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Trial record 28 of 326 for:    clonidine

Does Perineural Clonidine Prolong Duration of a Nerve Block?

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ClinicalTrials.gov Identifier: NCT02444559
Recruitment Status : Completed
First Posted : May 14, 2015
Last Update Posted : July 1, 2015
Sponsor:
Information provided by (Responsible Party):
Jakob Hessel Andersen, Zealand University Hospital

Brief Summary:
The aim of this trial is to investigate if clonidine 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 clonidine/dexmedetomidine as an adjunct to a local anaesthetic prolongs the duration of a peripheral nerve block by a peripheral mechanism.

Condition or disease Intervention/treatment Phase
Healthy Drug: Ropivacaine 20ml 5mg/ml+ Clonidine 150ug Drug: Ropivacaine 20ml 5mg/ml+ Placebo Phase 2

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 clonidine to the local anaesthetic ropivacaine in peripheral nerve blocks.

The prolonging effect of using clonidine as adjuncts 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 clonidine will be investigated using the adductor canal block. This is a nerve block that besides being efficient as pain treatment after knee surgery, is primarily sensory, and therefore augments mobilization after total knee arthroplasty.

Method:

On the trial day the volunteers will receive bilateral adductor canal blocks. In one thigh they will receive the local anaesthetic ropivacaine 20ml 5mg/ml and placebo (saline) and in the other thigh ropivacaine 20ml 5mg/ml and Clonidine 150μg. The allocation is blinded to volunteer and investigator.

The duration of the nerve block will be measured by five different tests: Temperature test, Pinprick, Pain during tonic heat stimulation, Warmth detection threshold and pain detection threshold. All tests are validated within pain research.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Perineural Clonidine Prolong the Duration of an Adductor Canal Block When Controlling for a Systemic Effect? - A Randomised Paired Trial in Healthy Volunteers.
Study Start Date : May 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ropivacaine+Clonidine
Adductor Canal Block Ropivacaine 20ml 5mg/ml+ Clonidine 150ug
Drug: Ropivacaine 20ml 5mg/ml+ Clonidine 150ug
Placebo Comparator: Ropivacaine+Placebo
Adductor Canal Block Ropivacaine 20ml 5mg/ml+ saline
Drug: Ropivacaine 20ml 5mg/ml+ Placebo



Primary Outcome Measures :
  1. Difference in duration of sensory block between clonidine and placebo assessed as cold sensation with an alcohol swab [ Time Frame: 0-36 hours ]
    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.


Secondary Outcome Measures :
  1. Difference between Clonidine and placebo in the duration of a sensory block assessed by pin-prick [ Time Frame: 0-36 hours ]
    Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block Time for sleep will be provided.

  2. Difference between clonidine and placebo in the duration of a sensory block assessed as maximum pain during a tonic heat stimulation test [ Time Frame: 0-36 hours ]
    Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block Time for sleep will be provided. Recovery of normal sensation is defined as VAS pain scores ± 10 mm of the pre-block value.

  3. Difference between clonidine and placebo in the duration of a sensory block assessed as warmth detection threshold [ Time Frame: 0-36 hours ]
    Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block Time for sleep will be provided. Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.

  4. Difference between clonidine and placebo in the duration of a sensory block assessed as heat pain detection threshold [ Time Frame: 0-36 hour ]
    Duration is defined as time from block performance until recovery of normal sensation, assessed on the hour post block. Time for sleep will be provided. Recovery of normal sensation is defined as detection thresholds of ± 2 degrees C of the pre-block value.

  5. Difference in maximum pain scores between clonidine and placebo during block and after recovery of normal sensation. [ Time Frame: 0-36 hours ]
    Pain scores during a tonic heat stimulation will be compared every hour post block and 1 h after pain scores have returned to the pre-block values. Time for sleep will be provided.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444559


Locations
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Denmark
Department of Anesthesiology Koege Hospital
Koege, Denmark, 4600
Sponsors and Collaborators
Zealand University Hospital
Investigators
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Principal Investigator: Jakob H Andersen, MD Department of Anesthesiology Koege Hospital

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Responsible Party: Jakob Hessel Andersen, Anesthesiologist, Staff specialist, Zealand University Hospital
ClinicalTrials.gov Identifier: NCT02444559     History of Changes
Other Study ID Numbers: SM1-JH-14
2014-005640-18 ( EudraCT Number )
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: July 1, 2015
Last Verified: June 2015
Keywords provided by Jakob Hessel Andersen, Zealand University Hospital:
Volunteers
Additional relevant MeSH terms:
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Clonidine
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action