Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block

Study Overview
=================
Brief Summary
-----------------
The investigators want to compare the effectiveness of dexamethasone and dexmedetomidine as an adjuvant to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset of block and duration of analgesia, so that the investigators can choose the better adjuvant for the investigators routine practice of regional anesthesia.

Detailed Description
-----------------
Ropivacaine is a newer local anesthetic which is structurally related to bupivacaine, but has fewer side effects. It is more cardio stable than bupivacaine, but the onset of action is delayed and the duration of action is shorter than bupivacaine making its use during regional anesthesia less preferable to many anesthesiologists. Steroids like dexamethasone, or alpha-2 agonists like dexmedetomidine are being studied as adjuvants to ropivacaine for brachial plexus block to improve its anesthetic properties and have shown favorable outcome in terms of shortening the onset of block and prolonging the duration of action. But no study has been done to compare their effects. So in this study the investigators want to compare the effectiveness of dexamethasone and dexmedetomidine as an adjuvant to 0.5% ropivacaine for supraclavicular brachial plexus block on the onset of block and duration of analgesia, so that the investigators can choose the better adjuvant for the investigators routine practice of regional anesthesia.

Official Title
-----------------
Dexamethasone Compared With Dexmedetomidine as an Adjuvant to Ropivacaine for Supraclavicular Brachial Plexus Block

Conditions
-----------------
Brachial Plexus Block

Intervention / Treatment
-----------------
* Drug: Ropivacaine and Normal saline
* Drug: Ropivacaine and Dexamethasone
* Drug: Ropivacaine and Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of American Society of Anesthesiologists Physical Status I and II undergoing elective upper limb surgery under supraclavicular brachial plexus block Exclusion Criteria: Patient's refusal to participate Patients weighing less than 40 kg Allergy to study drugs Infection at the site of injection Patients with preexisting neurological deficit Patients with diabetes mellitus Patients on steroids preoperatively Patients with bleeding disorder or coagulopathy Abnormalities in ECG like AV block or symptomatic bradycardia Patients receiving adrenoreceptor agonist or antagonist therapy preoperatively Requirement of conversion to general anesthesia due to inadequate block

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Block with Ropivacaine and Normal saline<br>Patients will receive brachial plexus block with 20 ml 0.5% ropivacaine with 1ml normal saline: Total volume 21 ml | Drug: Ropivacaine and Normal saline<br>* Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 1 ml normal saline<br>|
| Active Comparator: Block with Ropivacaine and Dexamethasone<br>Patients will receive brachial plexus block with 20ml 0.5% ropivacaine with 4mg (1ml) dexamethasone: Total volume 21 ml | Drug: Ropivacaine and Dexamethasone<br>* Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 4mg (1ml) dexamethasone<br>|
| Experimental: Block with Ropivacaine and Dexmedetomidine<br>Patients will receive brachial plexus block with 20ml 0.5% ropivacaine with 50mcg (1ml) dexmedetomidine: Total volume 21 ml | Drug: Ropivacaine and Dexmedetomidine<br>* Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 50 mcg (1ml) dexmedetomidine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of sensory block | Sensory block in the territories of median nerve (palmar surface of index finger), ulnar nerve (palmar surface of little finger), radial nerve (dorsal surface of first web space/ thumb) and musculocutaneous nerve (lateral side of volar surface of forearm) will be assessed by pinprick test using a 3-point scale: 0 - normal sensation, - loss of sensation of pinprick (analgesia), - loss of sensation of touch (anaesthesia). Complete sensory block will be defined as grade 2 sensory block in 3 or more nerve territories. | every 3 minutes until 45 minutes after injection of drug | 
| Onset of motor block | Motor block will be evaluated by thumb flexion/ opposition (median nerve), thumb extension (radial nerve), finger abduction (ulnar nerve) and elbow flexion with forearm in full supination (musculocutaneous nerve) on a 3-point scale for motor function: 0 - normal motor function, - reduced motor strength but able to move, - complete motor block. Complete motor block will be defined as grade 2 motor block in 3 or more nerve territories. | every 3 minutes until 45 minutes after injection of drug | 
| Duration of analgesia |  | Up to 24 hours after onset of block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of sensory block | time from onset of sensory block to complete recovery of anaesthesia on all nerves. | Up to 24 hours after onset of block | 
| Duration of motor block | time from onset of motor block to the recovery of complete motor function of the hand and forearm | Up to 24 hours after onset of block | 
| Incidence of side effects of drugs | Side effects like bradycardia, tachycardia, hypotension, sedation, neurological deficit will be evaluated | Forty-eight hours following the injection of local anesthetics | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brachial plexus block, Ropivacaine, Dexmedetomidine, Dexamethasone, Adjuvants, anesthesia