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Individualized Timing of Analgesia and Effectiveness of Labor Analgesia

Primary Purpose

Labor Pain, Analgesia, Obstetrical, Early Medical Intervention

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Individualized epidural analgesia
Routine epidural analgesia
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Labor Pain focused on measuring severity of labor pain, individualized administration, neuraxial labor analgesia

Eligibility Criteria

18 Years - 36 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Individualized epidural analgesia

Routine epidural analgesia

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The most severe labor pain score during labor
Assessed with numeric rating scale, where 0 indicates no pain and 10 the worst pain.

Secondary Outcome Measures

Incidence of instrumental delivery
Incidence of instrumental delivery
Incidence of Cesarean delivery
Incidence of Cesarean delivery
Neonatal Apgar score
Neonatal Apgar score
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.
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.
Rate of breast-feeding
Rate of breast-feeding
Incidence of postpartum depression
Postpartum depression will be diagnosed as Edinburgh postnatal depression scale of 10 or higher.

Full Information

First Posted
July 29, 2016
Last Updated
July 15, 2017
Sponsor
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02920489
Brief Title
Individualized Timing of Analgesia and Effectiveness of Labor Analgesia
Official Title
Impact of Individualized Timing of Analgesia on the Effectiveness of Labor Analgesia: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Analgesia, Obstetrical, Early Medical Intervention
Keywords
severity of labor pain, individualized administration, neuraxial labor analgesia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Individualized epidural analgesia
Arm Type
Experimental
Arm Description
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.
Arm Title
Routine epidural analgesia
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Individualized epidural analgesia
Other Intervention Name(s)
Individualized analgesia with sufentanil and ropivacaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Routine epidural analgesia
Other Intervention Name(s)
Routine analgesia with sufentanil and ropivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
The most severe labor pain score during labor
Description
Assessed with numeric rating scale, where 0 indicates no pain and 10 the worst pain.
Time Frame
Assessed at 24 hours after delivery
Secondary Outcome Measure Information:
Title
Incidence of instrumental delivery
Description
Incidence of instrumental delivery
Time Frame
At the time of delivery
Title
Incidence of Cesarean delivery
Description
Incidence of Cesarean delivery
Time Frame
At the time of delivery
Title
Neonatal Apgar score
Description
Neonatal Apgar score
Time Frame
At 1 and 5 minutes after delivery
Title
Maternal satisfaction with labor analgesia
Description
Assessed with the Likert scale, where 1=extremely dissatisfaction, 2=dissatisfaction, 3=neither dissatisfaction nor satisfaction, 4=satisfaction, 5=extremely satisfaction.
Time Frame
Assessed at 24 hours after delivery
Title
Persistent pain score at 24 hours and 42 days after delivery
Description
Assessed with numeric rating scale, where 0 indicates no pain and 10 the worst pain.
Time Frame
At 24 hours and 42 days after delivery
Title
Rate of breast-feeding
Description
Rate of breast-feeding
Time Frame
At 24 hours and 42 days after delivery
Title
Incidence of postpartum depression
Description
Postpartum depression will be diagnosed as Edinburgh postnatal depression scale of 10 or higher.
Time Frame
At 42 days after delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD, PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22161362
Citation
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.
Results Reference
background
PubMed Identifier
11375838
Citation
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.
Results Reference
background
PubMed Identifier
12657859
Citation
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.
Results Reference
background
PubMed Identifier
26580836
Citation
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.
Results Reference
background
PubMed Identifier
25300169
Citation
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.
Results Reference
background
PubMed Identifier
24849943
Citation
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.
Results Reference
background

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Individualized Timing of Analgesia and Effectiveness of Labor Analgesia

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