Clinical trial NCT02809742: Intermittent Ropivacaine Bolus for Epidural Labor Analgesia
Official title: Intermittent Bolus Administration of Ropivacaine for Epidural Labor Analgesia : an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labor Pain
Keywords: Pregnant
Labor
Epidural
Analgesia
Intermittent
Lead sponsor: Pierre and Marie Curie University
Sponsor class: OTHER
First posted: 2016-06-22
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: Verbal Analogue Satisfaction Score
timeFrame: 1 day
Secondary outcomes:
measure: maternal hypotension
timeFrame: 1 day
measure: Apgar score
timeFrame: 1 day
measure: Anesthetic rescue
timeFrame: 1 day
measure: nausea
timeFrame: 1 day
measure: fetal heart rate
timeFrame: 1 day
measure: Motor blockade
timeFrame: 1 day
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU Nimes
state: Gard
Study officials:
References: