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

Phase 4CompletedNCT02201784

Aligarh Muslim University60 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Lower Limb Surgery

Interventions

LevobupivacaineDRUG

Comparison of Equipotent doses

RopivacaineDRUG

Comparison of equipotent doses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (1)

Jawaharlal Nehru medical college, AMU

Aligarh, Uttar Pradesh, India

Outcomes

Primary Outcomes

Duration of Analgesia

Defined as time for first analgesic request by the patient

Time frame: 8 hours

Secondary Outcomes

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.

Time frame: 30 minutes

Median Maximum Level of Sensory Blockade

Time frame: 8 hours

Time to Maximum Cephalic Spread of Sensory Block

Time frame: 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).

Time frame: 8 hours

Duration of Motor Block

Time when the Bromage score will be back to zero

Time frame: 8 hours

Data from ClinicalTrials.gov

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