Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine

Study Overview
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Brief Summary
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Spinal anesthesia is the most consistent block for lower abdomen and lower limb surgical procedures. Over years many drugs have been used as an additive to spinal anesthesia in order to prolong the duration of action and to provide adequate postoperative analgesia. Dexmedetomidine, a highly selective α2 agonist is rapidly emerging as the choice of additive to spinal anesthesia in view of its property to provide analgesia however, it may be associated with bradycardia which may affect the hemodynamic stability. Nalbuphine is an opioid with agonist actions in the kappa receptor and antagonist actions in the mu receptor, it produces analgesia and sedation and lesser side effects through antagonism at the mu receptor but, it could be associated with some side effects as: dizziness, bradycardia, nausea, vomiting, and pruritus and may be associated with respiratory depression.

Detailed Description
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This prospective, double blinded, randomized, controlled study will be held to compare Nalbuphine versus Dexmedetomidine as adjuvants to intrathecal Bupivacaine in spinal anesthesia in patients undergoing lower limb orthopedic surgeries

Official Title
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Dexmedetomidine Versus Nalbuphine as an Adjuvant to Intrathecal Bupivacaine in Lower Limb Surgeries

Conditions
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Analgesia

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: Nalbuphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20 and 60 years. Both genders. Patients scheduled for lower limb orthopedic surgeries under spinal anesthesia. American society of anesthesiologists (ASA) class I or II. Exclusion Criteria: Patient refusal. Age <20 or >60 years. Contraindications to spinal anesthesia (e.g. bleeding diathesis, spinal cord deformities, infection at injection site). History of allergy to any of the study medications. Cases with severe cardiac, renal, or hepatic disease. American society of anesthesiologists (ASA) class III, IV. Patient on regular analgesics or opioid abuse. Patient with peripheral neuropathy.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Via the sealed envelope method; the patients will be randomly assigned to three equal groups according to the administration of adjuvant to intrathecal Bupivacaine and its dose; Bupivacaine group (B gp) will include patients who will receive 2.5 ml hyperbaric bupivacaine (0.5%) +0.5 ml normal saline. Bupivacaine-Dexmedetomidine group (BDgp) will include patients who will receive 2.5 ml hyperbaric bupivacaine (0.5%) plus Dexmedetomidine (10 µg in 0.5 ml normal saline). Bupivacaine-Nalbuphine group (BN gp) will include patients who will receive 2.5 ml hyperbaric bupivacaine (0.5%) plus Nalbuphine (1 mg in 0.5ml normal saline).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Bupivacaine group (B gp)<br>Patients will receive 2.5 ml hyperbaric bupivacaine (0.5%) plus 0.5 ml normal saline | |
| Active Comparator: Bupivacaine-Dexmedetomidine group (BD gp)<br>Patients will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus 10 µg Dexmedetomidine in 0.5 mL normal saline | Drug: Dexmedetomidine<br>* patients who will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus Dexmedetomidine (10 µg in 0.5 mL normal saline)<br>|
| Active Comparator: Bupivacaine-Nalbuphine group (BN gp)<br>Patients will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus 1 mg Nalbuphine in 0.5 mL normal saline | Drug: Nalbuphine<br>* patients who will receive 2.5 mL hyperbaric bupivacaine (0.5%) plus Nalbuphine (1 mg in 0.5 mL normal saline)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The post-operative analgesic duration |  | during the first 24 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of sensory block | from intrathecal injection till sensory block grade 2 at T10 | After intrathecal injection up to 15 minutes | 
| Onset of motor block | from intrathecal injection till reach Bromage scale 3 | After intrathecal injection up to 15 minutes | 
| Heart rate (HR) | beat per minute | Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery | 
| Mean arterial pressure (MAP) | mmHg | Every 5 minutes after spinal injection for the first 30 minutes, and then every 15 minutes till the end of surgery | 
| Hypotension will be considered if there was 25% decrease below the baseline for Mean arterial pressure (MAP) | mmHg | every 5 minutes after spinal injection for the first 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes for the first 6 hours postoperatively | 
| Bradycardia will be considered if the heart rate is less than 50 beats/min | beat per minute | every 5 minutes after spinal injection for the first 30 minutes, then every 15 minutes till the end of surgery and every 30 minutes for the first 6 hours postoperatively | 
| postoperative pain | visual analogue scale (VAS) marked from 0-10 (where 0 = no pain and 10 = worst pain imaginable) | at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively | 
| side effects as Vomiting, Nausea, pruritus, shivering | incidence | Intraoperatively and for the first 24 hours postoperatively | 
| sedation | via Ramsay scale [1= Patient is anxious and agitated or restless, or both, 2= Patient is co-operative, oriented, and tranquil, 3= Patient responds to commands only, 4= Patient exhibits brisk response to light glabellar tap or loud auditory stimulus, 5= Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus and 6=Patient exhibits no response] | at 0, 2, 4, 6, 8,12,18 and 24 hours postoperatively |