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Status unknownNCT05297422Updated Mar 28, 2022

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

An interventional study of Forearm surgey and Ropivacaine in Branchial Plexus Blockade and Anesthesia, sponsored by National and Kapodistrian University of Athens. Status unknown at 1 site in Greece. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-03-28.

Sponsored by National and Kapodistrian University of Athens · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Non-randomized
Ages
16 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Branchial Plexus Blockade
  • Anesthesia

Keywords

  • Axillary Approach
  • Ketamine
  • Adjuvant
03

In context

Lead sponsor

National and Kapodistrian University of Athens is the lead sponsor of 168 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Mental disorder
  • Peripheral neuropathy
  • Severe hepatic or renal disease
  • Gastrointestinal bleeding history
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
81 participants (estimated)

Study arms

  • Active comparator
    Control

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

    Procedure: Forearm surgey · Drug: Ropivacaine

  • 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.

    Procedure: Forearm surgey · Drug: Ropivacaine · Drug: Ketamine

  • 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.

    Procedure: Forearm surgey · Drug: Ropivacaine · Drug: Ketamine

Interventions

  • ProcedureForearm surgey

    Microsurgery Clinic , KAT Hospital Athens

  • DrugRopivacaine

    Ropivacaine

  • DrugKetamine

    Ketamine

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 24 hours

Secondary outcomes

  1. Side Effects

    Dizziness, nausea, vomiting, paraesthesia

    Time frame: 24 hours

  2. Motor Blockade Score

    0=complete paralysis, 1=partial paralysis, 2=no paralysis

    Time frame: 24 hours

  3. Anesthesia Onset time

    Time from removal of needle to final motor and sensory blockade result

    Time frame: 24 hours

  4. Rescue Dose

    Tramadol 100mg intravenously administered only to patients who claim to be in strong pain within the 24 hours after intervention.

    Time frame: 24 hours

07

Study locations

1 of 1 sites recruiting
  • National and Kapodistrian University of Athens
    Athens, Attiki 115 27, Greece
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Plan under study

Supporting information: Study protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05297422
Lead sponsor
National and Kapodistrian University of Athens
Responsible party
Demetra Solomou (Anaesthesiology Resident at KAT and Masters Student at National and Kapodistrian University of Athens, National and Kapodistrian University of Athens) — Principal investigator
First posted
Mar 28, 2022
Start date
Jan 20, 2022
Primary completion
May 2023 (estimated)
Completion
Jun 2023 (estimated)
Last update
Mar 28, 2022

Study contacts

Demetra Solomou
Contact
Demetra_Sol@hotmail.com
+306987707097
Theodoros Xanthos
Contact
theodorosxanthos@yahoo.com
+302112136842
Theodoros Xanthos, Professor
study director · National Kapodistrian University of Athens

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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