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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine & Levobupivacaine | Active Comparator | Bupivacaine 15 ml 0.5% and Levobupivacaine 15 ml 0.5% in epidural route before surgery |
|
| Bupivacaine & Ropivacaine | Active Comparator | Bupivacaine 15 ml 0.5% and Ropivacaine 15 ml 0.75% in epidural route before surgery |
|
| Ropivacaine & Levobupivacaine | Active Comparator | Ropivacaine 15 ml 0.75% and Levobupivacaine 15 ml 0.5% in epidural route before surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Local anesthetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Onset of sensory block | Time to achieve sensory block up to tenth thoracic dermatome | 30 minutes |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geeta Bhandari, M.D. | Professor and Head of the department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Government Medical College | Haldwani | Uttarakhand | 263139 | India |
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| ID | Term |
|---|---|
| D000699 | Pain Insensitivity, Congenital |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D030342 | Genetic Diseases, Inborn |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077554 | Levobupivacaine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Levobupivacaine | Drug | Local anesthetic |
|
|
| Ropivacaine | Drug | Local anesthetic |
|
|
| 45 minutes |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000588 |
| Amines |