Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
22 participants
INTERVENTIONAL
2017-07-17
2018-04-01
Brief Summary
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Detailed Description
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Efficient pain management promoting mobilization and convalescence is essential in an ideal perioperative course. Regional nerve blocks are a central element in postoperative regimes for many patients and it is therefore important that these nerve blocks are both long lasting and efficient. This trial will investigate whether it is possible to optimize the postoperative pain management when adding dexmedetomidine to the local anaesthetic ropivacaine in peripheral nerve blocks.
The prolonging effect of using dexmedetomidine as adjunct in peripheral nerve blocks have been investigated in several studies. However, it remains uncertain whether the effect is mediated by a systemic-, a peripheral- or a combined systemic/peripheral mechanism. In this trial the adjuvating effect of dexmedetomidine will be investigated using an ulnar nerve block.
Method:
The participants will attend two trial days.
On one trial day the volunteers will receive bilateral ulnar nerve blocks. In one arm they will receive the local anaesthetic ropivacaine 4ml 5mg/ml and placebo (saline) and in the other arm ropivacaine 4ml 5mg/ml and dexmedetomidine 100μg. The dexmedetomidine administered perineurally is absorbed and redistributed and will influence the two nerve blocks equally systemically. On the other trial day the participants will receive ropivacaine 4ml 5mg/ml and placebo (saline) and in the other arm ropivacaine 4ml 7.5mg/ml and placebo (saline). The allocation is blinded to volunteer and investigator.
In this setup we therefore have a perineural- and a systemic dexmedetomidine group and also a placebo group , and a group testing if higher doses of local anesthetics will prolong the duration of a nerve block.
The duration of the nerve block will be measured by 3 different tests: pinprick, temperature test (alcohol) and Pain during tonic heat stimulation. All tests are validated within pain research.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Perineural dexmedetomidine
Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml 100ug/ml dexmedetomidine perineurally
Dexmedetomidine perineurally
Dexmedetomidine is added perineurally on one side and will influence the nerve block perineurally on this side. Dexmedetomidine is also absorbed and redistributed systemically and will influence the opposite ulnar nerve block systemically.
Ropivacaine 5mg/ml
Ropivacaine is used in 5mg/ml in the perineural, systemic and placebo nerve blocks.
Systemic dexmedetomidine
Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml isotonic saline (placebo) perineurally + 100ug dexmedetomidine systemically (absorbed and redistributed from the opposite ulnar nerve block)
Ropivacaine 5mg/ml
Ropivacaine is used in 5mg/ml in the perineural, systemic and placebo nerve blocks.
Dexmedetomidine systemically
Dexmedetomidine administered perineurally on one side is absorbed and redistributed systemically and will influence the opposite ulnar nerve block systemically.
Isotonic saline
placebo (saline) is administered perineurally in all but the perineural group.
Placebo
Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml isotonic saline (placebo) perineurally
Ropivacaine 5mg/ml
Ropivacaine is used in 5mg/ml in the perineural, systemic and placebo nerve blocks.
Isotonic saline
placebo (saline) is administered perineurally in all but the perineural group.
High dose Ropivacaine
Ulnar nerve block 4ml ropivacaine 7.5mg/ml + 1ml isotonic saline (placebo) perineurally
Ropivacaine 7.5mg/ml
In the high dose ropivacaine group a ropivacaine concentration of 7.5mg/ml is used.
Isotonic saline
placebo (saline) is administered perineurally in all but the perineural group.
Interventions
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Dexmedetomidine perineurally
Dexmedetomidine is added perineurally on one side and will influence the nerve block perineurally on this side. Dexmedetomidine is also absorbed and redistributed systemically and will influence the opposite ulnar nerve block systemically.
Ropivacaine 5mg/ml
Ropivacaine is used in 5mg/ml in the perineural, systemic and placebo nerve blocks.
Ropivacaine 7.5mg/ml
In the high dose ropivacaine group a ropivacaine concentration of 7.5mg/ml is used.
Dexmedetomidine systemically
Dexmedetomidine administered perineurally on one side is absorbed and redistributed systemically and will influence the opposite ulnar nerve block systemically.
Isotonic saline
placebo (saline) is administered perineurally in all but the perineural group.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA 1-2
* BMI \> 18 to \< 30
* For fertile women: safe contraceptives for the last month and a nega-tive urin HCG.
Exclusion Criteria
* Participants unable to speak or read Danish
* Allergy to study medication.
* Alcohol consumption \>21 units for men and \>14 for women per week
* Daily intake of prescription painkillers within the last 4 weeks.
* Over the counter painkillers during the last 48 hours.
* Neuromuscular defects or wounds on the arms or hands preventing test performance.
* Diabetes Mellitus
* 2\. degree heart block
* Sick sinus node.
* For fertile women a positive urine HCG
18 Years
ALL
Yes
Sponsors
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Zealand University Hospital
OTHER
Responsible Party
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Jakob Hessel Andersen
Anesthesiologist, Staff Specialist
Principal Investigators
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Jakob H Andersen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Department of Anesthesiology, Zealand University Hospital
Locations
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Department of Anesthesiology Zealand University Hospital
Køge, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Jakob H Andersen, MD
Role: primary
References
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Andersen JH, Jaeger P, Grevstad U, Estrup S, Geisler A, Vilhelmsen F, Dahl JB, Laier GH, Ilfeld BM, Mathiesen O. Systemic dexmedetomidine is not as efficient as perineural dexmedetomidine in prolonging an ulnar nerve block. Reg Anesth Pain Med. 2019 Mar;44(3):333-340. doi: 10.1136/rapm-2018-100089. Epub 2019 Jan 23.
Other Identifiers
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2016-004883-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
REG-158-2016
Identifier Type: -
Identifier Source: org_study_id