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

Lower Limb Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201784
• Other study ID #: jnmch2012
• Status: Completed
• Phase: Phase 4
• First received: July 24, 2014
• Last updated: January 14, 2015
• Start date: December 2012
• Est. completion date: January 2014

Study information

• Verified date: January 2015
• Source: Aligarh Muslim University
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lower Limb Surgery

Intervention

Drug:
• Levobupivacaine
Comparison of Equipotent doses
• Ropivacaine
Comparison of equipotent doses

Locations

Country	Name	City	State
India	Jawaharlal Nehru medical college, AMU	Aligarh	Uttar Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Aligarh Muslim University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pulse Rate, Mean Arterial Pressure, SpO2	Intragroup and intergroup variation compared	8 hours	No
Primary	Duration of Analgesia	Defined as time for first analgesic request by the patient	8 hours	No
Secondary	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	No
Secondary	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	No
Secondary	Time to Maximum Cephalic Spread of Sensory Block		8 hours	No
Secondary	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	No
Secondary	Duration of Motor Block	Time when the Bromage score will be back to zero	8 hours	No