Individualized Timing of Analgesia and Effectiveness of Labor Analgesia

NCT02920489 | Completed DMC

• 2 other identifiers: 2016[1094]ChiCTR-IPR-16007976
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Pain; Analgesia, Obstetrical; Early Medical Intervention

Keywords

severity of labor pain; individualized administration; neuraxial labor analgesia

Outcome Measures

Primary Outcomes (1)

• The most severe labor pain score during labor

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

  Assessed at 24 hours after delivery

Secondary Outcomes (7)

• Incidence of instrumental delivery

  At the time of delivery

• Incidence of Cesarean delivery

  At the time of delivery

• Neonatal Apgar score

  At 1 and 5 minutes after delivery

• Maternal satisfaction with labor analgesia

  Assessed at 24 hours after delivery

• Persistent pain score at 24 hours and 42 days after delivery

  At 24 hours and 42 days after delivery

Study Arms (2)

Individualized epidural analgesia

EXPERIMENTAL

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.

Drug: Individualized epidural analgesia

Routine epidural analgesia

ACTIVE COMPARATOR

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

Interventions

Individualized epidural analgesia DRUG

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.

Also known as: Individualized analgesia with sufentanil and ropivacaine

Individualized epidural analgesia

Routine epidural analgesia DRUG

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.

Also known as: Routine analgesia with sufentanil and ropivacaine

Routine epidural analgesia

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (6)

• 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.

  PMID: 22161362 BACKGROUND

• 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.

  PMID: 11375838 BACKGROUND

• 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.

  PMID: 12657859 BACKGROUND

• 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.

  PMID: 26580836 BACKGROUND

• 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.

  PMID: 25300169 BACKGROUND

• 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.

  PMID: 24849943 BACKGROUND

MeSH Terms

Conditions

Labor Pain; Agnosia

Interventions

Sufentanil; Ropivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Dong-Xin Wang, MD, PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman, Department of Anesthesiology and Critical Care Medicine

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: September 30, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: July 19, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)