Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor

Study Overview
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Brief Summary
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Central neuraxial analgesia has been extensively used for labor analgesia and is currently the gold standard technique for pain control in obstetrics. The aim of the study will be to compare the role of dexmedetomidine or fentanyl as additives to epidural levobupivacaine in painless vaginal delivery as regard maternal analgesia and safety.

Official Title
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Role of Dexmedetomidine or Fentanyl as Additives to Epidural Levobupivacaine in Painless Labor: A Double Blind Randomized Controlled Study

Conditions
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Epidural Analgesia, Painless Labor, Dexmedetomidine, Fentanyl, Levobupivacaine

Intervention / Treatment
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* Drug: levobupivacaine
* Drug: Dexmedetomidine
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status class II and III, Full term pregnancy. Exclusion Criteria: Patient refusal to epidural analgesia, Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity hypersensitivity to levobupivacaine, dexmedetomidine or fentanyl, hemodynamic instability, severe aortic or mitral stenosis), Cardiac diseases Severe pre-eclampsia, Breech presentations Antepartum hemorrhage Cephalopelvic disproportion Body mass index ≥40 kg/m2.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 41 Years

Sexes Eligible for Study
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All

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomly allocated into three equal groups by computer generated sequence through sealed opaque envelopes. Each group will include 30 patients. Group C (Control group): Epidural analgesia with levobupivacaine alone Group D (Dexmedetomidine group): Epidural analgesia with levobupivacaine and dexmedetomidine Group F (Fentanyl group): Epidural analgesia with levobupivacaine and fentanyl
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group C (Control group)<br>pidural analgesia with levobupivacaine alone | Drug: levobupivacaine<br>* The patients will receive 15 ml of 0.125% levobupivacaine.<br>|
| Experimental: Group D (Dexmedetomidine group)<br>Epidural analgesia with levobupivacaine and dexmedetomidine | Drug: levobupivacaine<br>* The patients will receive 15 ml of 0.125% levobupivacaine.<br>Drug: Dexmedetomidine<br>* The patients will receive 13 ml of 0.125% levobupivacaine and 0.5μg/kg dexmedetomidine diluted in 2 ml saline.<br>|
| Experimental: Group F (Fentanyl group)<br>Epidural analgesia with levobupivacaine and fentanyl | Drug: levobupivacaine<br>* The patients will receive 15 ml of 0.125% levobupivacaine.<br>Drug: Fentanyl<br>* The patients will receive 13 ml of 0.125% levobupivacaine and 25μg fentanyl diluted in 2 ml saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of maternal analgesia | Duration of analgesia will be assessed by measuring the time between the onset of sensory block and return of pain sensation. If the block is inadequate or the patient has pain, a top up dose of 8 mL of the study medication and local anesthetic will be given when visual analogue scale (VAS) will be ≥ 4. The pain relief will be assessed by the visual analogue scale (VAS) from 0 to 10 (0: no pain, 1-3: mild pain, 4-7: moderate pain, > 7: severe pain). | 24 hours after epidural injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of maternal analgesia. | The onset of analgesia will be defined as the time taken from drug administration to visual analogue scale (VAS) <3. | One hour after epidural injection | 
| Complications of drugs of epidural technique | Drugs: Sedation, Bradycardia Epidural anesthesia (including nausea, vomiting, backache and fever) | 24 hours after epidural injection |