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

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

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

Study Overview

• Status: Completed
• Conditions: Lower Limb Surgery
• Intervention / Treatment: Drug: Levobupivacaine; Drug: Ropivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Uttar Pradesh
    • Aligarh, Uttar Pradesh, India, 202002
      • Jawaharlal Nehru Medical College, AMU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) class I & II patients of either sex
2. Age between 18-60 years

Exclusion Criteria:

1. Patient's refusal.
2. Patients who have contraindications to spinal anaesthesia / Local anaesthetic drugs.
3. Patients having h/o diabetes, neurological and musculoskeletal diseases.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Levobupivacaine 0.5%; intrathecal administration of 15 mg of Levobupivacaine 0.5%	Drug: Levobupivacaine; Comparison of Equipotent doses; Other Names: Chirocaine
Active Comparator: Ropivacaine 0.75%; intrathecal administration of 22.5 mg of Ropivacaine 0.75%	Drug: Ropivacaine; Comparison of equipotent doses; Other Names: Naropin

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulse Rate, Mean Arterial Pressure, SpO2	Intragroup and intergroup variation compared	8 hours

Collaborators and Investigators

• Sponsor: Aligarh Muslim University
• Investigators: Principal Investigator: Manazir Athar, M.D, Jawaharlal Nehru Medical College, AMU,Aligarh, India; Study Director: Syed Moied Ahmed, PhD, M.D, Jawaharlal Nehru Medical College, AMU, Aligarh, India; Study Director: Masood H Siddiqi, M.S, Jawaharlal Nehru Medical College, AMU, Aligarh, India

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: July 24, 2014
• First Submitted That Met QC Criteria: July 24, 2014
• First Posted (Estimate): July 28, 2014

Study Record Updates

• Last Update Posted (Estimate): January 21, 2015
• Last Update Submitted That Met QC Criteria: January 14, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Keywords: spinal anesthesia; ropivacaine; intrathecal; levobupivacaine; Subarachnoid block; isobaric
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine; Levobupivacaine
• Other Study ID Numbers: jnmch2012