Individualized Timing of Analgesia and Effectiveness of Labor Analgesia

Study Overview
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Brief Summary
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Neuraxial analgesia is the gold standard to relieve labor pain. A recent Practice guidelines for obstetric anesthesia suggests that neuraxial analgesia should be provided in the early stage of labor (cervical dilation < 5 cm) or on a individualized basis. The purpose of this randomized controlled trial is to investigate whether neuraxial labor analgesia administered on an individualized basis can improve analgesia quality and maternal satisfaction.

Detailed Description
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Neuraxial analgesia is the gold standard to relieve labor pain. It also helps to attenuate maternal anxiety and improve maternal satisfaction. A recent Practice guidelines for obstetric anesthesia suggests that neuraxial analgesia should be provided in the early stage of labor (cervical dilation < 5 cm) or, for some special patients, be provided on a individualized basis. Studies showed that, when compared with late administration, early administration of labor analgesia resulted in equivocal findings for spontaneous, instrumented, and cesarean delivery. The investigators hypothesize that neuraxial labor analgesia provided on an individualized basis will further improve analgesia quality and maternal satisfaction. The purpose of this randomized controlled trial is to investigate whether neuraxial labor analgesia administered on an individualized basis can improve analgesia quality and maternal satisfaction.

Official Title
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Impact of Individualized Timing of Analgesia on the Effectiveness of Labor Analgesia: a Randomized Controlled Trial

Conditions
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Labor Pain, Analgesia, Obstetrical, Early Medical Intervention

Intervention / Treatment
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* Drug: Individualized epidural analgesia
* Drug: Routine epidural analgesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nulliparas (aged 18-36 years) with single cephalic term pregnancy; Plan to deliver vaginally, and are considered suitable for a trial of vaginal delivery by obstetricians; Admitted to the delivery room; Agree to receive epidural analgesia during labor. Exclusion Criteria: History of psychiatric disease (indicate those that are diagnosed before or during pregnancy by psychiatrists); Presence of contraindications to epidural analgesia, which includes: (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. Other reasons that are considered unsuitable for study participation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized epidural analgesia<br>Epidural catheterization will be performed after the beginning of the first stage of labor. Epidural analgesia will begin when asked by parturients and the numeric rating scale of pain is 5 or higher. A loading dose (10 ml mixture of 0.1% ropivacaine and 0.5 ug/ml sufentanil) will be administered through the epidural catheter. After a 20-minute observation, a patient-controlled analgesia pump (containing a mixture of 0.08% ropivacaine and 0.4 ug/ml sufentanil) will be connected to the epidural catheter and programmed to deliver a 6-ml bolus with a 20-minute lockout interval and a 4 ml/h background infusion. Analgesia will be terminated at the end of the third stage of labor. | Drug: Individualized epidural analgesia<br>* Epidural analgesia will begin when asked by the parturients (during the first stage of labor) and the numeric rating scale is 5 or higher. Analgesia will be terminated at the end of the third stage of labor.<br>* Other names: Individualized analgesia with sufentanil and ropivacaine;|
| Active Comparator: Routine epidural analgesia<br>Epidural catheterization will be performed after the beginning of the first stage of labor and the cervix is dilated to 1 cm or more. Epidural analgesia will then begin. A loading dose (10 ml mixture of 0.1% ropivacaine and 0.5 ug/ml sufentanil) will be administered through the epidural catheter. After a 20-minute period observation, a patient-controlled analgesia pump (containing a mixture of 0.08% ropivacaine and 0.4 ug/ml sufentanil) will be connected to the epidural catheter and programmed to deliver a 6-ml bolus with a 20-minute lockout interval and a 4 ml/h background infusion. Analgesia will be terminated at the end of the third stage of labor. | Drug: Routine epidural analgesia<br>* Epidural analgesia will begin when asked by the parturients (during the first stage of labor) and the cervix is dilated to 1 cm or more. Analgesia will be terminated at the end of the third stage of labor.<br>* Other names: Routine analgesia with sufentanil and ropivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The most severe labor pain score during labor | Assessed with numeric rating scale, where 0 indicates no pain and 10 the worst pain. | Assessed at 24 hours after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of instrumental delivery | Incidence of instrumental delivery | At the time of delivery | 
| Incidence of Cesarean delivery | Incidence of Cesarean delivery | At the time of delivery | 
| Neonatal Apgar score | Neonatal Apgar score | At 1 and 5 minutes after delivery | 
| Maternal satisfaction with labor analgesia | Assessed with the Likert scale, where 1=extremely dissatisfaction, 2=dissatisfaction, 3=neither dissatisfaction nor satisfaction, 4=satisfaction, 5=extremely satisfaction. | Assessed at 24 hours after delivery | 
| Persistent pain score at 24 hours and 42 days after delivery | Assessed with numeric rating scale, where 0 indicates no pain and 10 the worst pain. | At 24 hours and 42 days after delivery | 
| Rate of breast-feeding | Rate of breast-feeding | At 24 hours and 42 days after delivery | 
| Incidence of postpartum depression | Postpartum depression will be diagnosed as Edinburgh postnatal depression scale of 10 or higher. | At 42 days after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severity of labor pain, individualized administration, neuraxial labor analgesia