Effectiveness of Programed Intermittent Epidural Bolus Interval 90 (EI90) of 10 ml, 0.0625% Bupivacaine Plus 2 μg/mL Fentanyl interval90(EI90)of10ml,0.0625%Bupivacaine Plus 2μg/mL Fentanyl

Study Overview
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Brief Summary
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Multiple studies showed the numerous advantages of implementing programmed epidural bolus (PIEB) technique, where a fixed volume of local anesthetic is automatically administrated at a set time interval compared to the continuous epidural infusion technique (CEI). The advantages were improved maternal satisfaction, decreased local anesthetic consumption, and decreased second stage of labor.The theory behind PIEB is that to attain a more uniform spread of local anesthetic in the epidural space a higher volume of injectate and a higher pressure is needed.Different approaches using different timings and volumes for PIEB have been proposed to achieve the optimal regimen. Many studies showed evidence that 10 mL boluses of bupivacaine 0.0625% with fentanyl 2 μg/mL delivered every 40 min, named effective programed intermittent epidural bolus interval 90 (EI90), produced effective analgesia without breakthrough pain in 90% of nulliparous women during the first stage of labor.

Official Title
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Comparison Study of Effective Programed Intermittent Epidural Bolus Interval 90 (EI90) of 10ml,0.0625% Bupivacaine Plus 2μg/mL Fentanyl in Nulliparous Versus Multiparous Parturient

Conditions
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Labour Pain

Intervention / Treatment
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* Device: programed intermittent epidural bolus interval 90 (EI90)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of ASA physical status 2-3 with a singleton pregnancy gestational age > 37 weeks regular uterine contractions occurring at least every 5 min; cervical dilation 2-5 cm pain > 5 (Visual analogue score (VAS) 0-10) at the time of request for epidural analgesia . Exclusion Criteria: Refusal to concent Contraindication to epidural analgesia as allergy or hypersensitivity to bupivacaine or fentanyl Patients who had opioids or sedatives within 4 h preceding epidural insertion. Unintentional dural puncture. Patient who deliver within 1 h after initiation of epidural clinician bolus. The inability to achieve as VAS score ≤2 after the initial loading dose will be considered as a failure and will be excluded from the study.

Ages Eligible for Study
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Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nulliparous<br>Patients of ASA physical status 2-3 with a singleton pregnancy; gestational age > 37 weeks; regular uterine contractions occurring at least every 5 min; cervical dilation 2-5 cm; and pain > 5 | Device: programed intermittent epidural bolus interval 90 (EI90)<br>* programed intermittent epidural bolus interval 90 (EI90) of 10 ml, 0.0625% bupivacaine plus 2 μg/mL fentanyl<br>|
| Active Comparator: Multiparous<br>Patients of ASA physical status 2-3 with a singleton pregnancy; gestational age > 37 weeks; regular uterine contractions occurring at least every 5 min; cervical dilation 2-5 cm; and pain > 5 | Device: programed intermittent epidural bolus interval 90 (EI90)<br>* programed intermittent epidural bolus interval 90 (EI90) of 10 ml, 0.0625% bupivacaine plus 2 μg/mL fentanyl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adequate labour analgesia | Time of first call for bolus dose of epidural After loading dose | six hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper sensory block | Secsensory block level to ice | 24hours | 
| Visual Analogue Scale to pain | As zero is no pain and 10 is the maximum pain that can be felt | 24 hours | 
| Motor block | Motor block measured by bromage scale | 24 hours | 
| Total anaesthetic volume | Total volume of local anesthetic used | 24 hours | 
| Side effects | Presence of side effects as neusea, vomiting,peruritis | 24 hours |