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Intermittent Ropivacaine Bolus for Epidural Labor Analgesia

NCT02809742 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2019-07-08

No results posted yet for this study

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)

Conditions

  • Labor Pain

Interventions

DRUG

Ropivacaine

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

Sponsors & Collaborators

  • Pierre and Marie Curie University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-07-31
Completion
2019-07-04

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02809742 on ClinicalTrials.gov