Perineural Dexmedetomidine for Ulnar Nerve Block.

NCT03222323 | Unknown Phase 2

• 2 other identifiers: REG-158-20162016-004883-20
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

volunteers

Outcome Measures

Primary Outcomes (3)

• Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between perineural dexmedetomidine and placebo

  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

  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

  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 Outcomes (17)

• Difference in duration of sensory nerve block assessed by mechanical discrimination (pinprick) between high dose ropivacaine and placebo

  0-36 hours

• Difference in duration of sensory nerve block assessed by temperature discrimination between perineural dexmedetomidine and placebo

  0-36 hours

• Difference in duration of sensory nerve block assessed by temperature discrimination between systemic dexmedetomidine and placebo

  0-36 hours

• Difference in duration of sensory nerve block assessed by temperature discrimination between systemic dexmedetomidine and perineural dexmedetomidine

  0-36 hours

• Difference in duration of sensory nerve block assessed by temperature discrimination between high dose ropivacaine and placebo

  0-36 hours

Study Arms (4)

Perineural dexmedetomidine

EXPERIMENTAL

Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml 100ug/ml dexmedetomidine perineurally

Drug: Dexmedetomidine perineurally; Drug: Ropivacaine 5mg/ml

Systemic dexmedetomidine

ACTIVE COMPARATOR

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; Drug: Dexmedetomidine systemically; Drug: Isotonic saline

Placebo

PLACEBO COMPARATOR

Ulnar nerve block 4ml ropivacaine 5mg/ml + 1ml isotonic saline (placebo) perineurally

Drug: Ropivacaine 5mg/ml; Drug: Isotonic saline

High dose Ropivacaine

ACTIVE COMPARATOR

Ulnar nerve block 4ml ropivacaine 7.5mg/ml + 1ml isotonic saline (placebo) perineurally

Drug: Ropivacaine 7.5mg/ml; Drug: Isotonic saline

Interventions

Dexmedetomidine perineurally DRUG

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.

Also known as: Dexdor

Perineural dexmedetomidine

Ropivacaine 5mg/ml DRUG

Ropivacaine is used in 5mg/ml in the perineural, systemic and placebo nerve blocks.

Also known as: Naropine

Perineural dexmedetomidine; Placebo; Systemic dexmedetomidine

Ropivacaine 7.5mg/ml DRUG

In the high dose ropivacaine group a ropivacaine concentration of 7.5mg/ml is used.

Also known as: Naropine

High dose Ropivacaine

Dexmedetomidine systemically DRUG

Dexmedetomidine administered perineurally on one side is absorbed and redistributed systemically and will influence the opposite ulnar nerve block systemically.

Also known as: dexdor

Systemic dexmedetomidine

Isotonic saline DRUG

placebo (saline) is administered perineurally in all but the perineural group.

Also known as: Placebo

High dose Ropivacaine; Placebo; Systemic dexmedetomidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• \. degree heart block
• Sick sinus node.
• For fertile women a positive urine HCG

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Department of Anesthesiology Zealand University Hospital

Køge, 4600, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 30679332 DERIVED

MeSH Terms

Interventions

Dexmedetomidine; Ropivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jakob H Andersen, M.D.

  Department of Anesthesiology, Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jakob H Andersen, M.D.

CONTACT

+4560610666; Jahea@regionsjaelland.dk

Ole Mathiesen, M.D. Ph.D.

CONTACT

omat@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist, Staff Specialist

Model Details: The participants will attend two trial days and receive two treatments on each trial days

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 19, 2017
• Study Start: July 17, 2017
• Primary Completion: January 1, 2018
• Study Completion: April 1, 2018
• Last Updated: July 31, 2017

Record last verified: 2017-07

Locations

DK (1)