Perineural Dexmedetomidine for Ulnar Nerve Block.

July 26, 2017 updated by: Jakob Hessel Andersen, Zealand University Hospital

Does Perineural Dexmedetomidine Prolong the Duration of an Ulnar Nerve Block When Controlling for Possible Systemic Effects?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
      • Køge, Denmark, 4600
        • Recruiting
        • Department of Anesthesiology Zealand University Hospital
        • Contact:
        • Principal Investigator:
          • Jakob H Andersen, MD
        • Sub-Investigator:
          • Frederik Vilhelmsen
        • Sub-Investigator:
          • Anja Geisler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Dexdor
Drug: Ropivacaine 5mg/ml
Ropivacaine is used in 5mg/ml in the perineural, systemic and placebo nerve blocks.
Other Names:
  • 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 Names:
  • 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 Names:
  • dexdor
Drug: Isotonic saline
placebo (saline) is administered perineurally in all but the perineural group.
Other Names:
  • 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 Names:
  • Naropine
Drug: Isotonic saline
placebo (saline) is administered perineurally in all but the perineural group.
Other Names:
  • Placebo
Active Comparator: High dose Ropivacaine
Ulnar nerve block 4ml ropivacaine 7.5mg/ml + 1ml isotonic saline (placebo) perineurally
Drug: Isotonic saline
placebo (saline) is administered perineurally in all but the perineural group.
Other Names:
  • Placebo
Drug: Ropivacaine 7.5mg/ml
In the high dose ropivacaine group a ropivacaine concentration of 7.5mg/ml is used.
Other Names:
  • Naropine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
0-36 hours
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.
0-36 hours
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.
0-36 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
0-36 hours
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.
0-36 hours
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.
0-36 hours
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.
0-36 hours
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.
0-36 hours
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)
0-36 hours
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)
0-36 hours
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)
0-36 hours
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)
0-36 hours
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.
0-36 hours
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.
0-36 hours
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.
0-36 hours
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.
0-36 hours
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.
0-36 hours
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.
0-36 hours
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.
0-36 hours
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.
0-36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zealand University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jakob H Andersen, M.D., Department of Anesthesiology, Zealand University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 17, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REG-158-2016
  • 2016-004883-20 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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