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

N

National and Kapodistrian University of Athens

Status

Unknown

Conditions

Branchial Plexus Blockade
Anesthesia

Treatments

Procedure: Forearm surgey
Drug: Ketamine
Drug: Ropivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT05297422
877/14-01-2022

Details and patient eligibility

About

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

Full 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.

Enrollment

81 estimated patients

Sex

All

Ages

16 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Mental disorder
  • Peripheral neuropathy
  • Severe hepatic or renal disease
  • Gastrointestinal bleeding history

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

81 participants in 3 patient groups

Control
Active Comparator group
Description:
Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,without Ketamine as an adjuvant.
Treatment:
Procedure: Forearm surgey
Drug: Ropivacaine
Ketamine IV
Active Comparator group
Description:
Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg intravenously.
Treatment:
Drug: Ketamine
Procedure: Forearm surgey
Drug: Ropivacaine
Ketamine Regional
Active Comparator group
Description:
Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg regionally.
Treatment:
Drug: Ketamine
Procedure: Forearm surgey
Drug: Ropivacaine

Trial contacts and locations

1

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Central trial contact

Theodoros Xanthos; Demetra Solomou

Data sourced from clinicaltrials.gov

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