Intermittent Ropivacaine Bolus for Epidural Labor Analgesia (OptimEpi)

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

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)

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Drug: Ropivacaine

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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• France
  • Gard
    • Nimes, Gard, France, 30000
      • CHU Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Epidural group; Epidural : automatic intermittent boluses ( 8-12 mL per hour) + patient controlled bolus (4 mL evrey 20 min) using ropivacaine	Drug: Ropivacaine; Epidural : automatic intermittent boluses associated with patient controlled bolus using ropivacaine; Other Names: ropivacaine 2 mg/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verbal Analogue Satisfaction Score	VASS: 0-10: 0 = no satisfaction to 10 (total satisfaction)	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maternal hypotension	Evaluation of adverse events over epidural infusion (mean arterial pressure< 65 mmHg)	1 day
Apgar score	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.	1 day
Anesthetic rescue	Evaluation of the rescue performed by anesthesist over infusion	1 day
nausea	Number of maternal nausea event	1 day
fetal heart rate	Fetal heart sounds were monitored with a continuous Doppler machine	1 day
Motor blockade	Bromage score for maternal motor block	1 day

Collaborators and Investigators

• Sponsor: Pierre and Marie Curie University

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (ACTUAL): July 1, 2016
• Study Completion (ACTUAL): July 4, 2019

Study Registration Dates

• First Submitted: May 31, 2016
• First Submitted That Met QC Criteria: June 18, 2016
• First Posted (ESTIMATE): June 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): July 8, 2019
• Last Update Submitted That Met QC Criteria: July 4, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Analgesia; Epidural; Labor; Pregnant; Intermittent
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: PMCurrieU2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO