Epidural Dexmedetomidine vs Nalbuphine for Labor Analgesia

Study Overview
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Brief Summary
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The aim of this study is to compare epidural dexmedetomidine vs nalbuphine added to bupivacaine in labor analgesia and determine the privilege of one over the other and to compare the effect of both analgesics after delivery.

Detailed Description
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Labor pain often causes a strong stress response in women. Recently, it is concerned by most mothers and doctors that how to effectively alleviate the pain during delivery. There is no standard treatment for labor pain. A wide range of pharmacological and non-pharmacological labor pain relief techniques are available for pregnant women . Labor analgesia, also known as painless childbirth, refers to the use of various methods to reduce maternal labor pain or make it disappear. The ideal labor analgesia should be based on maternal and child safety, and should have fast acting, good analgesic effect and less adverse reaction. Epidural block anesthesia is convenient, and has less adverse reaction and obvious effect in the commonly used analgesic methods, which is widely used in the current way of analgesia. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist that has sedative, hypnotic, and analgesic effects . Nalbuphine is a synthetic agonist antagoLabor pain often causes a strong stress response in women. Recently, it is concerned by most mothers and doctors that how to effectively alleviate the pain during delivery. There is no standard treatment for labor pain. A wide range of pharmacological and non-pharmacological labor pain relief techniques are available for pregnant women . Labor analgesia, also known as painless childbirth, refers to the use of various methods to reduce maternal labor pain or make it disappear. The ideal labor analgesia should be based on maternal and child safety, and should have fast acting, good analgesic effect and less adverse reaction. Epidural block anesthesia is convenient, and has less adverse reaction and obvious effect in the commonly used analgesic methods, which is widely used in the current way of analgesia. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist that has sedative, hypnotic, and analgesic effects . Nalbuphine is a synthetic agonist antagonist opioid that has the characteristics of mu-antagonist and kappa-agonist activities. Nalbuphine has gained popularity as a parenteral analgesic for intraoperative, postoperative, and obstetrical uses . The purpose of this study is to compare between the 2 drugs in decreasing labor pain. st opioid that has the characteristics of mu-antagonist and kappa-agonist activities. Nalbuphine has gained popularity as a parenteral analgesic for intraoperative, postoperative, and obstetrical uses . The purpose of this study is to compare between the 2 drugs in decreasing labor pain.

Official Title
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Effect of Epidural Dexmedetomidine VS Nalbuphine for Labor Analgesia

Conditions
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Epidural Anesthesia, Labor Pain

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Nalbuphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the parturients should : Be between 21 - 40 years old ASA classification I- II Para 1-2 Requesting analgesia Have a normal birth canal Be at the beginning of active phase of labor i.e. cervical dilatation of 4 cm with regular uterine contractions. The fetus should be a single full-term fetus (37- 42 weeks of gestation) with normal head position, normal development. Exclusion Criteria: Parturients Younger than 21 and older than 40 years old With contraindication of regional anesthesia With pre-existing neurological disease With history of allergy to the study drugs With cephalopelvic disproportion, fetal distress, amniotic fluid infection, placental insufficiency or scarred uterus

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (Dexmedetomidine group)<br>a bolus dose of 11ml of 0.25% bupivacaine + 0.5μg/ml preservative free dexmedetomidine (1ml volume) will be injected via the epidural catheter. For top up 5 ml of 0.25% bupivacaine + 0.5μg/ml dexmedetomidine (1ml volume) will be given when VAS score becomes 4 or more. | Drug: Dexmedetomidine<br>* Dexmedetomidine, a highly selective α₂ receptor agonist, has a sympatholytic, sedative and opioid sparing effect.<br>* Other names: Precedex;|
| Active Comparator: Group B (Nalbuphine group)<br>a bolus dose of 11ml of 0.25% bupivacaine + 10mg preservative free nalbuphine (1ml volume) will be injected via the epidural catheter. For top up 5 ml of 0.25% bupivacaine + 2mg nalbuphine (1ml volume) will be given when VAS score becomes 4 or more. | Drug: Nalbuphine<br>* Nalbuphine, a derivative of 14-hydroxymorphine is a strong analgesic with mixed k agonist and µ antagonist properties. The analgesic potency of nalbuphine has been found to be equal to morphine<br>* Other names: Nalufin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in VAS score for pain before analgesia and every 30 minutes after analgesia | The visual analog scale (VAS) is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity along a 100 mm (10 cm) horizontal line, and this rating is then measured from the left edge (=VAS score). The VAS score correlates well with acute pain levels (Myles et al., 1999). Using a ruler, the score is determined by measuring the distance (cm) on the 10-cm line between the no pain anchor and the patients mark, providing a range of scores from 010. A higher score indicates greater pain intensity. | before analgesia and 30 minutes after analgesia and then every 30 minute as long as the epidural catheter is inserted (up to 360 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Heart rate before analgesia and every 30 minutes after analgesia | Monitored and recorded | before analgesia and 30 minutes after analgesia and then every 30 minute as long as the epidural catheter is inserted (up to 360 minutes) | 
| change in arterial blood pressure before analgesia and every 30 minutes after analgesia | Monitored and recorded | before analgesia and 30 minutes after analgesia and then every 30 minute as long as the epidural catheter is inserted (up to 360 minutes) | 
| change in SpO2 before analgesia and every 30 minutes after analgesia | Monitored and recorded | before analgesia and 30 minutes after analgesia and then every 30 minute as long as the epidural catheter is inserted (up to 360 minutes) | 
| Duration of active phase of 1st stage of labor | The duration of active phase of 1st stage of labor varies from one to the other | from 100 minutes to 300 minutes | 
| Duration of 2nd stage of labor | The duration of 2nd stage of labor varies from one to the other | from 30 minutes to 200 minutes | 
| Duration of 3rd stage of labor | The duration of 3rd stage of labor varies from one to the other | from 5 minutes to 15 minutes | 
| Neonatal condition: APGAR score at 1 and 5 min after the birth | to check if any of the study drugs can deteriorate the neonatal condition | At 1 minute and 5 minutes after birth | 
| The adverse reactions: itching, nausea, vomiting, bradycardia and hypotension | These adverse reaction can occur after administration of the interventional drugs | As long as the epidural catheter is inserted (up to 360 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Nalbuphine