Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Axillary Approach to Brachial Plexus Blockade Using Ketamine, Regional Versus Intravenous Administration

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05297422
Recruitment Status : Recruiting
First Posted : March 28, 2022
Last Update Posted : March 28, 2022
Sponsor:
Information provided by (Responsible Party):
Demetra Solomou, National and Kapodistrian University of Athens

Tracking Information
First Submitted Date  ICMJE March 16, 2022
First Posted Date  ICMJE March 28, 2022
Last Update Posted Date March 28, 2022
Actual Study Start Date  ICMJE January 20, 2022
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2022)
VAS (Visual Analog Scale) over 24 hours following intervention [ Time Frame: 24 hours ]
VAS scale is expressed in integer numbers ranging from 0-10, where 0=no pain, 10= excruciating pain.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2022)
  • Side Effects [ Time Frame: 24 hours ]
    Dizziness, nausea, vomiting, paraesthesia
  • Motor Blockade Score [ Time Frame: 24 hours ]
    0=complete paralysis, 1=partial paralysis, 2=no paralysis
  • Anesthesia Onset time [ Time Frame: 24 hours ]
    Time from removal of needle to final motor and sensory blockade result
  • Rescue Dose [ Time Frame: 24 hours ]
    Tramadol 100mg intravenously administered only to patients who claim to be in strong pain within the 24 hours after intervention.
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 Axillary Approach to Brachial Plexus Blockade Using Ketamine, Regional Versus Intravenous Administration
Official Title  ICMJE Administration of Ketamine to Branchial Plexus Block Using Axillary Approach : Comparative Study
Brief Summary The purpose of this study is to assess Ketamine as an adjuvant to Branchial Plexus Blockade.
Detailed Description After being informed about the study, patients giving written informed consent will undergo anaesthesia using the Ultrasound Guided Axillary Approach to Brachial Plexus Blockade, in order to undergo forearm surgery. The purpose of this study is to assess whether Ketamine as an adjuvant lengthens sensory and motor blockade and whether it has an effect on "rebound pain" when the anaesthetic effect fades. Therefore the study will compare intravenous, regional and no administration of Ketamine as an adjuvant to Branchial Plexus Blockade. Patients will be asked to fill in a Pain VAS (Visual Analog Scale) for 24 hours following the intervention, in order to assess effectiveness of each anaesthetic method. Side effects, onset time, motor blockade score and rescue dose are also recorded.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Branchial Plexus Blockade
  • Anesthesia
Intervention  ICMJE
  • Procedure: Forearm surgey
    Microsurgery Clinic , KAT Hospital Athens
  • Drug: Ropivacaine
    Ropivacaine
  • Drug: Ketamine
    Ketamine
Study Arms  ICMJE
  • Active Comparator: Control
    Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,without Ketamine as an adjuvant.
    Interventions:
    • Procedure: Forearm surgey
    • Drug: Ropivacaine
  • Active Comparator: Ketamine IV
    Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg intravenously.
    Interventions:
    • Procedure: Forearm surgey
    • Drug: Ropivacaine
    • Drug: Ketamine
  • Active Comparator: Ketamine Regional
    Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg regionally.
    Interventions:
    • Procedure: Forearm surgey
    • Drug: Ropivacaine
    • Drug: Ketamine
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 25, 2022)
81
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date May 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI 20-35
  • ASA score I, II, III

Exclusion Criteria:

  • Mental disorder
  • Peripheral neuropathy
  • Severe hepatic or renal disease
  • Gastrointestinal bleeding history
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Demetra Solomou +306987707097 Demetra_Sol@hotmail.com
Contact: Theodoros Xanthos +302112136842 theodorosxanthos@yahoo.com
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05297422
Other Study ID Numbers  ICMJE 877/14-01-2022
Has Data Monitoring Committee No
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: Yes
Plan Description: Plan under study
Supporting Materials: Study Protocol
Time Frame: June 2023
Current Responsible Party Demetra Solomou, National and Kapodistrian University of Athens
Original Responsible Party Same as current
Current Study Sponsor  ICMJE National and Kapodistrian University of Athens
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Theodoros Xanthos, Professor National Kapodistrian University of Athens
PRS Account National and Kapodistrian University of Athens
Verification Date March 2022

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