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Intermittent Ropivacaine Bolus for Epidural Labor Analgesia

Intermittent Bolus Administration of Ropivacaine for Epidural Labor Analgesia : an Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02809742
Acronym
OptimEpi
Enrollment
500
Registered
2016-06-22
Start date
2016-05-31
Completion date
2019-07-04
Last updated
2019-07-08

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

Conditions

Labor Pain

Keywords

Pregnant, Labor, Epidural, Analgesia, Intermittent

Brief summary

Enhanced patient safety and satisfaction have contributed to growing use of epidural labor analgesia. Epidural analgesia appears to be currently the most effective technique in reducing pain during labor. However, reduction in total dose of local anesthetic and thus motor blockade is crucial to improve the obstetric outcome. This technique has evolved from intermittent boluses by anesthesiologists to the current standard labor epidural analgesic regimens in many institutions in North America and Europe that consist of a local anesthetic in combination with an opioid delivered via continuous epidural infusion (CEI) with or without patient-controlled epidural analgesia (PCEA) boluses. Recently,a new mode of administration has been used: regular bolus of low concentration local anesthetic + intermittent bolus (PIEB). This technique would offer safe and superior quality labor analgesia and greater maternal satisfaction by reducing total amount of the drug combination. The primary outcome was to evaluate the analgesic efficacy of PIEB epidural drug delivery in terms of visual analogue scale satisfaction (VAS) score in a large cohort of patients. The secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric outcomes, total drug dose and incidence of pain that required top-up administration (breakthrough pain)

Detailed description

Patients were explained about the procedure and written informed consent was obtained. Healthy term primi or second gravid parturients (aged \>18 years) with a singleton, live fetus in vertex presentation when in active stage of labor with cervical dilation of 3-5 cm were recruited in the study after they requested epidural for pain relief. PIEB epidural analgesia was used. Primary outcome was maternal satisfaction during labor and delivery. Our hypothesis was that patients would have a greater level of satisfaction when using PIEB technique. The secondary outcomes were to measure the degree of motor blockade, neonatal and obstetric outcomes.

Interventions

DRUGRopivacaine

Epidural : automatic intermittent boluses associated with patient controlled bolus using ropivacaine

Sponsors

Pierre and Marie Curie University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* healthy term primi or second gravid parturients * aged 18-30 years * singleton, live fetus * vertex presentation * active stage of labor with cervical dilation of 3-5 cm parturients

Exclusion criteria

* Hypertension * no vertex presentation * contraindications to neuraxial blockade

Design outcomes

Primary

MeasureTime frameDescription
Verbal Analogue Satisfaction Score1 dayVASS: 0-10: 0 = no satisfaction to 10 (total satisfaction)

Secondary

MeasureTime frameDescription
Apgar score1 dayThe Apgar test is done by a doctor, midwife, or nurse. The health care provider examines the baby's: * Breathing effort * Heart rate * Muscle tone * Reflexes * Skin color Each category is scored with 0, 1, or 2, depending on the observed condition.
Anesthetic rescue1 dayEvaluation of the rescue performed by anesthesist over infusion
maternal hypotension1 dayEvaluation of adverse events over epidural infusion (mean arterial pressure\< 65 mmHg)
fetal heart rate1 dayFetal heart sounds were monitored with a continuous Doppler machine
Motor blockade1 dayBromage score for maternal motor block
nausea1 dayNumber of maternal nausea event

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026