Duration of Analgesia With Dexmedetomidine and Ropivacaine in Brachial Plexus Block

Study Overview
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Brief Summary
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This is a prospective, randomized, double blind study of adding dexmedetomidine to ropivacaine for Brachial plexus block and assessing the analgesia with VAS pain scales(0-10), Satisfaction scale by VAS scale(0-10) and time to first analgesic consumption. This study mainly aims to investigate whether addition of dexmedetomidine helps in increasing the duration of analgesia.

Detailed Description
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In our institute ropivacaine is used for all the peripheral nerve blocks. This a prospective, randomized, double blind clinical trial study comparing the addition of dexmedetomidine vs ropivacaine alone in brachial plexus nerve block. After screening the patient with the inclusion criteria, an informed consent is obtained from the patient by one of the co-investigator. Adjuvants to local anesthetics are commonly added to prolong the duration of the peripheral nerve block. Sometimes patients have other added comorbidities along with high BMI with history of chronic pain where prolonging the duration of the peripheral nerve block would help with decreased narcotic consumption in the perioperative period with minimal side effects related to the local anesthetics(LA) as well as the adjuncts. Dexmedetomidine is proven to be better than Clonidine in a recent study. Also perineural dexmedetomidine is proven to be more efficacious compared to intravenous dosing. The investigators are evaluating whether adding dexmedetomidine to standard dose of Ropivacaine helps in prolonging the duration of the peripheral nerve block with minimal side effects.

Official Title
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A Randomized, Prospective, Double Blind Clinical Trial to Investigate the Increase in Duration of Analgesia With Addition of 0.25mcg/kg of Dexmedetomidine (DEX) to 25 ml of 0.5%Ropivacaine in Supraclavicular Brachial Plexus Block.

Conditions
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Analgesia, Pain, Acute, Peripheral Nerve Block

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age-18years and above Both male and female patients BMI->18 Elective Subacute upper extremity fractures Exclusion Criteria: Chronic pain patients (Pain persisting for more than 3-6months or past the normal healing time of any injury, influences every aspect of a person's quality of life.) Patients with drug abuse history in the past 6 months ESRD Hepatic failure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: This is a prospective, randomized, double blind study of adding dexmedetomidine 0.25mcg/kg body weight to standard dose (25ml) of 0.5%ropivacaine for Brachial plexus block and assessing the analgesia with VAS pain scales (0-10), Satisfaction scale by VAS scale (0-10) and time to first analgesic consumption.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ropivacaine only<br>0.5% ropivacaine | Drug: ropivacaine<br>* Standard of care 0.5%ropivacaine<br>* Other names: naropin;|
| Active Comparator: ropivacaine with dexmedetomidine<br>25ml of 0.5%ropivacaine with 0.25mcg/kg of dexmedetomidine | Drug: Dexmedetomidine<br>* Addition of Dexmedetomidine in block .25mcg/kg of dexmedetomidine<br>* Other names: precedex;Drug: ropivacaine<br>* Standard of care 0.5%ropivacaine<br>* Other names: naropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Effect | To determine the change in duration of analgesia by the time to first intake of analgesic medicine by adding 0.25mcg/kg of dexmedetomidine to 25 ml of 0.5%ropivacaine in Brachial plexus nerve block. | Immediate pre-op until 36hours post block | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potential Side Effects | To look for the potential side effects of dexmedetomidine like bradycardia and hypotension in the intraoperative and immediate post-operative period. | Immediate pre-op until 36hours post block | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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upper extremity bone fracture