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

Not Applicable

• Conditions: Anesthesia; Branchial Plexus Blockade
• Interventions: Procedure: Forearm surgey; Drug: Ropivacaine; Drug: Ketamine

• Registration Number: NCT05297422
• Lead Sponsor: National and Kapodistrian University of Athens

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 Timeline

• Study Start: 2022-01-20
• Status Verified: 2022-03
• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-25
• Last Update Submitted: 2022-03-25
• Study First Posted: 2022-03-28
• Last Update Posted: 2022-03-28
• Primary Completion: 2023-05
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 81

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine Regional	Ropivacaine	Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg regionally.
Control	Forearm surgey	Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,without Ketamine as an adjuvant.
Control	Ropivacaine	Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,without Ketamine as an adjuvant.
Ketamine IV	Forearm surgey	Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg intravenously.
Ketamine IV	Ketamine	Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg intravenously.
Ketamine Regional	Forearm surgey	Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg regionally.
Ketamine IV	Ropivacaine	Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg intravenously.
Ketamine Regional	Ketamine	Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg regionally.

Primary Outcome Measures

Name	Time	Method
VAS (Visual Analog Scale) over 24 hours following intervention	24 hours	VAS scale is expressed in integer numbers ranging from 0-10, where 0=no pain, 10= excruciating pain.

Secondary Outcome Measures

Name	Time	Method
Motor Blockade Score	24 hours	0=complete paralysis, 1=partial paralysis, 2=no paralysis
Side Effects	24 hours	Dizziness, nausea, vomiting, paraesthesia
Anesthesia Onset time	24 hours	Time from removal of needle to final motor and sensory blockade result
Rescue Dose	24 hours	Tramadol 100mg intravenously administered only to patients who claim to be in strong pain within the 24 hours after intervention.

Trial Locations

Locations (1)

National and Kapodistrian University of Athens; 🇬🇷 Athens, Attiki, Greece