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Completed

NCT Number: NCT02201784

Spinal Anaesthesia With Levobupivacaine 0.5% and Ropivacaine 0.75% 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

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Key information

Conditions

Lower Limb Surgery

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Jawaharlal Nehru medical college, AMU

Aligarh, Uttar Pradesh, 202002, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levobupivacaine

Drug

Comparison of Equipotent doses

Other names: Chirocaine

Ropivacaine

Drug

Comparison of equipotent doses

Other names: Naropin

Primary outcomes

  1. Duration of Analgesia

    Time frame: 8 hours

    Defined as time for first analgesic request by the patient

Secondary outcomes

  1. Onset of Sensory Block at T10

    Time frame: 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.

  2. Median Maximum Level of Sensory Blockade

    Time frame: 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.

  3. Time to Maximum Cephalic Spread of Sensory Block

    Time frame: 8 hours

  4. Onset of Motor Block to Bromage3

    Time frame: 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).

  5. Duration of Motor Block

    Time frame: 8 hours

    Time when the Bromage score will be back to zero

Other outcomes

  1. Pulse Rate, Mean Arterial Pressure, SpO2

    Time frame: 8 hours

    Intragroup and intergroup variation compared

Sponsors and collaborators

Lead sponsor

Aligarh Muslim University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 28, 2014
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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