Dexamethasone Versus Nalbuphine as Adjuvants in Brachial Plexus Block

Study Overview
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Brief Summary
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Brachial plexus block is a very reliable method of regional anesthesia for the upper limb. It achieves ideal operating conditions by producing complete muscular relaxation and stable intraoperative hemodynamics.However,Local anesthetics alone have a shorter duration of postoperative analgesia. Hence,various adjuvants have been added to local anesthetics to achieve quick, dense, and prolonged block. This study assess and compare the efficacy of dexamethasone or nalbuphine as adjuvants to local anesthetics in supraclavicular brachial plexus block for upper limb surgeries.

Detailed Description
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Upper-limb surgeries can be performed under either general or regional anesthesia.However, regional anesthesia has the advantages of long-lasting pain relief & avoidance of airway instrumentation.Brachial plexus block is a very reliable method of regional anesthesia for the upper limb. It achieves ideal operating conditions by producing complete muscular relaxation and stable intraoperative hemodynamics.However,Local anesthetics alone have a shorter duration of postoperative analgesia. Hence,various adjuvants have been added to local anesthetics to achieve quick, dense, and prolonged block. This study assess and compare the efficacy of using 8 mg dexamethasone or 10 mg nalbuphine as adjuvants to local anesthetics mixture (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) in Ultrasound-guided supraclavicular brachial plexus block for upper limb surgeries below the level of the shoulder.

Official Title
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Nalbuphine Versus Dexamethasone as an Adjuvant to Lidocaine / Bupivacaine Mixture in Ultrasound-guided Supraclavicular Brachial Plexus Block for Upper Limb Surgeries

Conditions
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Anesthesia

Intervention / Treatment
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* Procedure: Ultrasound (US) guided supraclavicular brachial plexus block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient acceptance. American Society of Anesthesiologists (ASA) I and (ASA) II. Age 21-60 years old. Both gender. BMI < 30. Accepted mental state of the patient. Unilateral upper limb surgeries below the level of the shoulder. Exclusion Criteria: Patient refusal. Peripheral neuropathy. Pathological coagulopathy. Infection at the injection site. History of active substance abuse. Untreated pneumothorax. Disturbed conscious level. An allergy to local anesthetics or nalbuphine or dexamethasone. Planned for receiving general anesthesia during the same operation for any cause.

Ages Eligible for Study
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Minimum Age: 21 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group I Placebo<br>Ultrasound (US) guided supraclavicular brachial plexus block will be done to the patients who are prepared to undergo upper limb surgeries below the level of the shoulder within the distribution of supraclavicular brachial plexus block using: 30 mL volume of local anesthetics (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) + 2 ml 0.9% normal saline. | Procedure: Ultrasound (US) guided supraclavicular brachial plexus block<br>* Using 8 mg dexamethasone or 10 mg nalbuphine as adjuvants to (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) in ultrasound (US) guided supraclavicular brachial plexus block<br>|
| Active Comparator: Group II Nalbuphine <br>Ultrasound (US) guided supraclavicular brachial plexus block will be done to the patients who are prepared to undergo upper limb surgeries below the level of the shoulder within the distribution of supraclavicular brachial plexus block using: 30 mL volume of local anesthetics (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) + 10 mg nalbuphine hydrochloride (completed to 2 ml with 0.9% normal saline). | Procedure: Ultrasound (US) guided supraclavicular brachial plexus block<br>* Using 8 mg dexamethasone or 10 mg nalbuphine as adjuvants to (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) in ultrasound (US) guided supraclavicular brachial plexus block<br>|
| Active Comparator: Group III Dexamethasone<br>Ultrasound (US) guided supraclavicular brachial plexus block will be done to the patients who are prepared to undergo upper limb surgeries below the level of the shoulder within the distribution of supraclavicular brachial plexus block using: 30 mL volume of local anesthetics (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) + 2 mL dexamethasone 0.4% (8 mg). | Procedure: Ultrasound (US) guided supraclavicular brachial plexus block<br>* Using 8 mg dexamethasone or 10 mg nalbuphine as adjuvants to (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) in ultrasound (US) guided supraclavicular brachial plexus block<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of postoperative analgesia | Time between onset of sensory block to the first report of postoperative pain at the surgical site that has a VAS visual analogue score ≥ 4. | First 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative pain score Visual Analogue Score | On a scale of 0-10, the patient will be asked to quantify postoperative pain as the following: 0: No pain 10: Maximum/worst imaginable pain. Visual Analog Scale assessment will be done every 5 minutes for first 30 minutes, then hourly for first 8 hours then every 4 hourly till patient complained of pain equivalent to a VAS score of 4. Rescue analgesia (injection of fentanyl 25 mcg intravenous increments) up to 200 μg/hour is administered when VAS score reached 4. | First 24 hours after surgery | 
| The total opioid consumption | Total dose of fentanyl as a rescue analgesic in the first 24 hours | First 24 hours after surgery |