Intermittent Ropivacaine Bolus for Epidural Labor Analgesia

NCT02809742 | Completed DMC

• 1 other identifier: PMCurrieU2
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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)

Conditions

Labor Pain

Keywords

Pregnant; Labor; Epidural; Analgesia; Intermittent

Outcome Measures

Primary Outcomes (1)

• Verbal Analogue Satisfaction Score

  VASS: 0-10: 0 = no satisfaction to 10 (total satisfaction)

  1 day

Secondary Outcomes (6)

• maternal hypotension

  1 day

• Apgar score

  1 day

• Anesthetic rescue

  1 day

• nausea

  1 day

• fetal heart rate

  1 day

Study Arms (1)

Epidural group

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

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

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

Also known as: ropivacaine 2 mg/ml

Epidural group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• Hypertension
• no vertex presentation
• contraindications to neuraxial blockade

Sponsors & Collaborators

• Pierre and Marie Curie University: lead

Study Sites (1)

CHU Nimes

Nîmes, Gard, 30000, France

Location

MeSH Terms

Conditions

Labor Pain; Agnosia

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 22, 2016
• Study Start: May 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: July 4, 2019
• Last Updated: July 8, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)