Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia

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

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

Study Overview

• Status: Completed
• Conditions: Pain Insensitivity, Congenital
• Intervention / Treatment: Drug: Ropivacaine; Drug: Bupivacaine; Drug: Levobupivacaine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Uttarakhand
    • Haldwani, Uttarakhand, India, 263139
      • Government Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine & Levobupivacaine; Bupivacaine 15 ml 0.5% and Levobupivacaine 15 ml 0.5% in epidural route before surgery	Drug: Bupivacaine; Local anesthetic; Other Names: Sensorcaine; Anawin; Drug: Levobupivacaine; Local anesthetic; Other Names: Levo-anawin
Active Comparator: Bupivacaine & Ropivacaine; Bupivacaine 15 ml 0.5% and Ropivacaine 15 ml 0.75% in epidural route before surgery	Drug: Ropivacaine; Local anesthetic; Other Names: Ropin; Drug: Bupivacaine; Local anesthetic; Other Names: Sensorcaine; Anawin
Active Comparator: Ropivacaine & Levobupivacaine; Ropivacaine 15 ml 0.75% and Levobupivacaine 15 ml 0.5% in epidural route before surgery	Drug: Ropivacaine; Local anesthetic; Other Names: Ropin; Drug: Levobupivacaine; Local anesthetic; Other Names: Levo-anawin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Government Medical College, Haldwani
• Investigators: Principal Investigator: Geeta Bhandari, M.D., Professor and Head of the department

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: July 30, 2015
• First Submitted That Met QC Criteria: July 30, 2015
• First Posted (Estimate): July 31, 2015

Study Record Updates

• Last Update Posted (Estimate): August 4, 2015
• Last Update Submitted That Met QC Criteria: July 31, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Lumbar epidural anaesthesia
• Additional Relevant MeSH Terms: Nervous System Diseases; Genetic Diseases, Inborn; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pain Insensitivity, Congenital; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Ropivacaine; Levobupivacaine
• Other Study ID Numbers: 65/IEC/01/12-13