Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia

Study Overview
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Brief Summary
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This study compares the clinical efficacy of newer local anaesthetic drugs Levobupivacaine and Ropivacaine with Bupivacaine in lumbar epidural anaesthesia for hip surgeries.

Detailed Description
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Some of the most common day care surgeries are hip surgeries, in which local anaesthetic agents can be used via epidural route for both intra-op and post-op analgesia. Among the drugs used nowadays are Lignocaine, Bupivacaine, Levobupivacaine and Ropivacaine.However Bupivacaine usage is not free from side effects. The claimed benefits of both Levobupivacaine and Ropivacaine are reduced cardiac toxicity on overdose and more specific effects on sensory rather than motor nerve fibres. Ropivacaine, an analog of Mepivacaine, is one of the long acting amide anaesthetic agent similar to Bupivacaine in chemical structure and anaesthetic function. It is a first enantiomer-specific compound, which has a reduced risk of cardio toxicity, neuro toxicity and rapid recovery of motor function. Levobupivacaine is the pure S (-)-enantiomer of Bupivacaine, and in recent year has emerged as a safer alternative for regional anaesthesia than its racemic parent.

Official Title
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Comparative Evaluation of Newer Congeners i.e. Levobupivacaine and Ropivacaine With Bupivacaine, in Lumbar Epidural Anaesthesia for Hip Surgeries

Conditions
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Pain Insensitivity, Congenital

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Levobupivacaine
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA Grade I and II patients of either sex Age 18-60 years Undergoing various hip surgeries under lumbar epidural anesthesia Exclusion Criteria: Refusal for epidural ASA-III&IV Head injury Psychiatric disease Known allergic to test drugs Major systemic disease Any analgesia with in past 24 hours

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: Bupivacaine & Levobupivacaine<br>Bupivacaine 15 ml 0.5% and Levobupivacaine 15 ml 0.5% in epidural route before surgery | Drug: Bupivacaine<br>* Local anesthetic<br>* Other names: Sensorcaine;Drug: Levobupivacaine<br>* Local anesthetic<br>* Other names: Levo-anawin;|
| Active Comparator: Bupivacaine & Ropivacaine<br>Bupivacaine 15 ml 0.5% and Ropivacaine 15 ml 0.75% in epidural route before surgery | Drug: Bupivacaine<br>* Local anesthetic<br>* Other names: Sensorcaine;Drug: Ropivacaine<br>* Local anesthetic<br>* Other names: Ropin;|
| Active Comparator: Ropivacaine & Levobupivacaine<br>Ropivacaine 15 ml 0.75% and Levobupivacaine 15 ml 0.5% in epidural route before surgery | Drug: Levobupivacaine<br>* Local anesthetic<br>* Other names: Levo-anawin;Drug: Ropivacaine<br>* Local anesthetic<br>* Other names: Ropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of sensory block | Time to achieve sensory block up to tenth thoracic dermatome | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for 2 segment regression of sensory block | Time for regression of sensory block 2 segments lower than maximum blocked dermatome | 90 minutes | 
| Time to achieve maximum motor block | Time to achieve motor block of modified Bromage score | 45 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar epidural anaesthesia