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Perineural Dexmedetomidine for Ulnar Nerve Block.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03222323
Recruitment Status : Unknown
Verified July 2017 by Jakob Hessel Andersen, Zealand University Hospital.
Recruitment status was:  Recruiting
First Posted : July 19, 2017
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):
Jakob Hessel Andersen, Zealand University Hospital

Brief Summary:
The aim of this trial is to investigate if dexmedetomidine prolongs the duration of an ulnar nerve block. By using healthy volunteers the investigators can perform bilateral ulnar nerve blocks and thereby control for a systemic effect to clarify if the effect is actually peripheral or systemic. The investigators hypothesis is that dexmedetomidine as an adjunct to a local anaesthetic prolongs the duration of a peripheral nerve block by a peripheral mechanism.

Condition or disease Intervention/treatment Phase
Healthy Drug: Dexmedetomidine perineurally Drug: Ropivacaine 5mg/ml Drug: Ropivacaine 7.5mg/ml Drug: Dexmedetomidine systemically Drug: Isotonic saline Phase 2

Detailed Description:

Background:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The participants will attend two trial days and receive two treatments on each trial days
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Perineural Dexmedetomidine Prolong the Duration of an Ulnar Nerve Block When Controlling for Possible Systemic Effects?
Actual Study Start Date : July 17, 2017
Estimated Primary Completion Date : January 1, 2018
Estimated Study Completion Date : April 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Perineural dexmedetomidine
Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml 100ug/ml dexmedetomidine perineurally
Drug: 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.
Other Name: Dexdor

Drug: Ropivacaine 5mg/ml
Ropivacaine is used in 5mg/ml in the perineural, systemic and placebo nerve blocks.
Other Name: Naropine

Active Comparator: 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)
Drug: Ropivacaine 5mg/ml
Ropivacaine is used in 5mg/ml in the perineural, systemic and placebo nerve blocks.
Other Name: Naropine

Drug: Dexmedetomidine systemically
Dexmedetomidine administered perineurally on one side is absorbed and redistributed systemically and will influence the opposite ulnar nerve block systemically.
Other Name: dexdor

Drug: Isotonic saline
placebo (saline) is administered perineurally in all but the perineural group.
Other Name: Placebo

Placebo Comparator: Placebo
Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml isotonic saline (placebo) perineurally
Drug: Ropivacaine 5mg/ml
Ropivacaine is used in 5mg/ml in the perineural, systemic and placebo nerve blocks.
Other Name: Naropine

Drug: Isotonic saline
placebo (saline) is administered perineurally in all but the perineural group.
Other Name: Placebo

Active Comparator: High dose Ropivacaine
Ulnar nerve block 4ml ropivacaine 7.5mg/ml + 1ml isotonic saline (placebo) perineurally
Drug: Ropivacaine 7.5mg/ml
In the high dose ropivacaine group a ropivacaine concentration of 7.5mg/ml is used.
Other Name: Naropine

Drug: Isotonic saline
placebo (saline) is administered perineurally in all but the perineural group.
Other Name: Placebo




Primary Outcome Measures :
  1. Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between perineural dexmedetomidine and placebo [ Time Frame: 0-36 hours ]
    Duration of sensory nerve block measured by mechanical discrimination (pinprick) defined as time from block performance (removal of the needle) until the needle feels sharp again.

  2. Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between systemic dexmedetomidine and placebo [ Time Frame: 0-36 hours ]
    Duration of sensory nerve block measured by mechanical discrimination (pinprick) defined as time from block performance (removal of the needle) until the needle feels sharp again.

  3. Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between systemic dexmedetomidine and perineural dexmedetomidine [ Time Frame: 0-36 hours ]
    Duration of sensory nerve block measured by mechanical discrimination (pinprick) defined as time from block performance (removal of the needle) until the needle feels sharp again.


Secondary Outcome Measures :
  1. Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between high dose ropivacaine and placebo [ Time Frame: 0-36 hours ]
    Duration of sensory nerve block measured by mechanical discrimination (pinprick) defined as time from block performance (removal of the needle) until the needle feels sharp again.

  2. Difference in duration of sensory nerve block assessed by temperature discrimination between perineural dexmedetomidine and placebo [ Time Frame: 0-36 hours ]
    Duration of sensory nerve block measured by temperature discrimination defined as time from block performance (removal of the needle) until the stimulation with an alcohol swab feels cold again.

  3. Difference in duration of sensory nerve block assessed by temperature discrimination between systemic dexmedetomidine and placebo [ Time Frame: 0-36 hours ]
    Duration of sensory nerve block measured by temperature discrimination defined as time from block performance (removal of the needle) until the stimulation with an alcohol swab feels cold again.

  4. Difference in duration of sensory nerve block assessed by temperature discrimination between systemic dexmedetomidine and perineural dexmedetomidine [ Time Frame: 0-36 hours ]
    Duration of sensory nerve block measured by temperature discrimination defined as time from block performance (removal of the needle) until the stimulation with an alcohol swab feels cold again.

  5. Difference in duration of sensory nerve block assessed by temperature discrimination between high dose ropivacaine and placebo [ Time Frame: 0-36 hours ]
    Duration of sensory nerve block measured by temperature discrimination defined as time from block performance (removal of the needle) until the stimulation with an alcohol swab feels cold again.

  6. Difference in duration of sensory nerve block assessed by pain during tonic heat stimulation between perineural dexmedetomidine and placebo [ Time Frame: 0-36 hours ]
    Duration of sensory nerve block measured by pain during tonic heat stimulation defined as time from block performance (removal of the needle) until a thermode heated to 45C for 30 seconds elicits a painful response again (VAS>0)

  7. Difference in duration of sensory nerve block assessed by pain during tonic heat stimulation between systemic dexmedetomidine and placebo [ Time Frame: 0-36 hours ]
    Duration of sensory nerve block measured by pain during tonic heat stimulation defined as time from block performance (removal of the needle) until a thermode heated to 45C for 30 seconds elicits a painful response again (VAS>0)

  8. Difference in duration of sensory nerve block assessed by pain during tonic heat stimulation between perineural dexmedetomidine and systemic dexmedetomidine [ Time Frame: 0-36 hours ]
    Duration of sensory nerve block measured by pain during tonic heat stimulation defined as time from block performance (removal of the needle) until a thermode heated to 45C for 30 seconds elicits a painful response again (VAS>0)

  9. Difference in duration of sensory nerve block assessed by pain during tonic heat stimulation between high dose ropivacaine and placebo [ Time Frame: 0-36 hours ]
    Duration of sensory nerve block measured by pain during tonic heat stimulation defined as time from block performance (removal of the needle) until a thermode heated to 45C for 30 seconds elicits a painful response again (VAS>0)

  10. Difference in duration of motor nerve block assessed by maximum voluntary isometric contraction between perineural dexmedetomidine and placebo [ Time Frame: 0-36 hours ]
    Duration of motor nerve block measured by maximum voluntary isometric contraction is defined as time from block performance (removal of the needle) until fifth finger abduction maximal voluntary isometric contraction (MVIC) > 75% of baseline value, or the participant indicates return of normal motor funktion.

  11. Difference in duration of motor nerve block assessed by maximum voluntary isometric contraction between systemic dexmedetomidine and placebo [ Time Frame: 0-36 hours ]
    Duration of motor nerve block measured by maximum voluntary isometric contraction is defined as time from block performance (removal of the needle) until fifth finger abduction maximal voluntary isometric contraction (MVIC) > 75% of baseline value, or the participant indicates return of normal motor funktion.

  12. Difference in duration of motor nerve block assessed by maximum voluntary isometric contraction between systemic dexmedetomidine and perineural dexmedetomidine [ Time Frame: 0-36 hours ]
    Duration of motor nerve block meassured by maximum voluntary isometric contraction is defined as time from block performance (removal of the needle) until fifth finger abduction maximal voluntary isometric contraction (MVIC) > 75% of baseline value, or the participant indicates return of normal motor funktion.

  13. Difference in duration of motor nerve block assessed by maximum voluntary isometric contraction between high dose ropivacaine and placebo [ Time Frame: 0-36 hours ]
    Duration of motor nerve block measured by maximum voluntary isometric contraction is defined as time from block performance (removal of the needle) until fifth finger abduction maximal voluntary isometric contraction (MVIC) > 75% of baseline value, or the participant indicates return of normal motor funktion.

  14. Difference in onset of sensory nerve block assessed by mechanical discrimination (pinprick) between perineural dexmedetomidine and placebo [ Time Frame: 0-36 hours ]
    Onset of sensory nerve block assessed by mechanical discrimination (pinprick) is defined as time from block performance (removal of the needle) until the needle stops feeling sharp.

  15. Difference in onset of sensory nerve block assessed by mechanical discrimination (pinprick) between systemic dexmedetomidine and placebo [ Time Frame: 0-36 hours ]
    Onset of sensory nerve block assessed by mechanical discrimination (pinprick) is defined as time from block performance (removal of the needle) until the needle stops feeling sharp.

  16. Difference in onset of sensory nerve block assessed by mechanical discrimination (pinprick) between perineural dexmedetomidine and systemic dexmedetomidine [ Time Frame: 0-36 hours ]
    Onset of sensory nerve block assessed by mechanical discrimination (pinprick) is defined as time from block performance (removal of the needle) until the needle stops feeling sharp.

  17. Difference in onset of sensory nerve block assessed by mechanical discrimination (pinprick) between high dose ropivacaine and placebo [ Time Frame: 0-36 hours ]
    Onset of sensory nerve block assessed by mechanical discrimination (pinprick) is defined as time from block performance (removal of the needle) until the needle stops feeling sharp.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants must understand the protocol fully and sign the written in-formed consent.
  • 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 cooperate in the trial.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03222323


Contacts
Layout table for location contacts
Contact: Jakob H Andersen, M.D. +4560610666 Jahea@regionsjaelland.dk
Contact: Ole Mathiesen, M.D. Ph.D. omat@regionsjaelland.dk

Locations
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Denmark
Department of Anesthesiology Zealand University Hospital Recruiting
Køge, Denmark, 4600
Contact: Jakob H Andersen, MD    004560610666    JAHEA@regionsjaelland.dk   
Principal Investigator: Jakob H Andersen, MD         
Sub-Investigator: Frederik Vilhelmsen         
Sub-Investigator: Anja Geisler         
Sponsors and Collaborators
Zealand University Hospital
Investigators
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Principal Investigator: Jakob H Andersen, M.D. Department of Anesthesiology, Zealand University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jakob Hessel Andersen, Anesthesiologist, Staff Specialist, Zealand University Hospital
ClinicalTrials.gov Identifier: NCT03222323    
Other Study ID Numbers: REG-158-2016
2016-004883-20 ( EudraCT Number )
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jakob Hessel Andersen, Zealand University Hospital:
volunteers
Additional relevant MeSH terms:
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Dexmedetomidine
Ropivacaine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics