The Effect of Local Anesthetic and Clonidine on the Cutaneous Silent Period During Spinal Anesthesia
Primary Purpose
Inguinal Hernia, Spinal Anesthesia
Status
Active
Phase
Phase 4
Locations
Croatia
Study Type
Interventional
Intervention
levobupivacaine
clonidine
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring levobupivacaine, nerve fibers, clonidine
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
Sites / Locations
- Clinical Hospital Dubrava
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
0.5% levobupivacaine with 0.015% clonidine
0.5% levobupivacaine with 0.9% saline
Arm Description
0.5% levobupivacaine 15 mg with 0.015% clonidine 50 mcg and 40% glucose 0.5 ml will be preformed as subarachnoid block
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Duration of motor block
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.
Duration of sensory block
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).
Full Information
NCT ID
NCT03121261
First Posted
April 11, 2017
Last Updated
November 19, 2022
Sponsor
University Hospital Dubrava
1. Study Identification
Unique Protocol Identification Number
NCT03121261
Brief Title
The Effect of Local Anesthetic and Clonidine on the Cutaneous Silent Period During Spinal Anesthesia
Official Title
The Effect of Local Anesthetic and Clonidine on the Cutaneous Silent Period During and After Spinal Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Dubrava
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Spinal Anesthesia
Keywords
levobupivacaine, nerve fibers, clonidine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
0.5% levobupivacaine with 0.015% clonidine
Arm Type
Experimental
Arm Description
0.5% levobupivacaine 15 mg with 0.015% clonidine 50 mcg and 40% glucose 0.5 ml will be preformed as subarachnoid block
Arm Title
0.5% levobupivacaine with 0.9% saline
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
levobupivacaine
Other Intervention Name(s)
chirocaine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
clonidine
Other Intervention Name(s)
catapressan
Intervention Description
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
Primary Outcome Measure Information:
Title
4 Item Duration of Latency and duration of the cutaneous silent period
Description
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
Time Frame
24 hours perioperative
Secondary Outcome Measure Information:
Title
Duration of motor block
Description
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.
Time Frame
24 hours perioperative
Title
Duration of sensory block
Description
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).
Time Frame
24 hours perioperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Clinical Hospital Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
12. IPD Sharing Statement
Citations:
PubMed Identifier
9152203
Citation
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.
Results Reference
background
PubMed Identifier
26025613
Citation
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.
Results Reference
background
PubMed Identifier
1718720
Citation
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.
Results Reference
result
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The Effect of Local Anesthetic and Clonidine on the Cutaneous Silent Period During Spinal Anesthesia
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