Is the duration of a nerve block prolonged by adding dexmedetomidine to the local anaesthetic among healthy volunteers.

Does perineural dexmedetomidine prolong the duration of an ulnar nerve block when controlling for possible systemic effects? - a randomized, blinded, placebo controlled, paired trial in healthy volunteers

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004883-20-DK

Enrollment

Registered

2016-12-08

Start date

2017-02-01

Completion date

Unknown

Last updated

2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy volunteers (treatment intended to improve regional anesthesia for orthopedic surgery) MedDRA version: 19.1 Level: LLT Classification code 10054711 Term: Postoperative pain System Organ Class: 100000004863

Interventions

Trade Name: Dexdor Product Name: Dexdor Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Perineural use T

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Participants must meet all of the following criteria in order to be included in the trial: • Age > 18 years • Participants must understand the protocol fully and sign the written in-formed consent. • ASA 1-2 • BMI > 18 to =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Participants meeting one or more of the following criteria cannot be in-cluded in the trial: • 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of the trial is to investigate whether dexmedetomidine used as an adjuvant to ropivacaine prolongs block duration compared to ropivacaine alone, and whether block duration is affected by the mode of dexmedetomidine administration. ;Secondary Objective: Not applicable;Primary end point(s): • Duration of sensory nerve block assessed by mechanical discrimination (pinprick) in groups A (perineural dexmedetomidine) , B (systemic dexmedetomidine) and C (placebo).;Timepoint(s) of evaluation of this end point: Duration is meassured every 30 minutes from block-performance (removal of the needle) until the swab feels cold again	—

Measure

Time frame

Main Objective: The purpose of the trial is to investigate whether dexmedetomidine used as an adjuvant to ropivacaine prolongs block duration compared to ropivacaine alone, and whether block duration is affected by the mode of dexmedetomidine administration. ;Secondary Objective: Not applicable;Primary end point(s): • Duration of sensory nerve block assessed by mechanical discrimination (pinprick) in groups A (perineural dexmedetomidine) , B (systemic dexmedetomidine) and C (placebo).;Timepoint(s) of evaluation of this end point: Duration is meassured every 30 minutes from block-performance (removal of the needle) until the swab feels cold again

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Secondary

Measure	Time frame
Secondary end point(s): 1. Duration of sensory nerve block assessed by mechanical discrimination (pinprick) in group D.. 2. Duration of sensory nerve block assessed by temperature discrimination in groups A,B,C and D. 3. Duration of sensory nerve block assessed by pain during tonic heat stimulation in groups A,B,C and D. 4. Duration of motor nerve block assessed by maximum voluntary isometric contraction in groups A,B,C and D. 5. Onset of sensory nerve block assessed by mechanical discrimination (pinprick) in groups A,B,C and D. Group A: Perineural dexmedetomidine Group B: Systemic dexmedetomidine Group C: Ropivacaine + placebo Group D: Highdose ropivacaine and placebo.;Timepoint(s) of evaluation of this end point: Duration is meassured every 30 minutes from block-performance (removal of the needle) until normal sensation and MVIC>75% Onset is meassured every 5 minutes post block (removal of the needle) until ceased sensation	—

Measure

Time frame

Secondary end point(s): 1. Duration of sensory nerve block assessed by mechanical discrimination (pinprick) in group D.. 2. Duration of sensory nerve block assessed by temperature discrimination in groups A,B,C and D. 3. Duration of sensory nerve block assessed by pain during tonic heat stimulation in groups A,B,C and D. 4. Duration of motor nerve block assessed by maximum voluntary isometric contraction in groups A,B,C and D. 5. Onset of sensory nerve block assessed by mechanical discrimination (pinprick) in groups A,B,C and D. Group A: Perineural dexmedetomidine Group B: Systemic dexmedetomidine Group C: Ropivacaine + placebo Group D: Highdose ropivacaine and placebo.;Timepoint(s) of evaluation of this end point: Duration is meassured every 30 minutes from block-performance (removal of the needle) until normal sensation and MVIC>75% Onset is meassured every 5 minutes post block (removal of the needle) until ceased sensation

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Countries

Denmark

Contacts

Public ContactJakob Hessel Andersen

Zealand University Hospital

Jahea@regionsjaelland.dk+4560610666

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026