Branchial Plexus BlockadeNCT05297422
Axillary Approach to Brachial Plexus Blockade Using Ketamine, Regional Versus Intravenous Administration
A study testing Forearm surgey, Ropivacaine and Ketamine in people with Branchial Plexus Blockade and Anesthesia, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
The purpose of this study is to assess Ketamine as an adjuvant to Branchial Plexus Blockade. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Branchial Plexus Blockade, Anesthesia
- What is being tested?
- Forearm surgey, Ropivacaine and Ketamine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteGreece
- Study dates
- 20 Jan 2022to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- BMI 20-35
- ASA score I, II, III
Who cannot join
- Mental disorder
- Peripheral neuropathy
- Severe hepatic or renal disease
- Gastrointestinal bleeding history
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
National and Kapodistrian University of Athens
Athens, Attica, 115 27
Ioanna Tessi, +302112136842, ioannatessi@yahoo.com
About this study
Official title: 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.
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.
- Conditions
- Branchial Plexus Blockade, Anesthesia
- Being tested
- Forearm surgey, Ropivacaine, Ketamine
- Keywords
- Axillary Approach, Ketamine, Adjuvant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forearm surgeyProcedure or surgery
Microsurgery Clinic , KAT Hospital Athens
RopivacaineDrug
Ropivacaine
KetamineDrug
Ketamine
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,without Ketamine as an adjuvant. Receives: Procedure: Forearm surgey; Drug: Ropivacaine |
| Ketamine IV | Active comparator | Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg intravenously. Receives: Procedure: Forearm surgey; Drug: Ropivacaine; Drug: Ketamine |
| Ketamine Regional | Active comparator | Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg regionally. Receives: Procedure: Forearm surgey; Drug: Ropivacaine; Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (4)
Side Effects
Dizziness, nausea, vomiting, paraesthesia
Measured: 24 hours
Motor Blockade Score
0=complete paralysis, 1=partial paralysis, 2=no paralysis
Measured: 24 hours
Anesthesia Onset time
Time from removal of needle to final motor and sensory blockade result
Measured: 24 hours
Rescue Dose
Tramadol 100mg intravenously administered only to patients who claim to be in strong pain within the 24 hours after intervention.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start20 Jan 2022
- Primary completionMay 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Branchial Plexus BlockadeStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demetra Solomou, National and Kapodistrian University of Athens
- Investigators
- Theodoros Xanthos, Professor, Study director, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297422
- Sponsor's protocol ID
- 877/14-01-2022
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2022
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan under study
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Ketamine to Branchial Plexus Block Using Axillary Approach : Comparative Study
- ClinicalTrials.gov ID
- NCT05297422
- Acronym / sponsor ID
- 877/14-01-2022
- Conditions
- Branchial Plexus Blockade, Anesthesia
- Keywords
- Axillary Approach, Ketamine, Adjuvant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 28 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Forearm surgey, Drug: RopivacaineAxillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,without Ketamine as an adjuvant. |
| Ketamine IV | Active comparator | Procedure: Forearm surgey, Drug: Ropivacaine, Drug: KetamineAxillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg intravenously. |
| Ketamine Regional | Active comparator | Procedure: Forearm surgey, Drug: Ropivacaine, Drug: KetamineAxillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,with Ketamine as an adjuvant 30mg regionally. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- BMI 20-35
- ASA score I, II, III
Key exclusion criteria (4 listed)
- Mental disorder
- Peripheral neuropathy
- Severe hepatic or renal disease
- Gastrointestinal bleeding history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forearm surgeyMicrosurgery Clinic , KAT Hospital Athens | Procedure or surgery | Control, Ketamine IV, Ketamine Regional |
| RopivacaineRopivacaine | Drug | Control, Ketamine IV, Ketamine Regional |
| KetamineKetamine | Drug | Ketamine IV, Ketamine Regional |
Primary outcome
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.
4 secondary outcomes
Side Effects
Time frame: 24 hours
Motor Blockade Score
Time frame: 24 hours
Anesthesia Onset time
Time frame: 24 hours
Rescue Dose
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2022.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Plan under study
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodoros Xanthos, Professor study director
National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forearm surgey, Ropivacaine and Ketamine in people with Branchial Plexus Blockade and Anesthesia, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Demetra Solomou (+306987707097, Demetra_Sol@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (Visual Analog Scale) over 24 hours following intervention (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2022.