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Completed

NCT Number: NCT02809742

Intermittent Ropivacaine Bolus for Epidural Labor Analgesia

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)

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

CHU Nimes

Nîmes, Gard, 30000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

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

Other names: ropivacaine 2 mg/ml

Primary outcomes

  1. Verbal Analogue Satisfaction Score

    Time frame: 1 day

    VASS: 0-10: 0 = no satisfaction to 10 (total satisfaction)

Secondary outcomes

  1. maternal hypotension

    Time frame: 1 day

    Evaluation of adverse events over epidural infusion (mean arterial pressure< 65 mmHg)

  2. Apgar score

    Time frame: 1 day

    The 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.

  3. Anesthetic rescue

    Time frame: 1 day

    Evaluation of the rescue performed by anesthesist over infusion

  4. nausea

    Time frame: 1 day

    Number of maternal nausea event

  5. fetal heart rate

    Time frame: 1 day

    Fetal heart sounds were monitored with a continuous Doppler machine

  6. Motor blockade

    Time frame: 1 day

    Bromage score for maternal motor block

Sponsors and collaborators

Lead sponsor

Pierre and Marie Curie University

Other

Registry information

Official study title

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

Acronym: OptimEpi

Important dates

Study start
2016
Primary completion
2016
Study completion
2019
First posted
Jun 22, 2016
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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