclusion criteria
1. History of schizophrenia or epilepsy; 2. 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. 3. Relative contraindications for the use of dexmedetomidine, including prenatal bradycardia (HR\<60 beats per minute) and second-degree or higher atrioventricular block; 4. Relative contraindications for the use of esketamine, including uncontrolled hypertension (systolic blood pressure \>180 mmHg) and hyperthyroidism; 5. Not well controlled systemic diseases, including heart disease, liver disease, kidney disease, or an ASA classification \>III; 6. Other conditions that are considered unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time-weighted average score of pain intensity during labor | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of a composite of neonatal morbility | 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. |
| Dosage of epidural labor analgesics | 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. |
| Incidence of persistent pain at 42 days postpartum | 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. |
| Incidence of depression at 42 days postpartum | 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORDong-Xin Wang, MD,PhD
Peking University First Hospital
Outcome results
None listed