Skip to main content
Clinical Trials/NCT02201784
NCT02201784
Completed
Phase 4

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

Aligarh Muslim University1 site in 1 country60 target enrollmentDecember 2012

Overview

Phase
Phase 4
Intervention
Levobupivacaine
Conditions
Lower Limb Surgery
Sponsor
Aligarh Muslim University
Enrollment
60
Locations
1
Primary Endpoint
Duration of Analgesia
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
January 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

MANAZIR ATHAR

Doctor

Aligarh Muslim University

Eligibility Criteria

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.

Arms & Interventions

Levobupivacaine 0.5%

intrathecal administration of 15 mg of Levobupivacaine 0.5%

Intervention: Levobupivacaine

Ropivacaine 0.75%

intrathecal administration of 22.5 mg of Ropivacaine 0.75%

Intervention: Ropivacaine

Outcomes

Primary Outcomes

Duration of Analgesia

Time Frame: 8 hours

Defined as time for first analgesic request by the patient

Secondary Outcomes

  • Duration of Motor Block(8 hours)
  • Onset of Sensory Block at T10(30 minutes)
  • Median Maximum Level of Sensory Blockade(8 hours)
  • Time to Maximum Cephalic Spread of Sensory Block(8 hours)
  • Onset of Motor Block to Bromage3(8 hours)

Study Sites (1)

Loading locations...

Similar Trials