DEXMEDETOMIDINE in NORMAL VAGINAL DELIVERY

Study Overview
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Brief Summary
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compare the effect of intravenous and epidural dexmetomidine as an adjuvant to local anesthetics in epidural labor analgesia in normal labor

Official Title
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INTRAVENOUS Versus EPIDURAL DEXMEDETOMIDINE for ANALGESIA in NORMAL VAGINAL DELIVERY: A RANDOMIZED CONTROLED STUDY

Conditions
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Painless Vainal Labour

Intervention / Treatment
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* Drug: Dexmedetomidine Injection [Precedex]
* Drug: Bupivacaine Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Full term (≥ 37 weeks) healthy primigravida parturients ASA2 with single fetus scheduled for vaginal delivery with cephalic presentation requesting labor analgesia. Exclusion Criteria: Allergy to dexmetomidine.(based on previous history) Cardiac conduction abnormalities.(all degrees of heart block , tachyarrythmias) Twins. Malpresentation. Preeclampsia or gestational hypertension Uncontrolled diabetes HBA1c ≥ 6.5% Uncontrolled renal failure Uncontrolled liver disease Bleeding tendency or coagulopathy. Contraindication or patient refusal to epidural block. Body mass index ≥ 35.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 30 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: plan group<br>bupivacaine will be administered epidurally as a loading dose then epidural continuous infusion with 0.125 % bupivacaine at rate 10 ml will be a maintainance for analgesia .IV placebo (normal saline) infusion will be connected to each patient at a rate of 10 ml \hr. | Drug: Bupivacaine Injection<br>* intervention drug will be administred epidurally<br>|
| Active Comparator: epidural group<br>10 ml of 0.125 % buoivacaine with 0.5 µg\ml dexmetomidine as a loading dose then continuous epidural infusion of 0.125% bupivacaine with 0.5µ/ml dexmetomidine at a rate of 10 ml\hr will be used as maintainance . IV placebo (normal saline) infusion will be connected to each patient at a rate of 10 ml\hr | Drug: Dexmedetomidine Injection [Precedex]<br>* interventional drug will be administred either intravenously or epidurally<br>Drug: Bupivacaine Injection<br>* intervention drug will be administred epidurally<br>|
| Active Comparator: intravenous group<br>continuous intravenous dexmetomidine infusion at rate of 0.5 µg / kg / hour in addition to same epidural infusion of 0.125% bupivacaine | Drug: Dexmedetomidine Injection [Precedex]<br>* interventional drug will be administred either intravenously or epidurally<br>Drug: Bupivacaine Injection<br>* intervention drug will be administred epidurally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain relief | VAS score from 0 to 10 will be assesed | at 30 min after induction of block | 
| pain relief | VAS score from 0 to 10 | on delivery |