Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block

Study Overview
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Brief Summary
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The goal of the study is to compare the duration of analgesia in patients undergoing forearm or hand surgery with a supraclavicular brachial plexus block, who receive either iv dexmedetomidine or placebo.

Detailed Description
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Most surgical interventions on the forearm and the hand in Valais Hospital are performed under regional anesthesia. This ensures intraoperative patient comfort and reduces pain during the first 6 to 12 postoperative hours. A very common strategy to provide anesthesia of the arm is to inject local anesthetics in the region over the clavicle around the brachial plexus. This supraclavicular brachial plexus block is routinely performed in Valais Hospital and is always done under ultrasound guidance. A drawback of locoregional anesthesia is the recurrence of pain once the effect of the block wears off after approximately 6 to 8 hours. This phenomenon is called rebound pain. It and can be very severe and debilitating, can significantly impact postoperative recovery and may also preclude ambulatory surgery as well as early mobilization and physiotherapy. Therefore, strategies that prolong the analgesic effect of locoregional anesthesia are warranted. Dexmedetomidine is a selective α2-adrenoceptor agonists with sedative and analgesic properties. It has been shown to prolong the analgesic duration of local anesthetics when administered intravenously. However, the association of dexmedetomidine with long-acting local anesthetics for supraclavicular brachial plexus block has not been systematically investigated.

Official Title
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Analgesic Efficacy of Intravenous Dexmedetomidine for Supraclavicular Plexus Block: a Randomized Double-blinded Placebo Controlled Clinical Trial

Conditions
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Surgery

Intervention / Treatment
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* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elbow, forearm or hand surgery under supraclavicular brachial plexus block Patients who are ASA physical status I-III Exclusion criteria Patient refusal ASA physical status IV History of hypersensitivity or intolerance to dexmedetomidine History of hypersensitivity or intolerance to dexamethasone History of hypersensitivity or intolerance to local anesthetics History of recent (< 1 year) cerebrovascular insult Second or third degree heart block Uncontrolled hypotension Conditions contraindicating supraclavicular brachial plexus block: neurological deficit or neuropathy of the arm, severe hepatic dysfunction (Child B and C), coagulopathy, malignancy or infection in the area above the clavicle Chronic opioid use Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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
Interventional Model Description: Patients undergoing forearm or hand surgery under supraclavicular brachial plexus block, receiving either additional intravenous dexmedetomidine or placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intravenous dexmedetomidine<br>Patients will receive intravenous dexmedetomidine 1 mcg/kg just after the supraclavicular brachial plexus block is completed | Drug: Dexmedetomidine<br>* After completion of supraclavicular brachial plexus block patients will receive intravenous dexmedetomidine 1 mcg/kg<br>* Other names: Dexdor;|
| Placebo Comparator: Placebo<br>Patients will receive intravenous placebo (normal saline) just after the supraclavicular brachial plexus is completed | Drug: Dexmedetomidine<br>* After completion of supraclavicular brachial plexus block patients will receive intravenous dexmedetomidine 1 mcg/kg<br>* Other names: Dexdor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of analgesia | time in minutes from end of injection of local anesthetic till first analgesic request | 24 hours on day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of motor block | time in minutes from completion of locoregional anesthesia and the moment the patient can again mobilize the arm | 24 hours on day of surgery | 
| Duration of sensory block | time in minutes from completion of locoregional anesthesia and the moment the patient regains sensation of the arm | 24 hours on day of surgery | 
| Pain scores at rest | Pain scores at rest on numeric scale, 0=no pain at all to 10=worst pain imaginable | 4, 24, 48 hours postoperatively | 
| Pain scores on movement | Pain scores on movement, on numeric scale, 0=no pain at all to 10=worst pain imaginable | 4, 24, 48 hours postoperatively | 
| Cumulative amount of opiate analgesic medication consumed | in intravenous morphine equivalents (mg) | 24, 48 hours postoperatively | 
| Patient satisfaction | on 4 point Likert scale: dissatisfied / neutral / satisfied / extremely satisfied | 7 days postoperatively | 
| Total number of dexmedetomidine-related side effects | Total number of dexmedetomidine-related side effects, in particular bradycardia and hypotension | 24 hours postoperatively | 
| Dexmedetomidine-related side effects | Number and % of patients who experience at least one dexmedetomidine-related side effect | 24 hours postoperatively | 
| Opioid-related side effect | Number and % of patients who experience at least one opioid-related side effect | 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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locoregional anesthesia, postoperative analgesia, hand surgery, dexmedetomidine