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Labor PainNCT02920489

Individualized Timing of Analgesia and Effectiveness of Labor Analgesia

A study testing Individualized epidural analgesia and Routine epidural analgesia in people with Labor Pain and Analgesia, Obstetrical, run by Peking University First Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 36 years, women only
What is being tested?
Individualized epidural analgesia and Routine epidural analgesia
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
Aug 2016to Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 36 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Individualized epidural analgesia, Routine epidural analgesia
Keywords
severity of labor pain, individualized administration, neuraxial labor analgesia
Medical subject headings
Labor Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individualized epidural analgesiaDrug

    Also called Individualized analgesia with sufentanil and ropivacaine

    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.

  • Routine epidural analgesiaDrug

    Also called Routine analgesia with sufentanil and ropivacaine

    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.

Study groups in NCT02920489
Study groupRoleWhat they receive
Individualized epidural analgesiaExperimentalEpidural 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.
Receives: Drug: Individualized epidural analgesia
Routine epidural analgesiaActive comparatorEpidural 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.
Receives: Drug: Routine epidural analgesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The most severe labor pain score during labor

    Assessed with numeric rating scale, where 0 indicates no pain and 10 the worst pain.

    Measured: Assessed at 24 hours after delivery

Secondary outcomes (7)

  1. Incidence of instrumental delivery

    Incidence of instrumental delivery

    Measured: At the time of delivery

  2. Incidence of Cesarean delivery

    Incidence of Cesarean delivery

    Measured: At the time of delivery

  3. Neonatal Apgar score

    Neonatal Apgar score

    Measured: At 1 and 5 minutes after delivery

  4. 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.

    Measured: Assessed at 24 hours after delivery

  5. 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.

    Measured: At 24 hours and 42 days after delivery

  6. Rate of breast-feeding

    Rate of breast-feeding

    Measured: At 24 hours and 42 days after delivery

  7. Incidence of postpartum depression

    Postpartum depression will be diagnosed as Edinburgh postnatal depression scale of 10 or higher.

    Measured: At 42 days after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionJun 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02920489
Sponsor's protocol ID
2016[1094]
Other IDs
ChiCTR-IPR-16007976
Status last verified
Jul 2017
First submitted
29 Jul 2016
Last updated
19 Jul 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 22161362

  • 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.

    PubMed 11375838

  • 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.

    PubMed 12657859

  • 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.

    PubMed 26580836

  • 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;2014(10):CD007238. doi: 10.1002/14651858.CD007238.pub2.

    PubMed 25300169

  • 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.

    PubMed 24849943

Questions about this trial

What is this clinical trial studying?

A study testing Individualized epidural analgesia and Routine epidural analgesia in people with Labor Pain and Analgesia, Obstetrical, run by Peking University First Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The most severe labor pain score during labor (time frame: Assessed at 24 hours after delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02920489, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.

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