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Perineural Dexmedetomidine for Ulnar Nerve Block.

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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

Tracking Information
First Submitted Date  ICMJE July 17, 2017
First Posted Date  ICMJE July 19, 2017
Last Update Posted Date July 31, 2017
Actual Study Start Date  ICMJE July 17, 2017
Estimated Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 17, 2017)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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)
  • 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)
  • 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)
  • 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)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 17, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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)
  • 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)
  • 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)
  • 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)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perineural Dexmedetomidine for Ulnar Nerve Block.
Official Title  ICMJE Does Perineural Dexmedetomidine Prolong the Duration of an Ulnar Nerve Block When Controlling for Possible Systemic Effects?
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
  • Drug: Ropivacaine 7.5mg/ml
    In the high dose ropivacaine group a ropivacaine concentration of 7.5mg/ml is used.
    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
Study Arms  ICMJE
  • Experimental: Perineural dexmedetomidine
    Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml 100ug/ml dexmedetomidine perineurally
    Interventions:
    • Drug: Dexmedetomidine perineurally
    • Drug: Ropivacaine 5mg/ml
  • 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)
    Interventions:
    • Drug: Ropivacaine 5mg/ml
    • Drug: Dexmedetomidine systemically
    • Drug: Isotonic saline
  • Placebo Comparator: Placebo
    Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml isotonic saline (placebo) perineurally
    Interventions:
    • Drug: Ropivacaine 5mg/ml
    • Drug: Isotonic saline
  • Active Comparator: High dose Ropivacaine
    Ulnar nerve block 4ml ropivacaine 7.5mg/ml + 1ml isotonic saline (placebo) perineurally
    Interventions:
    • Drug: Ropivacaine 7.5mg/ml
    • Drug: Isotonic saline
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 17, 2017)
22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2018
Estimated Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03222323
Other Study ID Numbers  ICMJE REG-158-2016
2016-004883-20 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Jakob Hessel Andersen, Zealand University Hospital
Study Sponsor  ICMJE Zealand University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jakob H Andersen, M.D. Department of Anesthesiology, Zealand University Hospital
PRS Account Zealand University Hospital
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP