The Effects of Intermittent Epidural Bolus on Fever During Labor Analgesia
Not Applicable
- Conditions
- Labor PainSigns and SymptomsPainPathological Conditions, Signs and SymptomsNeurologic Manifestations
- Interventions
- Procedure: Epidural analgesiaProcedure: Combined spinal-epidural analgesiaProcedure: Continuous epidural infusionProcedure: Intermittent epidural bolus
- Registration Number
- NCT01708668
- Lead Sponsor
- ShanWu Feng, M.D.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 12000
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Epidural analgesia Epidural analgesia (EA) with continuous epidural infusion(CEI) 2 Continuous epidural infusion Combined spinal-epidural analgesia (CSEA) with continuous epidural infusion(CEI) 3 Epidural analgesia Epidural analgesia (EA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes) 6 Combined spinal-epidural analgesia Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes) 8 Combined spinal-epidural analgesia Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes) 1 Continuous epidural infusion Epidural analgesia (EA) with continuous epidural infusion(CEI) 3 Intermittent epidural bolus Epidural analgesia (EA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes) 7 Combined spinal-epidural analgesia Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes) 7 Intermittent epidural bolus Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes) 6 Intermittent epidural bolus Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 2.5 mL bolused every 15 minutes) 2 Combined spinal-epidural analgesia Combined spinal-epidural analgesia (CSEA) with continuous epidural infusion(CEI) 4 Epidural analgesia Epidural analgesia (EA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes) 5 Epidural analgesia Epidural analgesia (EA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes) 5 Intermittent epidural bolus Epidural analgesia (EA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes) 8 Intermittent epidural bolus Combined spinal-epidural analgesia (CSEA) with intermittent epidural bolus (IEB, 10ml bolused every 60 minutes) 4 Intermittent epidural bolus Epidural analgesia (EA) with intermittent epidural bolus (IEB, 5ml bolused every 30 minutes)
- Primary Outcome Measures
Name Time Method Maternal oral and tympanic temperature At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours)
- Secondary Outcome Measures
Name Time Method Maternal serum tumor necrosis factor-α At time of placental delivery and 3, 6 and 12 hours later Cord serum tumor necrosis factor-α At time of placental delivery Maternal serum Interleukin-1β At time of placental delivery and 3, 6 and 12 hours later Cord serum Interleukin-1β At time of placental delivery Maternal serum Interleukin-6 At time of placental delivery and 3, 6 and 12 hours later Cord serum Interleukin-6 At time of placental delivery Maternal serum Interleukin-10 At time of placental delivery and 3, 6 and 12 hours later Cord serum Interleukin-10 At time of placental delivery Regression and correlation analyses between maternal and cord serum cytokines At twelve hours postpartum Placental routine pathologic examination At time of placental delivery Maternal and cord blood gase analysis At time of placental delivery Maternal modified Bromage scale and visual analogue scale At time of initiation of analgesia and hourly thereafter until 2 hours postpartum (approximately 10 hours) Rescue boluses, n of rescue boluses, and the consumption of the ropivacaine/sufentanil mixture At two hours postpartum Rates of cesarean delivery and instrument-assisted delivery At time of placental delivery Indications of cesarean delivery Initiation of analgesia to placental delivery (approximately 8 hours) Duration of analgesia Initiation of analgesia to 2 h postpartum (approximately 10 hours) Durations of labor stages From the beginning of regular contraction of uterus to the end of the labor (approximately 12 hours) Maternal satisfaction with analgesia At two hours postpartum Neonatal antibiotic treatment One week after baby was born Maternal heart rate, respiratory rate, and blood pressure At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours) Low back pain at 3 months after vaginal delivery At the third month after vaginal delivery Breastfeeding success at 6 weeks after vaginal delivery At the sixth week after successful delivery Maternal group B streptococcus (GBS) colonization At time of initiation of analgesia 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) Neonatal weight At delivery 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) 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) Maternal postpartum depression At time of delivery and daily thereafter until 1 year postpartum (approximately 1 year) Neonatal Apgar scale At the first and fifth minutes after baby was born Highest thoracic sensory level to alcohol At three hours after initiation of analgesia Uterine contraction At time of initiation of analgesia and hourly thereafter until 4 hours postpartum (approximately 12 hours) Neonatal rectal temperature At delivery, 30 min after delivery, and 1 h after delivery Use of oxytocin after analgesia At twenty-four hours postpartum Incidence of maternal side effects Initiation of analgesia to 2 hour postpartum (approximately 10 hours) Neonatal Neurologic and Adaptive Capacity Score At 30 min, 2 h, and 24 h after baby was born Maximal oxytocin dose At twenty-four hours postpartum Neonatal sepsis evaluation At 30 min after baby was born Fetal heart rate From initiation of analgesia to delivery (approximately 8 hours)
Trial Locations
- Locations (1)
Nanjing Maternal and Child Health Care Hospital Affiliated to Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China