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

March 25, 2022 updated by: Demetra Solomou, National and Kapodistrian University of Athens

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
    • Attiki
      • Athens, Attiki, Greece, 115 27
        • Recruiting
        • National and Kapodistrian University of Athens
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control
Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,without Ketamine as an adjuvant.
Drug: Ropivacaine
Ropivacaine
Procedure: Forearm surgey
Microsurgery Clinic , KAT Hospital Athens
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.
Drug: Ropivacaine
Ropivacaine
Drug: Ketamine
Ketamine
Procedure: Forearm surgey
Microsurgery Clinic , KAT Hospital Athens
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.
Drug: Ropivacaine
Ropivacaine
Drug: Ketamine
Ketamine
Procedure: Forearm surgey
Microsurgery Clinic , KAT Hospital Athens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side Effects
Time Frame: 24 hours
Dizziness, nausea, vomiting, paraesthesia
24 hours
Motor Blockade Score
Time Frame: 24 hours
0=complete paralysis, 1=partial paralysis, 2=no paralysis
24 hours
Anesthesia Onset time
Time Frame: 24 hours
Time from removal of needle to final motor and sensory blockade result
24 hours
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Investigators

  • Study Director: Theodoros Xanthos, Professor, National Kapodistrian University of Athens

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 2022

Primary Completion (ANTICIPATED)

May 1, 2023

Study Completion (ANTICIPATED)

June 1, 2023

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (ACTUAL)

March 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 28, 2022

Last Update Submitted That Met QC Criteria

March 25, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 877/14-01-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan under study

IPD Sharing Time Frame

June 2023

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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