Effect of Ultra-low Dose Naloxone During Supraclavicular Brachial Plexus Block on Post-operative Opioi

Study Overview
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Brief Summary
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Effective post-operative pain control can reduce patient morbidity and affect the patient outcome. Brachial plexus block is one of them, a popular and widely employed regional nerve block technique for perioperative anesthesia and analgesia for surgery of the upper extremity. Different drugs have been used as adjuvants with local anesthetics in brachial plexus block to achieve quick, dense and prolonged block like Morphine, Pethidine, Clonidine, Dexmedetomidine. Naloxone is opioid antagonists which could selectively block the excitatory effects of opioids. it release endorphins and also displace endorphins from receptor site .it also reduce the opioid induced side effects, such as vomiting, nausea, pruritus, and respiratory depression.

Detailed Description
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The aim of this study is to evaluate the effect of ultra-low dose of naloxone when added to bupivacaine %.05 in supraclavicular brachial plexus block in orthopedic upper limb surgery and if it enhances the anti-nociceptive effect of post-operative opioid Effect of naloxone on anti-nociceptive criteria of post -operative opioid will be estimated by detecting the interval between each analgesic dose of post-operative opioid.

Official Title
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Effect of Ultra-low Dose Naloxone During Supraclavicular Brachial Plexus Block on the Anti-nociceptive Criteria of Post-operative Opioid in Orthopedic Upper Limb Surgeries

Conditions
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Upper Extremity Trauma

Intervention / Treatment
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* Drug: Bupivacaine plus naloxone
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiology (ASA) physical state class Ι and II Elective upper limb orthopedic surgery (hand, forearm and elbow) Duration of surgery ≤180 min BMI ≤30 kg/m2 Exclusion Criteria: History of allergy to the drug of the study. Coagulation disorders Infection at the puncture site. Pregnancy Opioid abuse. Abuse of tranquilizers

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bupivacaine plus naloxone<br>Patients will receive brachial plexus block using bupivacaine plus naloxone. | Drug: Bupivacaine plus naloxone<br>* Patients received 20 mL bupivacaine 0.5% plus 100 ng naloxone (1ml) in 2ml saline.(naloxone ampoule 0.4mg will dilute in 400ml of saline then 1ml of it will dilute in 10 ml saline, so each ml will have 100ng naloxone)<br>|
| Placebo Comparator: Bupivacaine<br>Patients will receive brachial plexus block using bupivacaine. | Drug: Bupivacaine<br>* Patients will be injected ultrasound guided in their brachial plexus by 20 mL bupivacaine 0.5% plus 3 ml of saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of ultra-low dose naloxone on the post operative opioid | by estimate the analgesic requirements of opioids and the interval between each opioid dose in 48 hour post operative | for 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of sensory block | will be defined as the time interval between the complete sensory block (complete absence of pinprick response) and first experience with postoperative pain | For 48 hours after surgery | 
| Duration of motor block | defined as the time interval between complete paralysis (Lovett rating scale = 0) and complete recovery (Lovett rating scale = 6) | For 48 hours after surgery | 
| Onset time of sensory block | defined as the time between the end of the last injection and complete absence of pinprick response in all nerve distribution | For 48 hours after surgery | 
| Onset time of motor block | defined as the time between the end of the last injection and complete paralysis (Lovett rating scale = 0) in all nerve distributions | For 48 hours after surgery | 
| Severity of post-operative pain | will be measured by visual analogue scale (VAS) where 0 was equal to no pain and 10 indicated the worst possible pain | For 48 hours after surgery | 
| 1st time of analgesic request | First need for rescue opioid after surgery | For 48 hours after surgery |