Patient Controlled Remifentanil Analgesia for Normal Labour

Mansoura University

Overview

Patient controlled remifentanil analgesia might offer comparative overall patient satisfaction and improved quality of analgesia after normal labour with continuous epidural analgesia.

We are aiming to study the effects of patient controlled remifentanil analgesia and epidural analgesia for normal labour in full term parturients on: * Peripartum analgesia * Overall patient's satisfaction * Maternal adverse effects * Neonatal outcomes

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Conditions

Labor Pain Full Term Pregnancy

Interventions

Patient-controlled remifentanil analgesiaDRUG

Patient controlled remifentanil analgesia with a regimen to provide a bolus of 40 μg remifentanil with a lockout interval of 2 min

Epidural analgesiaDRUG

Patients will receive continuous epidural analgesia using bupivacaine 0.125% in conjunction with fentanyl 2 ug/ml at a rate of 8-15 ml/hr

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Gestational age \> 36 weeks * American Society of Anesthesiologists physical class I to III Exclusion Criteria: * Allergy to study solution * Contraindications to epidural analgesia * Non consented parturients * Communications barriers. * Intrauterine foetal growth retardation * Foetal distress

Locations (1)

Mansoura University Hospitals

Al Mansurah, DK, Egypt

Outcomes

Primary Outcomes

Overall patient's satisfaction

As being assesses using 100-mm visual analog score (0: unsatisfied, 100: very satisfied)

Time frame: For 24 hours after labour

Secondary Outcomes

Pain Visual Analog Score at rest

As being assesses using 10-cm visual analog score (0: no pain, 10: very agonising pain)

Time frame: For 24 hours after the start of labour pain

Pain Visual Analog Score on movement

As being assesses using 10-cm visual analog score (0: no pain, 10: very agonising pain)

Time frame: For 24 hours after the start of labour pain

Maternal nausea and vomiting

(0: no nausea or vomiting, 1: severe nausea, 3: vomiting)

Time frame: For 24 hours after the start of labour pain

Maternal respiratory depression

If respiratory rate decreases less than 10/min

Time frame: For 24 hours after the start of labour pain

Neonatal Apgar score at 1 min

Assessed using 5-points Apgar score

Time frame: For 5 min after birth

Neonatal Apgar score at 5 min

Assessed using 5-points Apgar score

Time frame: For 5 min after birth

Neonatal blood PaO2

PaO2 value

Time frame: For 5 min after birth

Data from ClinicalTrials.gov

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