Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block

Study Overview
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Brief Summary
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The investigators compared between dexamethasone and dexmedetomidine when added to levobupivacaine in the quality and duration of ultrasound-guided interscalene block during shoulder arthroscopy.

Detailed Description
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Sixty patients were enrolled and divided into three groups 20 each, Group C received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline. The primary outcome was the postoperative pain which was assessed by Visual analog score(VAS), the secondary outcomes were the onset and duration of sensory and motor block, the total amount of analgesic requirement, and blood cortisol level.

Official Title
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Comparison Between Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Ultrasound Guided Interscalene Block During Shoulder Arthroscopy: A Randomized Controlled Study

Conditions
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Postoperative Analgesia, Postoperative Complications

Intervention / Treatment
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* Drug: Saline
* Drug: Dexamethasone Injection
* Drug: Dexmedetomidine Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sixty healthy patients ASA I-II Aged 18-60 years Of both sexes Scheduled for shoulder arthroscopy using ultrasound interscalene block were enrolled. Exclusion Criteria: Patients with a history of any allergic reactions to levobupivacaine, dexamethasone or α2 agonists All patients with hypertension, cardiac, hepatic, renal or pulmonary diseases, - Patients who were under treatment by α2 agonist or antagonists Pregnant women Psychiatric patients Patients with a previous history or clinical evidence of central or peripheral neurological disease Coagulopathy or anticoagulant/antiaggregant therapy Contralateral phrenic nerve paresis Patients who have an infection at the site of the block. Every patient who had an anatomical or vascular abnormality in the upper extremity were excluded from this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: three groups 20 each, Group C received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. | Drug: Saline<br>* 2 ml normal saline<br>* Other names: normal saline;|
| Active Comparator: Dexamethasone group<br>received 35ml levobupivacaine+8mg dexamethasone | Drug: Dexamethasone Injection<br>* 8 mg dexamethasone<br>* Other names: dexamethsone;|
| Active Comparator: Dexmeteomidine group<br>received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline. | Drug: Dexmedetomidine Hydrochloride<br>* 100 microgram dexmedetomidine<br>* Other names: dexmedetomidine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in postoperative analgesia | Assessed by measuring severity of pain by visual analog score(score 0 to 10 cm with 0= no pain and 10=worst pain imaginable). | During first 2 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative analgesic requirement | Total amount of paracetamol required in mg | During first 2 days after surgery | 
| Hemodynamic parameter | Heart rate | During first 2 days after surgery | 
| Hemodynamic parameter | Mean arterial blood pressure | During first 2 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Dexamethasone, Interscalene