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Comparing of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia

Comparing of programmed intermittent epidural bolus (PIEB) with continuous epidural infusion (CEI) for labor analgesia in patients receiving epidural dexmedetomidine and Rupivacaine

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210405050851N1
Enrollment
60
Registered
2021-10-30
Start date
2021-11-06
Completion date
Unknown
Last updated
2021-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidural labor analgesia. Other complications of spinal and epidural anesthesia during labor and delivery

Interventions

Intervention 1: Intervention group 1: Term women with gestational age 37 weeks or more who have entrance condition to the study, amount of 3cc test dose of Dexmedetomidine 0.5µg/ml and Rupivacain %0.1

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Term woman with gestational age 37 weeks or more Cervical dilation Larger than 4 cm Spontaneous or induced labor pain Applying for epidural analgesia Weight 55 to 85 kg

Exclusion criteria

Exclusion criteria: Patients with past medical history of sever cardiovascular diseases and bradycardia Contraindication of epidural analgesia Patients that are candidate for cesarean section ( multiple pregnancy , gestational age more than 37 weeks, preeclampsia , etc ) Patient discontent Opium addiction Height less than 150 cm

Design outcomes

Primary

MeasureTime frame
Maternal satisfaction of labor analgesia. Timepoint: At the end of labor. Method of measurement: Visual analogue scale.;Total dose of Dexmedetomidine using in the end of labor. Timepoint: At the end of labor. Method of measurement: Based on checklist - in milliliters.;Total dose of Rupivacain using in the end of labor. Timepoint: At the end of labor. Method of measurement: Based on checklist - in milliliters.

Secondary

MeasureTime frame
New born Infant Apgar score. Timepoint: In the first and fifth minute after fetal delivery. Method of measurement: Apgar score.;Infant Arterial Blood Gas. Timepoint: Five minutes after fetal delivery. Method of measurement: Umbilical cord arterial blood.;Incidence rate of instrumental delivery. Timepoint: The last stage of delivery. Method of measurement: Record in the end of labor.;Duration of delivery. Timepoint: Duration of delivery from the time of patient entrance in the labor until the time of fetal delivery. Method of measurement: Based on checklist - minute unit.;Side effects including nausea, vomiting, itching, decrease blood pressure, bradycardia. Timepoint: From the loading dose of epidural analgesia every hour till the end of labor. Method of measurement: Patient's sign and symptoms and record in the checklist.;Incidence rate of motor block. Timepoint: From the beginning of Epidural analgesia every hour till the end of labor. Method of measurement: Bromage score (0- 1- 2- 3).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactGolnoosh Khosravian

Iran University of Medical Sciences

desdemona_wsh@yahoo.com+98 21 2243 4717

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026