Intermittent Ropivacaine Bolus for Epidural Labor Analgesia

NCT ID: NCT02809742

Last Updated: 2019-07-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2019-07-04

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.

Conditions

Labor Pain

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Epidural group

Epidural : automatic intermittent boluses ( 8-12 mL per hour) + patient controlled bolus (4 mL evrey 20 min) using ropivacaine

Ropivacaine

Intervention Type: DRUG

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

Interventions

Ropivacaine

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

Intervention Type: DRUG

Other Intervention Names

ropivacaine 2 mg/ml

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Pierre and Marie Curie University

OTHER

Sponsor Role: lead

Responsible Party

Philippe Cuvillon

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHU Nimes

Nîmes, Gard, France

Countries

France

Other Identifiers

PMCurrieU2

Identifier Type: -

Identifier Source: org_study_id