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Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block (IBBB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03940469
Recruitment Status : Completed
First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Collaborators:
Mamdoh Elsayed Lotfy
Osama Abdallah Elsharkawy
Basma Abdelhamid Fathy
Information provided by (Responsible Party):
ashraf magdy eskandr, Menoufia University

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

Condition or disease Intervention/treatment Phase
Postoperative Analgesia Postoperative Complications Drug: Saline Drug: Dexamethasone Injection Drug: Dexmedetomidine Hydrochloride Phase 4

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Masking Description: both the patients and the observer were blind to the treatment groups
Primary Purpose: Treatment
Official Title: Comparison Between Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Ultrasound Guided Interscalene Block During Shoulder Arthroscopy: A Randomized Controlled Study
Actual Study Start Date : July 3, 2016
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : January 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Control group
received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block.
 Drug: Saline
2 ml normal saline
Other Name: normal saline
Active Comparator: Dexamethasone group
received 35ml levobupivacaine+8mg dexamethasone
 Drug: Dexamethasone Injection
8 mg dexamethasone
Other Name: dexamethsone
Active Comparator: Dexmeteomidine group
received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.
 Drug: Dexmedetomidine Hydrochloride
100 microgram dexmedetomidine
Other Name: dexmedetomidine


Outcome Measures
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Primary Outcome Measures :
  1. Changes in postoperative analgesia [ Time Frame: During first 2 days after surgery ]
    Assessed by measuring severity of pain by visual analog score(score 0 to 10 cm with 0= no pain and 10=worst pain imaginable).


Secondary Outcome Measures :
  1. Postoperative analgesic requirement [ Time Frame: During first 2 days after surgery ]
    Total amount of paracetamol required in mg

  2. Hemodynamic parameter [ Time Frame: During first 2 days after surgery ]
    Heart rate

  3. Hemodynamic parameter [ Time Frame: During first 2 days after surgery ]
    Mean arterial blood pressure


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940469


Locations
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Egypt
Ashraf Eskandr
Shibīn Al Kawm, Menoufiya, Egypt, 1234
Sponsors and Collaborators
Menoufia University
Mamdoh Elsayed Lotfy
Osama Abdallah Elsharkawy
Basma Abdelhamid Fathy
Investigators
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Study Director: mamdouh e lotfy, m.d. emeritus professor
More Information
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Responsible Party: ashraf magdy eskandr, Assistant Professor of Anesthesia, ICU, Menoufia University
ClinicalTrials.gov Identifier: NCT03940469    
Other Study ID Numbers: Interscalene Dexmedetomidine
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by ashraf magdy eskandr, Menoufia University:
Dexmedetomidine
Dexamethasone
Interscalene
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes
Dexamethasone
Dexamethasone acetate
Dexmedetomidine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
 Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action