A Comparison Study of Patient Controlled Epidural Analgesia (PCEA) With and Without Basal Infusion Using Ropivacaine 0,15% and Fentanyl μg/ml for Pain Relief in Labor, Assessment of Efficacy and Maternal Satisfaction.

NCT02084589 | Completed

• 1 other identifier: 101
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, double blind study, in which a comparison of patient controlled epidural analgesia (PCEA) of continuous background infusion with demand dose and demand only, using ropivacaine 0,15% and fentanyl 2μg/ml for pain relief in labor, is being investigated. The purpose of the study is the assessment of the efficacy of labor analgesia and maternal satisfaction. Written informed consent is obtained by all parturients. Non invasive monitor of blood pressure, heart rate, SpO2, ECG for the patient and a continuous monitoring of the fetal heart rate is being placed. The participants are randomized in two groups, both receiving the same drug (ropivacaine 0,15% and fentanyl 2μg/ml). Group 0 receives demand dose of 5 ml with lockout of 10 minutes. Group 1 receives background infusion of 5 ml/h and demand dose of 5 ml with lockout 10 minutes. All parturients have to be instructed to self administration of epidural bolus dose when they experience mild to moderate pain. Both parturient and anesthetist who conducts the study and treat breakthrough pain, are blind to group assignment. After the last suture, total volume of epidural infusions of PCEA, total infused drug of PCEA pump, number of delivered PCEA boluses and manual rescue doses are being calculated. Time of delivery, mode of delivery, Apgar scores, and overall maternal satisfaction scores, neonate pH and Hct of the patient (ABGS), as well as possible need of newborn cardiopulmonary resuscitation are also recorded.

Conditions

Labor Pain

Keywords

PCEA, labor analgesia, background infusion, ropivacaine

Outcome Measures

Primary Outcomes (1)

• The primary outcome is the total volume of epidural local anaesthetic (LA) administrated during labor.

  Approximately 30 min (time of preloading) before the initiation of the epidural technique to 24 h after removal of the epidural catheter.

Study Arms (2)

PCEA of continuous background infusion with demand dose

ACTIVE COMPARATOR

PCEA with background infusion of 5 ml/h and demand dose of 5 ml with lockout 10 minutes, using ropivacaine 0,15% and fentanyl 2μg/ml.

Other: PCEA with basal infusion and demand dose using ropivacaine 0,15% and fentanyl 2μg/ml for pain relief in labor

PCEA with demand dose only

ACTIVE COMPARATOR

PCEA with demand dose of 5 ml with lockout 10 minutes, using ropivacaine 0,15% and fentanyl 2μg/ml.

Other: PCEA without basal infusion (demand only) using ropivacaine 0,15% and fentanyl 2μg/ml for pain relief in labor

Interventions

PCEA with basal infusion and demand dose using ropivacaine 0,15% and fentanyl 2μg/ml for pain relief in labor OTHER

PCEA of continuous background infusion with demand dose

PCEA without basal infusion (demand only) using ropivacaine 0,15% and fentanyl 2μg/ml for pain relief in labor OTHER

PCEA with demand dose only

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 18 and 40 years,
• ASA status I or II,
• Primigravida or secundigravida
• Gestational age \> 38 weeks,
• Cervical dilatation ≥ 4 cm,
• Request for epidural labor analgesia

You may not qualify if:

• Patients refusal to participate to the study
• History of clinical important cardiovascular, pulmonary, hepatic, neurological, psychiatric, metabolic or kidney disease
• Allergy to amino amide class of local anesthetics
• Contraindications to epidural analgesia
• Drug addiction or addiction to alcohol
• Administration of opioids in the last 3 hours before the initiation of labor epidural analgesia
• Use of chronic pain medications

Sponsors & Collaborators

• Paraskevi Matsota: lead

Study Sites (1)

2nd Department of Anesthesiology, Attikon University Hospital

Athens, Attica, 12462, Greece

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Fentanyl; Analgesia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 5, 2014
• First Posted: March 12, 2014
• Study Start: June 1, 2012
• Primary Completion: February 1, 2014
• Last Updated: April 8, 2014

Record last verified: 2014-04

Locations

GR (1)