Individualized Timing of Analgesia and Effectiveness of Labor Analgesia

Not Applicable

Completed

• Conditions: Labor Pain; Analgesia, Obstetrical; Early Medical Intervention
• Interventions: Drug: Individualized epidural analgesia; Drug: Routine epidural analgesia

• Registration Number: NCT02920489
• Lead Sponsor: Peking University First Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2016-07-29
• Study Start: 2016-08
• Study First Submitted QC: 2016-09-29
• Study First Posted: 2016-09-30
• Primary Completion: 2017-06
• Status Verified: 2017-07
• Study Completion: 2017-07
• Last Update Submitted: 2017-07-15
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Nulliparas (aged 18-36 years) with single cephalic term pregnancy;
2. Plan to deliver vaginally, and are considered suitable for a trial of vaginal delivery by obstetricians;
3. Admitted to the delivery room;
4. Agree to receive epidural analgesia during labor.

Exclusion Criteria

1. History of psychiatric disease (indicate those that are diagnosed before or during pregnancy by psychiatrists);
2. 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.
3. Other reasons that are considered unsuitable for study participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individualized epidural analgesia	Individualized epidural analgesia	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.
Routine epidural analgesia	Routine epidural analgesia	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.

Primary Outcome Measures

Name	Time	Method
The most severe labor pain score during labor	Assessed at 24 hours after delivery	Assessed with numeric rating scale, where 0 indicates no pain and 10 the worst pain.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China