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NCT Number: NCT03121261

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

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.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Anesthesia

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Hospital Dubrava

Zagreb, 10000, Croatia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: chirocaine

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

Other names: catapressan

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University Hospital Dubrava

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2027
Study completion
2028
First posted
Apr 20, 2017
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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