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

Phase 4

Completed

• Conditions: Lower Limb Surgery
• Interventions: Drug: Levobupivacaine; Drug: Ropivacaine

• Registration Number: NCT02201784
• Lead Sponsor: Aligarh Muslim University

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.

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-28
• Status Verified: 2015-01
• Results First Submitted: 2015-01-14
• Results First Submitted QC: 2015-01-14
• Last Update Submitted: 2015-01-14
• Results First Posted: 2015-01-21
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levobupivacaine 0.5%	Levobupivacaine	intrathecal administration of 15 mg of Levobupivacaine 0.5%
Ropivacaine 0.75%	Ropivacaine	intrathecal administration of 22.5 mg of Ropivacaine 0.75%

Primary Outcome Measures

Name	Time	Method
Duration of Analgesia	8 hours	Defined as time for first analgesic request by the patient

Secondary Outcome Measures

Name	Time	Method
Duration of Motor Block	8 hours	Time when the Bromage score will be back to zero
Onset of Sensory Block at T10	30 minutes	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.
Median Maximum Level of Sensory Blockade	8 hours	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.
Time to Maximum Cephalic Spread of Sensory Block	8 hours
Onset of Motor Block to Bromage3	8 hours	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).

Trial Locations

Locations (1)

Jawaharlal Nehru medical college, AMU; 🇮🇳 Aligarh, Uttar Pradesh, India