The Effect of Different Degree of Temperature on Levobupivacaine Spinal Anesthesia

Study Overview
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Brief Summary
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This study will be conducted to evaluate the effect of different temperature on the spinal anesthesia characteristics and incidence of complications

Detailed Description
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Regional anesthesia techniques are also superior to systemic opioids agents with regard the analgesic profile and adverse effects .Spinal anesthesia is the most commonly used technique due to its unmatchable reliability,simplicity and cost-effectiveness. It provides a fast and effective onset of sensory and motor block, excellent muscle relaxation and prolonged postoperative analgesia . Bupivacaine is commonly used local anesthetics because of its long duration of action and combined motor and sensory blockade. However, it has many drawbacks .It has a high propensity to cause hypotension and bradycardia. There is also cardiac toxicity.Levobupivacaine is an attractive alternative to bupivacaine because of the lower affinity for cardiac sodium channels and reducing the risk of cardiac toxicity.Moreover ,the isobaric levobupivacaine had more stability in cerebrospinal fluid and thus lead to more predictable drug spread, decreasing the incidence of hypotension and bradycardia. But its main disadvantage is the delayed onset . A number of strategies have been used to hasten the onset of local anesthesia .The addition of fentanyl mixtures of local anesthetics and alkalization of the local anesthetics all shorten the onset time of sensory block. Recently the warming of the anesthetic agents (namely, lidocaine and bupivacaine) to 37° C hastens the sensory block in various surgical settings . Up till now there is no study suggestive of any appropriate degree of temperature as adjuvant .Hence the present study will be conducted to evaluate the effect of different temperature on spinal anesthesia characteristics and the incidence its complication

Official Title
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The Influence of Different Degrees of Levobupivacaine Temperature on Spinal Anesthesia in Orthopedic Surgeries: Prospective Randomized Study

Conditions
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Spinal Anesthetic Toxicity

Intervention / Treatment
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* Drug: Levobupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA-I or II Exclusion Criteria: patient refusal; Any known hypersensitivity or contraindication to levobupivacaine pregnancy bleeding disorders local skin infections. Sepsis at the site of injection Coagulation abnormality Psychiatric disorders

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: levobupivacaine at ( 23˚C)<br>Levobupivacine hydrochloride at ( 23˚C) will be received 3.5 ml levobupivacaine at the operating room temperature 23˚C will be administered | Drug: Levobupivacaine<br>* Drug: levobupivacaine at room temperature ( 23˚C) and second group levobupivacaine warmed to the (30˚C) while the third group levobupivacaine warmed to the body temperature (37˚C)<br>* Other names: Chirocaine;|
| Active Comparator: Warm levobupivacaine at (30˚C)<br>Drug:Warm levobupivacaine hydrochlorid (3.5 ml) will be warmed at (30˚C) for 24 hours. The empty syringes and needles ,in their packaging, will be held at the same temperature before the spinal anesthesia | Drug: Levobupivacaine<br>* Drug: levobupivacaine at room temperature ( 23˚C) and second group levobupivacaine warmed to the (30˚C) while the third group levobupivacaine warmed to the body temperature (37˚C)<br>* Other names: Chirocaine;|
| Active Comparator: Warm levobupivacaine at (37˚C)<br>Drug:Warm levobupivacaine hydrochlorid (3.5 ml) will be warmed at (37˚C) for 24 hours. The empty syringes and needles ,in their packaging, will be held at the same temperature before the spinal anesthesia | Drug: Levobupivacaine<br>* Drug: levobupivacaine at room temperature ( 23˚C) and second group levobupivacaine warmed to the (30˚C) while the third group levobupivacaine warmed to the body temperature (37˚C)<br>* Other names: Chirocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset of sensory block | Defined as the time interval between the end of spinal anesthesia injection and the loss of sensation to pin prick (sensory score=1) | For 10 minutes following the spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the onset of motor block | Defined as the time interval between the end of spinal anesthesia and (motor score=1) within both lower limbs | For 10 minutes following the injection of spinal anesthesia | 
| Duration of sensory block | Defined as the interval between the end of spinal anesthesia and complete end of sensory block (sensory score=2) | For 24 hours after the spinal anesthesia | 
| Duration of motor block | Defined as the interval between the end of spinal anesthesia and complete recovery of normal motor function (score=0) | For 24 hours after the spinal anesthesia | 
| Post spinal shivering | Post spinal shivering will be graded using a scale ( score 0=no shivering ,score 1= no visible muscle activity ,but one or more of piloerection, score 2=muscular activity in only one muscle group,score 3=moderate muscular activity in more than one muscle group but not generalized shaking ,score 4=violent muscular activity that involves entire body ) | for 24 hours after spinal anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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levobupivacaine,spinal anesthesia ,temperature