Spinal Anaesthesia With Levobupivacaine 0.5% and Ropivacaine 0.75% for Lower Limb Orthopaedic Surgery

Study Overview
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Brief Summary
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The purpose of this study is to compare the effects of two intrathecally administered drugs:0.5% levobupivacaine and0.75%Ropivacaine in spinal anesthesia

Detailed Description
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Bupivacaine is a highly cardiotoxic drug and also produces prolonged motor blockade.The newer drugs levobupivacaine and ropivacaine being comparatively less cardio and neurotoxic are preferred now a days.So, we conducted this prospective, randomized double blind study with an aim of comparing the efficacy and characteristics of these drugs.

Official Title
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A Comparative Study Between Levobupivacaine 0.5% and Ropivacaine 0.75% in Patients Undergoing Spinal Anaesthesia for Lower Limb Orthopaedic Surgery.

Conditions
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Lower Limb Surgery

Intervention / Treatment
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* Drug: Levobupivacaine
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) class I & II patients of either sex Age between 18-60 years Exclusion Criteria: Patient's refusal. Patients who have contraindications to spinal anaesthesia / Local anaesthetic drugs. Patients having h/o diabetes, neurological and musculoskeletal diseases.

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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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levobupivacaine 0.5%<br>intrathecal administration of 15 mg of Levobupivacaine 0.5% | Drug: Levobupivacaine<br>* Comparison of Equipotent doses<br>* Other names: Chirocaine;|
| Active Comparator: Ropivacaine 0.75%<br>intrathecal administration of 22.5 mg of Ropivacaine 0.75% | Drug: Ropivacaine<br>* Comparison of equipotent doses<br>* Other names: Naropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Analgesia | Defined as time for first analgesic request by the patient | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of Sensory Block at T10 | level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned. | 30 minutes | 
| Median Maximum Level of Sensory Blockade | level of sensory block was assessed every 5 minutes till the loss of sensation to pinprick, using 22-guage hypodermic needle with 2mm protrusion through guard. Assessments continued at 30 min intervals following the completion of surgery until normal sensation returned. | 8 hours | 
| Time to Maximum Cephalic Spread of Sensory Block |  | 8 hours | 
| Onset of Motor Block to Bromage3 | Motor block in the lower limbs was graded according to the modified Bromage scale (Grade 0 = No motor block, Grade 1 = Inability to raise extended leg, able to move knees and feet, Grade 2 = Inability to raise extended leg and move knee, able to move feet, Grade 3 = Complete motor block of the lower limbs). Thereafter, It was performed every 5 minutes till the attainment of MB grade 3 followed by every 30 minutes until complete recovery (MB grade0). | 8 hours | 
| Duration of Motor Block | Time when the Bromage score will be back to zero | 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subarachnoid block, intrathecal, spinal anesthesia, isobaric, levobupivacaine, ropivacaine