- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02920489
Individualized Timing of Analgesia and Effectiveness of Labor Analgesia
July 15, 2017 updated by: Dong-Xin Wang, Peking University First Hospital
Impact of Individualized Timing of Analgesia on the Effectiveness of Labor Analgesia: a Randomized Controlled Trial
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100034
- Peking University First Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 36 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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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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 Names:
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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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The most severe labor pain score during labor
Time Frame: Assessed at 24 hours after delivery
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Assessed with numeric rating scale, where 0 indicates no pain and 10 the worst pain.
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Assessed at 24 hours after delivery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of instrumental delivery
Time Frame: At the time of delivery
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Incidence of instrumental delivery
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At the time of delivery
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Incidence of Cesarean delivery
Time Frame: At the time of delivery
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Incidence of Cesarean delivery
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At the time of delivery
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Neonatal Apgar score
Time Frame: At 1 and 5 minutes after delivery
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Neonatal Apgar score
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At 1 and 5 minutes after delivery
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Maternal satisfaction with labor analgesia
Time Frame: Assessed at 24 hours after delivery
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Assessed with the Likert scale, where 1=extremely dissatisfaction, 2=dissatisfaction, 3=neither dissatisfaction nor satisfaction, 4=satisfaction, 5=extremely satisfaction.
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Assessed at 24 hours after delivery
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Persistent pain score at 24 hours and 42 days after delivery
Time Frame: At 24 hours and 42 days after delivery
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Assessed with numeric rating scale, where 0 indicates no pain and 10 the worst pain.
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At 24 hours and 42 days after delivery
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Rate of breast-feeding
Time Frame: At 24 hours and 42 days after delivery
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Rate of breast-feeding
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At 24 hours and 42 days after delivery
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Incidence of postpartum depression
Time Frame: At 42 days after delivery
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Postpartum depression will be diagnosed as Edinburgh postnatal depression scale of 10 or higher.
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At 42 days after delivery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
- Anim-Somuah M, Smyth RM, Jones L. Epidural versus non-epidural or no analgesia in labour. Cochrane Database Syst Rev. 2011 Dec 7;(12):CD000331. doi: 10.1002/14651858.CD000331.pub3.
- Alexander JM, Sharma SK, McIntire DD, Wiley J, Leveno KJ. Intensity of labor pain and cesarean delivery. Anesth Analg. 2001 Jun;92(6):1524-8. doi: 10.1097/00000539-200106000-00034.
- Panni MK, Segal S. Local anesthetic requirements are greater in dystocia than in normal labor. Anesthesiology. 2003 Apr;98(4):957-63. doi: 10.1097/00000542-200304000-00024.
- Sng BL, Leong WL, Zeng Y, Siddiqui FJ, Assam PN, Lim Y, Chan ES, Sia AT. Early versus late initiation of epidural analgesia for labour. Cochrane Database Syst Rev. 2014 Oct 9;(10):CD007238. doi: 10.1002/14651858.CD007238.pub2.
- Wassen MM, Smits LJ, Scheepers HC, Marcus MA, Van Neer J, Nijhuis JG, Roumen FJ. Routine labour epidural analgesia versus labour analgesia on request: a randomised non-inferiority trial. BJOG. 2015 Feb;122(3):344-50. doi: 10.1111/1471-0528.12854. Epub 2014 May 22.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2016
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
July 29, 2016
First Submitted That Met QC Criteria
September 29, 2016
First Posted (Estimate)
September 30, 2016
Study Record Updates
Last Update Posted (Actual)
July 19, 2017
Last Update Submitted That Met QC Criteria
July 15, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Perceptual Disorders
- Labor Pain
- Agnosia
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Anesthetics, Local
- Ropivacaine
- Sufentanil
- Dsuvia
Other Study ID Numbers
- 2016[1094]
- ChiCTR-IPR-16007976 (Registry Identifier: Chinese Clinical Trial Registry)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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