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The purpose of this study is to assess Ketamine as an adjuvant to Branchial Plexus Blockade.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Axillary Approach to Brachial Plexus Blockade will be performed using 30ml Ropivacaine 0.5% ,without Ketamine as an adjuvant. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Forearm surgey | Procedure | Microsurgery Clinic , KAT Hospital Athens |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Side Effects | Dizziness, nausea, vomiting, paraesthesia | 24 hours |
| Motor Blockade Score | 0=complete paralysis, 1=partial paralysis, 2=no paralysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Demetra Solomou | Contact | +306987707097 | Demetra_Sol@hotmail.com | |
| Theodoros Xanthos | Contact | +302112136842 | theodorosxanthos@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Theodoros Xanthos, Professor | National and Kapodistrian University of Athens | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National and Kapodistrian University of Athens | Recruiting | Athens | Attica | 115 27 | Greece |
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| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
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Plan under study
June 2023
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine | Drug | Ropivacaine |
|
| Ketamine | Drug | Ketamine |
|
| 24 hours |
| Anesthesia Onset time | Time from removal of needle to final motor and sensory blockade result | 24 hours |
| Rescue Dose | Tramadol 100mg intravenously administered only to patients who claim to be in strong pain within the 24 hours after intervention. | 24 hours |
| D000588 |
| Amines |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |