Clinical trial

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

Name

070219812014

Description

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.

Trial arms

Trial start

2017-05-01

Estimated PCD

2025-09-01

Trial end

2026-10-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

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

Arms:

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

Other names:

chirocaine

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

Arms:

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

Other names:

catapressan

Size

Primary endpoint

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

24 hours perioperative

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2023-12-12

1 organization

2 products

2 indications

Organization

University Hospital Dubrava

Product

Indication

Indication

Product