Intermittent Ropivacaine Bolus for Epidural Labor Analgesia

Labor Pain Clinical Trial

— OptimEpi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02809742
• Other study ID #: PMCurrieU2
• Status: Completed
• Start date: May 2016
• Est. completion date: July 4, 2019

Study information

• Verified date: July 2019
• Source: Pierre and Marie Curie University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 4, 2019
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

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

Locations

Country	Name	City	State
France	CHU Nimes	Nimes	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Pierre and Marie Curie University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Verbal Analogue Satisfaction Score	VASS: 0-10: 0 = no satisfaction to 10 (total satisfaction)	1 day
Secondary	maternal hypotension	Evaluation of adverse events over epidural infusion (mean arterial pressure< 65 mmHg)	1 day
Secondary	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
Secondary	Anesthetic rescue	Evaluation of the rescue performed by anesthesist over infusion	1 day
Secondary	nausea	Number of maternal nausea event	1 day
Secondary	fetal heart rate	Fetal heart sounds were monitored with a continuous Doppler machine	1 day
Secondary	Motor blockade	Bromage score for maternal motor block	1 day