Individualized Timing of Analgesia and Effectiveness of Labor Analgesia

Labor Pain Clinical Trial

Official title:

Impact of Individualized Timing of Analgesia on the Effectiveness of Labor Analgesia: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02920489
• Other study ID #: 2016[1094]
• Secondary ID: ChiCTR-IPR-16007
• Status: Completed
• Phase: N/A
• First received: July 29, 2016
• Last updated: July 15, 2017
• Start date: August 2016
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia, Obstetrical
• Early Medical Intervention
• Labor Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View 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. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of instrumental delivery	Incidence of instrumental delivery	At the time of delivery
Secondary	Incidence of Cesarean delivery	Incidence of Cesarean delivery	At the time of delivery
Secondary	Neonatal Apgar score	Neonatal Apgar score	At 1 and 5 minutes after delivery
Secondary	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.	Assessed at 24 hours after delivery
Secondary	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.	At 24 hours and 42 days after delivery
Secondary	Rate of breast-feeding	Rate of breast-feeding	At 24 hours and 42 days after delivery
Secondary	Incidence of postpartum depression	Postpartum depression will be diagnosed as Edinburgh postnatal depression scale of 10 or higher.	At 42 days after delivery