NCT02488473

Brief Summary

Brief Summary: The aim of this trial is to investigate if dexmedetomidine prolongs the duration of an adductor canal block. By using healthy volunteers the investigators can perform a bilateral adductor canal block 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2 healthy

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_2 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 5, 2016

Status Verified

August 1, 2015

Enrollment Period

1 month

First QC Date

June 30, 2015

Last Update Submit

January 4, 2016

Conditions

Healthy

Keywords

Volunteers

Outcome Measures

Primary Outcomes (1)

  • Difference in duration of sensory block between dexmedetomidine and placebo assessed as cold sensation with an alcohol swab

    Duration is defined as time from block performance until recovery of cold sensation to an alcohol swab, assessed every hour post-block (and every half hour when pain scores during the tonic heat stimulation test is above 0) Time for sleep will be provided.

    0-36 hours

Secondary Outcomes (5)

  • Difference between dexmedetomidine and placebo in the duration of a sensory block assessed by pin-prick

    0-36 hours

  • Difference between dexmedetomidine and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test

    0-36 hours

  • Difference between dexmedetomidine and placebo in the duration of a sensory block assessed as warmth detection threshold

    0-36 hours

  • Difference between dexmedetomidine and placebo in the duration of a sensory block assessed as heat pain detection threshold

    0-36 hours

  • Difference in maximum pain scores between dexmedetomidine and placebo during block and after recovery of normal sensation.

    0-36 hours

Study Arms (2)

Ropivacaine + Dexmedetomidine

EXPERIMENTAL

Adductor Canal Block 20 ml Ropivacaine 5mg/ml + 1 ml Dexmedetomidine 100ug/ml

Drug: DexmedetomidineDrug: Ropivacaine

Ropivacaine + Placebo

PLACEBO COMPARATOR

Adductor Canal Block 20 ml Ropivacaine 5mg/ml + 1 ml Saline

Drug: RopivacaineDrug: Isotonic Saline

Interventions

DexmedetomidineDRUG

100 ug dexmedetomidine added to the ropivacaine nerveblock

Also known as: Dexdor
Ropivacaine + Dexmedetomidine
RopivacaineDRUG

20 ml Ropivacaine 5mg/ml

Ropivacaine + DexmedetomidineRopivacaine + Placebo
Isotonic SalineDRUG

Placebo

Ropivacaine + Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists class 1
  • Body Mass Index 18-30

You may not qualify if:

  • Allergy to study medication
  • Earlier trauma or surgery to lower limb
  • Diabetes Mellitus
  • Alcohol or drug abuse
  • Daily intake of opioids or steroids last 4 weeks
  • Daily intake of any analgesics last 48 hours Heart block Sick sinus node.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology Koege Hospital

Koege, 4600, Denmark

Location

MeSH Terms

Interventions

DexmedetomidineRopivacaineSodium Chloride

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jakob H Andersen, MD

    Department of Anesthesiology Koege Hospital

    PRINCIPAL INVESTIGATOR

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

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 2, 2015

Study Start

August 1, 2015

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

January 5, 2016

Record last verified: 2015-08

Locations

DK(1)