Individualized Timing of Analgesia and Effectiveness of Labor Analgesia
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ClinicalTrials.gov Identifier: NCT02920489 |
Recruitment Status
:
Completed
First Posted
: September 30, 2016
Last Update Posted
: July 19, 2017
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Condition or disease | Intervention/treatment | Phase |
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Labor Pain Analgesia, Obstetrical Early Medical Intervention | Drug: Individualized epidural analgesia Drug: Routine epidural analgesia | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Impact of Individualized Timing of Analgesia on the Effectiveness of Labor Analgesia: a Randomized Controlled Trial |
Actual Study Start Date : | August 2016 |
Actual Primary Completion Date : | June 2017 |
Actual Study Completion Date : | July 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: 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.
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Drug: Individualized epidural analgesia
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.
Other Name: Individualized analgesia with sufentanil and ropivacaine
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Active Comparator: 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.
|
Drug: Routine epidural analgesia
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.
Other Name: Routine analgesia with sufentanil and ropivacaine
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- The most severe labor pain score during labor [ Time Frame: Assessed at 24 hours after delivery ]Assessed with numeric rating scale, where 0 indicates no pain and 10 the worst pain.
- Incidence of instrumental delivery [ Time Frame: At the time of delivery ]Incidence of instrumental delivery
- Incidence of Cesarean delivery [ Time Frame: At the time of delivery ]Incidence of Cesarean delivery
- Neonatal Apgar score [ Time Frame: At 1 and 5 minutes after delivery ]Neonatal Apgar score
- Maternal satisfaction with labor analgesia [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At 24 hours and 42 days after delivery ]Rate of breast-feeding
- Incidence of postpartum depression [ Time Frame: At 42 days after delivery ]Postpartum depression will be diagnosed as Edinburgh postnatal depression scale of 10 or higher.

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Ages Eligible for Study: | 18 Years to 36 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02920489
China, Beijing | |
Peking University First Hospital | |
Beijing, Beijing, China, 100034 |
Principal Investigator: | Dong-Xin Wang, MD, PhD | Peking University First Hospital |
Publications:
Responsible Party: | Dong-Xin Wang, Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital |
ClinicalTrials.gov Identifier: | NCT02920489 History of Changes |
Other Study ID Numbers: |
2016[1094] ChiCTR-IPR-16007976 ( Registry Identifier: Chinese Clinical Trial Registry ) |
First Posted: | September 30, 2016 Key Record Dates |
Last Update Posted: | July 19, 2017 |
Last Verified: | July 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by Dong-Xin Wang, Peking University First Hospital:
severity of labor pain individualized administration neuraxial labor analgesia |
Additional relevant MeSH terms:
Agnosia Labor Pain Perceptual Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Pain Ropivacaine Sufentanil Anesthetics, Local |
Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Analgesics, Opioid Narcotics Analgesics Adjuvants, Anesthesia Anesthetics, Intravenous Anesthetics, General |