The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia

Pain Clinical Trial

— EIEBFLA  

Official title:

The Effects of Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Fever for Labor Analgesia in Primiparous Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01708668
• Other study ID #: NJMCHH-2012-A010
• Secondary ID: 08NMUM063YKK0811
• Status: Recruiting
• Phase: N/A
• First received: October 7, 2012
• Last updated: January 14, 2015
• Start date: October 2012
• Est. completion date: June 2017

Study information

• Verified date: January 2015
• Source: Nanjing Medical University
• Contact: Shanwu Feng, M.D.
• Phone: +86 25 52226112
• Email: shanwufeng[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Epidural analgesia is associated with maternal intra-partum fever during labor. Intermittent epidural injections appear to reduce the incidence of maternal intra-partum fever compared to continuous epidural infusion during labor analgesia. However, the optimal combination of bolus volume and administrating interval has not yet been compared. The purpose of this prospective, randomized, double-blind trial was to determine how intermittent epidural bolus reduced the incidence of maternal intra-partum fever compared with continuous epidural infusion during labor.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: June 2017
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• Nulliparous women

• Required labor analgesia

• Chinese

• Spontaneous labor

Exclusion Criteria:

• Contraindications for epidural analgesia

• Allergic to opioids and/or local anesthetics

• Failed to performing epidural catheterization

• Organic dysfunction

• Those who were not willing to or could not finish the whole study at any time

• Using or used in the past 14 days of the monoamine oxidase inhibitors

• Alcohol addictive or narcotic dependent patients

• Subjects with a nonvertex presentation or scheduled induction of labor

• Twin gestation and breech presentation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Pain
• Neurologic Manifestations
• Pain
• Pathological Conditions, Signs and Symptoms
• Signs and Symptoms

Intervention

Procedure:
• Epidural analgesia

• Combined spinal-epidural analgesia

• Continuous epidural infusion

• Intermittent epidural bolus

Locations

Country	Name	City	State
China	Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
ShanWu Feng, M.D.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal oral and tympanic temperature		At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)	Yes
Secondary	Maternal serum Interleukin-1ß		At time of placental delivery and 3, 6 and 12 hours later	No
Secondary	Cord serum Interleukin-1ß		At time of placental delivery	No
Secondary	Maternal serum Interleukin-6		At time of placental delivery and 3, 6 and 12 hours later	No
Secondary	Cord serum Interleukin-6		At time of placental delivery	No
Secondary	Maternal serum Interleukin-10		At time of placental delivery and 3, 6 and 12 hours later	No
Secondary	Cord serum Interleukin-10		At time of placental delivery	No
Secondary	Maternal serum tumor necrosis factor-a		At time of placental delivery and 3, 6 and 12 hours later	No
Secondary	Cord serum tumor necrosis factor-a		At time of placental delivery	No
Secondary	Regression and correlation analyses between maternal and cord serum cytokines		At twelve hours postpartum	No
Secondary	Placental routine pathologic examination		At time of placental delivery	No
Secondary	Maternal and cord blood gase analysis		At time of placental delivery	No
Secondary	Maternal modified Bromage scale and visual analogue scale		At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours)	No
Secondary	Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture		At two hours postpartum	No
Secondary	Rates of cesarean delivery and instrument-assisted delivery		At time of placental delivery	Yes
Secondary	Indications of cesarean delivery		Initiation of analgesia to placental delivery (approximately 8 hours)	No
Secondary	Duration of analgesia		Initiation of analgesia to 2 h postpartum (approximately 10 hours)	Yes
Secondary	Durations of labor stages		From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours)	Yes
Secondary	Maternal satisfaction with analgesia		At two hours postpartum	No
Secondary	Use of oxytocin after analgesia		At twenty-four hours postpartum	Yes
Secondary	Low back pain at 3 months after vaginal delivery		At the third month after vaginal delivery	Yes
Secondary	Breastfeeding success at 6 weeks after vaginal delivery		At the sixth week after successful delivery	Yes
Secondary	Neonatal Apgar scale		At the first and fifth minutes after baby was born	Yes
Secondary	Incidence of maternal side effects		Initiation of analgesia to 2 hour postpartum (approximately 10 hours)	Yes
Secondary	Neonatal Neurologic and Adaptive Capacity Score		At 30 min, 2 h, and 24 h after baby was born	Yes
Secondary	Maximal oxytocin dose		At twenty-four hours postpartum	Yes
Secondary	Neonatal sepsis evaluation		At 30 min after baby was born	Yes
Secondary	Neonatal antibiotic treatment		One week after baby was born	Yes
Secondary	Maternal heart rate, respiratory rate, and blood pressure		At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)	Yes
Secondary	Highest thoracic sensory level to alcohol		At three hours after initiation of analgesia	Yes
Secondary	Uterine contraction		At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)	Yes
Secondary	Neonatal rectal temperature		At delivery, 30 min after delivery, and 1 h after delivery	Yes
Secondary	Fetal heart rate		From initiation of analgesia to delivery (approximately 8 hours)	Yes
Secondary	Maternal group B streptococcus (GBS) colonization		At time of initiation of analgesia	Yes
Secondary	Number of vaginal examinations, duration from rupture of the membranes to delivery, mode of membranes ruptured		From initiation of analgesia to delivery (approximately 8 hours)	Yes
Secondary	Neonatal weight		At delivery	No
Secondary	Uterine artery, umbilical artery and vein, fetus middle cerebral artery by ultrasound		At time of initiation of analgesia and hourly thereafter until delivery (approximately 8 hours)	Yes
Secondary	Maternal serum epinephrine, norepinephrine, insulin, glucagon, corticotropin releasing hormone, adrenocorticotropic hormone, cortisol, blood glucose, oxytocin, prostaglandin E2 and prostaglandin F2 alpha		At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)	No
Secondary	Maternal postpartum depression		At time of delivery and daily thereafter until 1 year postpartum (approximately 1 year)	Yes