Individualized Timing of Analgesia and Effectiveness of Labor Analgesia

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Labor Pain; Analgesia, Obstetrical; Early Medical Intervention	Drug: Individualized epidural analgesia; Drug: Routine epidural analgesia	Not Applicable

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 Design

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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

Arms and Interventions

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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.	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
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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Incidence of instrumental delivery [ Time Frame: At the time of delivery ]
   Incidence of instrumental delivery
2. Incidence of Cesarean delivery [ Time Frame: At the time of delivery ]
   Incidence of Cesarean delivery
3. Neonatal Apgar score [ Time Frame: At 1 and 5 minutes after delivery ]
   Neonatal Apgar score
4. 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.
5. 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.
6. Rate of breast-feeding [ Time Frame: At 24 hours and 42 days after delivery ]
   Rate of breast-feeding
7. 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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Criteria

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.

Contacts and Locations

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Locations

China, Beijing
Peking University First Hospital
Beijing, Beijing, China, 100034

Sponsors and Collaborators

Peking University First Hospital

Investigators

Principal Investigator:	Dong-Xin Wang, MD, PhD	Peking University First Hospital

More Information

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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. Review.

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.

Panni MK, Segal S. Local anesthetic requirements are greater in dystocia than in normal labor. Anesthesiology. 2003 Apr;98(4):957-63.

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.

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. Review.

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.

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
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