Analgesic Additives to Epidural Bupivacaine in Normal Labor

Study Overview
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Brief Summary
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The aim of the study will be to compare the role of Dexmedetomidine, Nalbuphine and fentanyl as additives to epidural bupivacaine in painless vaginal delivery as regard of effectiveness analgesia and maternal safety.

Detailed Description
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Labor pain often causes a strong stress response. Several inhalation and parenteral anesthetics, sedatives, tranquilizers, and analgesics have been used for pain relief during labor, while over the last decade, lumbar epidural analgesia has greatly increased . Recently, it was concerned by most mothers and doctors that how to alleviate the pain during delivery. The ideal labor analgesia should be based on maternal and child safety and should have a fast acting good analgesic effect and less adverse reaction . Epidural anesthesia is convenient and has a less adverse reaction and obvious effect in the commonly used analgesic methods, which are widely used in the current way of analgesia . Studies have confirmed the efficacy of dexmedetomidine in prolonging the duration of perineural nerve blocks. Specifically, perineural dexmedetomidine enhances sensory, motor, and analgesic block characteristics. Dexmedetomidine is a selective α₂ receptor agonist and has a sympatholytic, sedative, and opioid sparing effect. It does not cause respiratory depression and can therefore be used as an adjuvant in certain clinical settings . It has also been proved that dexmedetomidine would not increase the risk of side effects, such as nausea, headache, vomiting, shivering, and hypotension . Nalbuphine is a synthetic agonist-antagonist opioid that has the characteristics of Mu-antagonist and Kappa-agonist activities. Nalbuphine has gained parenteral analgesia for intraoperative, postoperative, and obstetrical uses . The analgesic potency of nalbuphine has been found to be equal to morphine, but unlike morphine, it shows a ceiling effect on respiratory depression. It has the potential to provide effective postoperative analgesia with no risk of respiratory depression .

Official Title
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Dexmedetomidine , Fentanyl or Nalbuphine As Additives to Epidural Bupivacaine for Labor Analgesia. A Double Blind Randomized Study.

Conditions
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Labor Pain

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: fentanyl
* Drug: Nalbuphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >/= 18 years of age American Society of Anesthesiologists (ASA) Physical Status 2 or 3 Full term pregnancy (>37 gestational weeks) Planning vaginal delivery Planning epidural labor analgesia Vertex presentation Exclusion Criteria: Patient refusal to epidural analgesia, Contraindications of epidural analgesia (coagulopathy, local infection, vertebral deformity) Allergy to study agents (hypersensitivity to bupivacaine, Nalbuphine, fentanyl or dexmedetomidine) hemodynamic instability, severe aortic or mitral stenosis) Severe pre-eclampsia, Breech presentations Antepartum hemorrhage Cephalopelvic disproportion Body mass index ≥40 kg/m2. Uncontrolled systemic comorbidities [i.e., diabetes, hepatic, renal or cardiac] Known or suspected fetal abnormalities Inability to communicate or participate in study procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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
Interventional Model Description: The participants will be divided into three equal groups ,one group will receive epidural analgesia with bupivacaine and dexmedetomidine, another Group will receive epidural analgesia with bupivacaine and fentanyl and the other Group will receive epidural analgesia with bupivacaine and Nalbuphine.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: epidural Bupivacaine with Dexmedetomidine in normal labor<br>Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with Dexmedetomidine 0.5 μg/ml | Drug: Dexmedetomidine<br>* a group will receive epidural Bupivacaine with Dexmedetomidine in normal labor<br>* Other names: precedex;|
| Active Comparator: epidural Bupivacaine with fentanyl in normal labor<br>Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with fentanyl 2 μg/ml. | Drug: fentanyl<br>* a group will receive epidural Bupivacaine with fentanyl in normal labor<br>* Other names: Durogesic;|
| Active Comparator: epidural Bupivacaine with Nalbuphine in normal labor<br>Epidural analgesia will be initiated and maintained using a solution of 0.125% bupivacaine with 0.2 mg/ml Nalbuphine. | Drug: Nalbuphine<br>* a group will receive epidural Bupivacaine with Nalbuphine in normal labor<br>* Other names: Nalufin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score for pain | changes in VAS score for pain before epidural analgesia, 30 minutes from time 0, at 1 hour and hourly till end of 3rd stage of delivery. | before epidural analgesia, 30 minutes from time 0, at 1 hour and hourly till end of 3rd stage of delivery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural anathesia, normal labor