Clinical trial NCT02920489: 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
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Analgesia, Obstetrical
Early Medical Intervention
Keywords: severity of labor pain
individualized administration
neuraxial labor analgesia
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: The most severe labor pain score during labor
timeFrame: Assessed at 24 hours after delivery
Secondary outcomes:
measure: Incidence of instrumental delivery
timeFrame: At the time of delivery
measure: Incidence of Cesarean delivery
timeFrame: At the time of delivery
measure: Neonatal Apgar score
timeFrame: At 1 and 5 minutes after delivery
measure: Maternal satisfaction with labor analgesia
timeFrame: Assessed at 24 hours after delivery
measure: Persistent pain score at 24 hours and 42 days after delivery
timeFrame: At 24 hours and 42 days after delivery
measure: Rate of breast-feeding
timeFrame: At 24 hours and 42 days after delivery
measure: Incidence of postpartum depression
timeFrame: At 42 days after delivery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Peking University First Hospital
name: Dong-Xin Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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;2014(10):CD007238. doi: 10.1002/14651858.CD007238.pub2.
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.