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出境医 / 临床实验 / Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block (IBBB)

Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block (IBBB)

Study Description
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
Arms and Interventions
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
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

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
Layout table for investigator information
Study Director: mamdouh e lotfy, m.d. emeritus professor
Tracking Information
First Submitted Date  ICMJE April 10, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE July 3, 2016
Actual Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019) 		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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Postoperative analgesic requirement [ Time Frame: During first 2 days after surgery ]
    Total amount of paracetamol required in mg
  • Hemodynamic parameter [ Time Frame: During first 2 days after surgery ]
    Heart rate
  • Hemodynamic parameter [ Time Frame: During first 2 days after surgery ]
    Mean arterial blood pressure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block
Official Title  ICMJE Comparison Between Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Ultrasound Guided Interscalene Block During Shoulder Arthroscopy: A Randomized Controlled Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE
  • Postoperative Analgesia
  • Postoperative Complications
Intervention  ICMJE
  • Drug: Saline
    2 ml normal saline
    Other Name: normal saline
  • Drug: Dexamethasone Injection
    8 mg dexamethasone
    Other Name: dexamethsone
  • Drug: Dexmedetomidine Hydrochloride
    100 microgram dexmedetomidine
    Other Name: dexmedetomidine
Study Arms  ICMJE
  • Placebo Comparator: Control group
    received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block.
    Intervention: Drug: Saline
  • Active Comparator: Dexamethasone group
    received 35ml levobupivacaine+8mg dexamethasone
    Intervention: Drug: Dexamethasone Injection
  • Active Comparator: Dexmeteomidine group
    received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.
    Intervention: Drug: Dexmedetomidine Hydrochloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2019) 		60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1, 2019
Actual Primary Completion Date January 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03940469
Other Study ID Numbers  ICMJE Interscalene Dexmedetomidine
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ashraf magdy eskandr, Menoufia University
Study Sponsor  ICMJE Menoufia University
Collaborators  ICMJE
  • Mamdoh Elsayed Lotfy
  • Osama Abdallah Elsharkawy
  • Basma Abdelhamid Fathy
Investigators  ICMJE
Study Director: mamdouh e lotfy, m.d. emeritus professor
PRS Account Menoufia University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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