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

NCT03121261 | Active Not Recruiting Phase 4

• 1 other identifier: 070219812014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia; Spinal Anesthesia

Keywords

levobupivacaine; nerve fibers; clonidine

Outcome Measures

Primary Outcomes (1)

• 4 Item Duration of Latency and duration of the cutaneous silent period

  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

  24 hours perioperative

Secondary Outcomes (2)

• Duration of motor block

  24 hours perioperative

• Duration of sensory block

  24 hours perioperative

Study Arms (2)

0.5% levobupivacaine with 0.015% clonidine

EXPERIMENTAL

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; Drug: clonidine

0.5% levobupivacaine with 0.9% saline

ACTIVE COMPARATOR

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; Drug: clonidine

Interventions

levobupivacaine DRUG

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

Also known as: chirocaine

0.5% levobupivacaine with 0.015% clonidine; 0.5% levobupivacaine with 0.9% saline

clonidine DRUG

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

Also known as: catapressan

0.5% levobupivacaine with 0.015% clonidine; 0.5% levobupivacaine with 0.9% saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA one and two status BMI 18,5 to 24

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Dubrava: lead

Study Sites (1)

Clinical Hospital Dubrava

Zagreb, 10000, Croatia

Location

Related Publications (3)

• Inghilleri M, Cruccu G, Argenta M, Polidori L, Manfredi M. Silent period in upper limb muscles after noxious cutaneous stimulation in man. Electroencephalogr Clin Neurophysiol. 1997 Apr;105(2):109-15. doi: 10.1016/s0924-980x(97)96579-6.

  PMID: 9152203 BACKGROUND

• Mota IA, Fernandes JB, Cardoso MN, Sala-Blanch X, Kofler M, Valls-Sole J. Temporal profile of the effects of regional anesthesia on the cutaneous reflexes of foot muscles. Exp Brain Res. 2015 Sep;233(9):2587-96. doi: 10.1007/s00221-015-4329-2. Epub 2015 May 30.

  PMID: 26025613 BACKGROUND

• Uncini A, Kujirai T, Gluck B, Pullman S. Silent period induced by cutaneous stimulation. Electroencephalogr Clin Neurophysiol. 1991 Oct;81(5):344-52. doi: 10.1016/0168-5597(91)90023-q.

  PMID: 1718720 RESULT

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Levobupivacaine; Clonidine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurology Specialist

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 20, 2017
• Study Start: May 1, 2017
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

CR (1)