Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Supraclavicular Block

Study Overview
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Brief Summary
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The investigator's aim will be to compare the efficacy of perineural tramadol and dexamethasone added to levobupivacaine in prolonging postoperative analgesia in patient undergoing open reduction and internal fixation for forearm fractures. Primary outcome: duration of postoperative analgesia. Secondary outcome: include [The anesthesia onset time, total rescue analgesic consumption in the 1st 24-hour and the presence of complications and side effects.

Detailed Description
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Strategies to prolong brachial plexus nerve blocks analgesia beyond the pharmacological duration of the local anaesthetic used include placement of indwelling perineural catheters to allow prolonged infusion or the co-administration of adjuvants such as epinephrine, alpha 2 agonists (as clonidine and dexmedetomidine), midazolam, or the corticosteroid dexamethasone . Dexamethasone improves the quality and duration of peripheral nerve block over local anaesthetic alone. This is thought to be mediated by attenuating the release of inflammatory mediators, reducing ectopic neuronal discharge, and inhibiting potassium channel-mediated discharge of nociceptive C-fibres . Tramadol is a unique opioid with two modes of action for inhibition of pain, an opioid action mediated by the μ receptor and a non-opioid action mediated by α-2-adrenergic and serotoninergic activity .The monoaminergic activity of tramadol inhibits the descending pain pathways, resulting in suppression of nociceptive transmission at the spinal level . Tramadol also exhibits local anaesthetic properties by blocking K+ channels .Many studies have characterized the effects of tramadol as an adjuvant to local anaesthetic in brachial plexus block .

Official Title
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Tramadol Versus Dexamethasone as Adjuvant to Levobupivacaine Under Ultrasound Guided Supraclavicular Block of Forearm Fractures

Conditions
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Regional Anesthesia

Intervention / Treatment
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* Drug: Levobupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologist physical status I-II patients older than 18years and scheduled for internal fixation for forearm fractures Both sexes Exclusion Criteria: Patients with known allergy to the study drugs Skin infection at site of needle puncture Significant organ dysfunction Coagulopathy Drug or alcohol abuse Epilepsy and psychiatric illness that would interfere with perception and assessment of pain

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group (T) : 30 patients (Tramadol group)<br>Patient will receive 0.4 mL/kg of 0.5% Levobupivacaine plus 1.5 mg/kg Tramadol. | Drug: Levobupivacaine<br>* Tramadol versus Dexamethasone as adjuvant to Levobupvacain<br>|
| Experimental: Group (D) : 30 patients (Dexamethasone group):<br>Patient will receive 0.4 mL/kg of 0.5% Levobupivacaine plus 8mg of Dexamethasone | Drug: Levobupivacaine<br>* Tramadol versus Dexamethasone as adjuvant to Levobupvacain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of postoperative analgesia in hours | Duration of postoperative analgesia in hours | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The anesthesia onset time | Anasthesia onset | 20 minutes | 
| Dose of Paracetamol as rescue analgesia in mg | Rescue Analgesia in mg | 24 hours | 
| Presence of complications and side effects | complications and side effects | 24 hours |