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NCT05297422 Clinical Trial

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

Anesthesia Clinical Trial

Official title:
Administration of Ketamine to Branchial Plexus Block Using Axillary Approach : Comparative Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05297422
Other study ID # 877/14-01-2022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 20, 2022
Est. completion date June 2023

Study information
Verified date March 2022
Source National and Kapodistrian University of Athens
Contact Demetra Solomou
Phone +306987707097
Email Demetra_Sol@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess Ketamine as an adjuvant to Branchial Plexus Blockade.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 81
Est. completion date June 2023
Est. primary completion date May 2023
Accepts healthy volunteers No
Gender All
Age group 16 Years to 70 Years
Eligibility Inclusion Criteria: - BMI 20-35 - ASA score I, II, III Exclusion Criteria: - Mental disorder - Peripheral neuropathy - Severe hepatic or renal disease - Gastrointestinal bleeding history

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Forearm surgey
Microsurgery Clinic , KAT Hospital Athens
Drug:
• Ropivacaine
Ropivacaine
• Ketamine
Ketamine

Locations
Country Name City State
Greece National and Kapodistrian University of Athens Athens Attiki

Sponsors (1)
Lead Sponsor Collaborator
National and Kapodistrian University of Athens

Country where clinical trial is conducted

Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary VAS (Visual Analog Scale) over 24 hours following intervention VAS scale is expressed in integer numbers ranging from 0-10, where 0=no pain, 10= excruciating pain. 24 hours
Secondary Side Effects Dizziness, nausea, vomiting, paraesthesia 24 hours
Secondary Motor Blockade Score 0=complete paralysis, 1=partial paralysis, 2=no paralysis 24 hours
Secondary Anesthesia Onset time Time from removal of needle to final motor and sensory blockade result 24 hours
Secondary Rescue Dose Tramadol 100mg intravenously administered only to patients who claim to be in strong pain within the 24 hours after intervention. 24 hours
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