Effect of Dexmedetomidine as Adjuvant to Ropivacaine for Brachial Plexus Block

Study Overview
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Brief Summary
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Brachial plexus block is used for upper limb surgery. Local anesthesia alone for brachial plexus block provides good operative conditions, but have short duration of postoperative analgesia. Hence, various adjuvants to local anaesthetic agents to prolong the duration of peripheral nerve, analgesia. However, results are either inconclusive or associated with side effects. The purpose of this study is to determine whether dexmedetomidine as an adjuvant to ropivacaine in brachial plexus block improve quality of block in terms of duration of post operative analgesia.

Official Title
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Effect of Dexmedetomidine as Adjuvant to Ropivacaine for Brachial Plexus Block

Conditions
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Local Anesthesia Adjuvants, Upper Extremity Fracture, Brachial Plexus Block

Intervention / Treatment
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* Drug: ropivacaine, lidocaine with adrenaline
* Drug: Dexmedetomidine, ropivacaine, lidocaine with adrenaline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status I and II patients, weight 45 to 74 kg Elective upper limb surgery under brachial plexus block Exclusion Criteria: known hypersensitivity or contraindication to ropivacaine, lidocaine and dexmedetomidine Pregnant or lactating mothers Hepatic, renal or cardiopulmonary abnormalities Long term analgesic therapy

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group R<br>0.35% ropivacaine 20ml, 1.5% lidocaine with adrenaline 10ml = 30 ml | Drug: ropivacaine, lidocaine with adrenaline<br>* Group R includes 0.35% ropivacaine 20ml, 1.5 % lidocaine with adrenaline 10ml<br>|
| Experimental: Group RD<br>0.35% ropivacaine and 1mcg/ kg dexmedetomidine (20 ml), 1.5% lidocaine with adrenaline (10ml) = 30 ml | Drug: Dexmedetomidine, ropivacaine, lidocaine with adrenaline<br>* Dexmedetomidine 1mcg/kg and 0.35% ropivacaine with normal saline (20ml), 1.5% lidocaine with adrenaline (10ml) in group RD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the duration of analgesia after brachial plexus block with ropivacaine and dexmedetomidine | Analgesia will be assessed with the help of Visual analogue score ( VAS). VAS greater than 3 will be given inj.ketorolac 30mg IV. | 5 months | 
| Assess the onset of sensory and motor block after brachial plexus block with ropivacaine and dexmedetomidine | Sensory block assessed by 3point scale 0 normal sensation loss of sensation of pinprick loss of sensation of touch Duration of sensory block, defined as time interval between complete sensory block and complete resolution of anesthesia (score 0).Motor blockade assessed by modified Bromage scale (MBS) 0-able to raise extended arm to 90 degree for full two seconds able to flex elbow, move fingers but unable to raise extended arm unable to flex elbow but able to move fingers unable to move arm, elbow, fingers Duration of motor block defined as time interval from complete motor block to recovery of complete motor function (MBS 0). | 5 months | 
| Assess the duration of sensory and motor block after brachial plexus block with ropivacaine and dexmedetomidine | Duration of sensory block, defined as time interval between complete sensory block and complete resolution of anesthesia (score 0). Duration of motor block defined as time interval from complete motor block to recovery of complete motor function (MBS 0). | 5months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess any complications of study drugs | Complications like bradycardia assessed by continue ECG monitoring, Hypotension will be assessed by NIBP | 5 months |