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

NCT ID: NCT05297422

Last Updated: 2022-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-20

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Branchial Plexus Blockade Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control

Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,without Ketamine as an adjuvant.

Group Type ACTIVE_COMPARATOR

Forearm surgey

Intervention Type PROCEDURE

Microsurgery Clinic , KAT Hospital Athens

Ropivacaine

Intervention Type DRUG

Ropivacaine

Ketamine IV

Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg intravenously.

Group Type ACTIVE_COMPARATOR

Forearm surgey

Intervention Type PROCEDURE

Microsurgery Clinic , KAT Hospital Athens

Ropivacaine

Intervention Type DRUG

Ropivacaine

Ketamine

Intervention Type DRUG

Ketamine

Ketamine Regional

Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg regionally.

Group Type ACTIVE_COMPARATOR

Forearm surgey

Intervention Type PROCEDURE

Microsurgery Clinic , KAT Hospital Athens

Ropivacaine

Intervention Type DRUG

Ropivacaine

Ketamine

Intervention Type DRUG

Ketamine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Forearm surgey

Microsurgery Clinic , KAT Hospital Athens

Intervention Type PROCEDURE

Ropivacaine

Ropivacaine

Intervention Type DRUG

Ketamine

Ketamine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Mental disorder
* Peripheral neuropathy
* Severe hepatic or renal disease
* Gastrointestinal bleeding history
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Demetra Solomou

Anaesthesiology Resident at KAT and Masters Student at National and Kapodistrian University of Athens

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Theodoros Xanthos, Professor

Role: STUDY_DIRECTOR

National Kapodistrian University of Athens

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National and Kapodistrian University of Athens

Athens, Attica, Greece

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Greece

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Demetra Solomou

Role: CONTACT

+306987707097

Theodoros Xanthos

Role: CONTACT

+302112136842

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ioanna Tessi

Role: primary

+302112136842

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

877/14-01-2022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.