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Trial record 9 of 326 for:    clonidine

The Effect of Local Anesthetic and Clonidine on the Cutaneous Silent Period During Spinal Anesthesia

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ClinicalTrials.gov Identifier: NCT03121261
Recruitment Status : Active, not recruiting
First Posted : April 20, 2017
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Sandra Graf Zupcic, University Hospital Dubrava

Brief Summary:
The cutaneous silent period is a non-invasive technique that gives insight into the function of thin A delta fibers and as such can be a complement to conventional electrophysiological methods used to study the peripheral nerves. Clonidine is a selective partial agonist of the alpha-2 receptors which, added intrathecally to levobupivacaine, enhances the effect of a local anesthetic, prolongs sensory and motor block during local anesthesia and extends the length of post-operative analgesia. It is believed that clonidine achieves this effect by activating the postsynaptic alpha-2 receptors in the gelatine substance of the spinal cord and blocking the conduction of A-delta and C fibers. The aim of the study is to examine functional changes of Aδ - fibers during the application of spinal anesthesia by measuring the cutaneous slinet period and compare the effect of intrathecal administration of a combination of local anesthetic and clonidine in the quiet skin period in relation to the application of local anesthetic only.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Spinal Anesthesia Drug: levobupivacaine Drug: clonidine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Local Anesthetic and Clonidine on the Cutaneous Silent Period During and After Spinal Anesthesia
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 0.5% levobupivacaine with 0.015% clonidine
0.5% levobupivacaine 15 mg with 0.015% clonidine 50 mcg and 40% glucose 0.5 ml will be preformed as subarachnoid block
Drug: levobupivacaine
Comparing: 0.5% levobupivacaine 15 milligrams (mg) , 0.015% clonidine 50 micrograms (mcg) and 40% glucose 0.5 milliliters (ml) with 0.5 levobupivacaine 15 mg , 0.9% saline 0.33 ml and 40% glucose 0.5 ml
Other Name: chirocaine

Drug: clonidine
Comparing: 0.5% levobupivacaine 15 mg , 0.015% clonidine 50 mcg and 40% glucose 0.5 ml with 0.5 levobupivacaine 15 mg , 0.9% saline 0.33 ml and 40% glucose 0.5 ml
Other Name: catapressan

Active Comparator: 0.5% levobupivacaine with 0.9% saline
0.5% levobupivacaine 15 mg with 0.33 ml of 0.9% saline and 40% glucose 0.5 ml will be preformed as subarachnoid block
Drug: levobupivacaine
Comparing: 0.5% levobupivacaine 15 milligrams (mg) , 0.015% clonidine 50 micrograms (mcg) and 40% glucose 0.5 milliliters (ml) with 0.5 levobupivacaine 15 mg , 0.9% saline 0.33 ml and 40% glucose 0.5 ml
Other Name: chirocaine

Drug: clonidine
Comparing: 0.5% levobupivacaine 15 mg , 0.015% clonidine 50 mcg and 40% glucose 0.5 ml with 0.5 levobupivacaine 15 mg , 0.9% saline 0.33 ml and 40% glucose 0.5 ml
Other Name: catapressan




Primary Outcome Measures :
  1. 4 Item Duration of Latency and duration of the cutaneous silent period [ Time Frame: 24 hours perioperative ]
    Duration of latency and duration of the cutaneous silent (msec) period before subarahnoid block, after regression of motor block, sixth hour of intrathecal administration, 24 hours after intrathecal administration


Secondary Outcome Measures :
  1. Duration of motor block [ Time Frame: 24 hours perioperative ]
    The duration of motor block and its regression will be monitored by Bromage scale:0- Bromage patient can perform movements in the hip, knee and foot. Bromage 1-patient can not perform movements in the hip, but can flexes the knee and move the foot, Bromage 2- patient can not perform movements in the hip and knee, but can move a foot. Bromage 3- patient can not perform movements in the hip, knee nor move the foot. The time of intrathecal levobupivacaine solution or levobupivacaine and clonidine solution is considered to be time zero.

  2. Duration of sensory block [ Time Frame: 24 hours perioperative ]
    The time needed for the regression of sensory block in two dermatome will be measured; the time (min) required for a regression in the S1 dermatome, the time required to restore motor functions in Bromage 0 and the duration of analgesia(min).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

ASA one and two status BMI 18,5 to 24

Exclusion Criteria:

Coagulation disorders Polyneuropathy Diabetes mellitus Alcoholism Systemic inflammatory and malignant diseases Stroke


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): NCT03121261


Locations
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Croatia
Clinical Hospital Dubrava
Zagreb, Croatia, 10000
Sponsors and Collaborators
University Hospital Dubrava

Publications of Results:
Other Publications:
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Responsible Party: Sandra Graf Zupcic, Neurology Specialist, University Hospital Dubrava
ClinicalTrials.gov Identifier: NCT03121261     History of Changes
Other Study ID Numbers: 070219812014
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sandra Graf Zupcic, University Hospital Dubrava:
levobupivacaine
nerve fibers
clonidine
Additional relevant MeSH terms:
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Clonidine
Hernia, Inguinal
Hernia
Pathological Conditions, Anatomical
Hernia, Abdominal
Anesthetics
Levobupivacaine
Anesthetics, Local
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