Patient Controlled Remifentanil Analgesia for Normal Labour

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

Detailed Description
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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

Official Title
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Patient Controlled Remifentanil Analgesia vs. Epidural Analgesia for Normal Labour. A Prospective Randomised Study

Conditions
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Labor Pain, Full Term Pregnancy

Intervention / Treatment
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* Drug: Patient-controlled remifentanil analgesia
* Drug: Epidural analgesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient-controlled remifentanil analgesia<br>Patients will received Patient-controlled remifentanil analgesia starting from labour pain until delivery | Drug: Patient-controlled remifentanil analgesia<br>* Patient controlled remifentanil analgesia with a regimen to provide a bolus of 40 μg remifentanil with a lockout interval of 2 min<br>|
| Placebo Comparator: Epidural analgesia<br>Patients will received continuous epidural analgesia starting from labour pain until delivery | Drug: Epidural analgesia<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall patient's satisfaction | As being assesses using 100-mm visual analog score (0: unsatisfied, 100: very satisfied) | For 24 hours after labour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Visual Analog Score at rest | As being assesses using 10-cm visual analog score (0: no pain, 10: very agonising pain) | 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) | For 24 hours after the start of labour pain | 
| Maternal nausea and vomiting | (0: no nausea or vomiting, 1: severe nausea, 3: vomiting) | For 24 hours after the start of labour pain | 
| Maternal respiratory depression | If respiratory rate decreases less than 10/min | For 24 hours after the start of labour pain | 
| Neonatal Apgar score at 1 min | Assessed using 5-points Apgar score | For 5 min after birth | 
| Neonatal Apgar score at 5 min | Assessed using 5-points Apgar score | For 5 min after birth | 
| Neonatal blood PaO2 | PaO2 value | For 5 min after birth | 
| Neonatal blood PaCO2 | PaCO2 value | For 5 min after birth | 
| Neonatal blood pH | pH value | For 5 min after birth |