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NCT Number: NCT02513433

Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia

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

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Key information

Conditions

Pain Insensitivity, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Government Medical College

Haldwani, Uttarakhand, 263139, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

Local anesthetic

Other names: Anawin, Sensorcaine

Levobupivacaine

Drug

Local anesthetic

Other names: Levo-anawin

Ropivacaine

Drug

Local anesthetic

Other names: Ropin

Primary outcomes

  1. Onset of sensory block

    Time frame: 30 minutes

    Time to achieve sensory block up to tenth thoracic dermatome

Secondary outcomes

  1. Time for 2 segment regression of sensory block

    Time frame: 90 minutes

    Time for regression of sensory block 2 segments lower than maximum blocked dermatome

  2. Time to achieve maximum motor block

    Time frame: 45 minutes

    Time to achieve motor block of modified Bromage score

Sponsors and collaborators

Lead sponsor

Government Medical College, Haldwani

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 31, 2015
Registry last updated
Aug 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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