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.
1 other identifier
interventional
60
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2012
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 24, 2014
CompletedFirst Posted
Study publicly available on registry
July 28, 2014
CompletedResults Posted
Study results publicly available
January 21, 2015
CompletedJanuary 21, 2015
January 1, 2015
1.1 years
July 24, 2014
January 14, 2015
January 14, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of Analgesia
Defined as time for first analgesic request by the patient
8 hours
Secondary Outcomes (5)
Onset of Sensory Block at T10
30 minutes
Median Maximum Level of Sensory Blockade
8 hours
Time to Maximum Cephalic Spread of Sensory Block
8 hours
Onset of Motor Block to Bromage3
8 hours
Duration of Motor Block
8 hours
Other Outcomes (1)
Pulse Rate, Mean Arterial Pressure, SpO2
8 hours
Study Arms (2)
Levobupivacaine 0.5%
ACTIVE COMPARATORintrathecal administration of 15 mg of Levobupivacaine 0.5%
Ropivacaine 0.75%
ACTIVE COMPARATORintrathecal administration of 22.5 mg of Ropivacaine 0.75%
Interventions
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiologists (ASA) class I \& II patients of either sex
- Age between 18-60 years
You may not qualify if:
- Patient's refusal.
- Patients who have contraindications to spinal anaesthesia / Local anaesthetic drugs.
- Patients having h/o diabetes, neurological and musculoskeletal diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jawaharlal Nehru medical college, AMU
Aligarh, Uttar Pradesh, 202002, India
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Exact baricity was not known as Specific gravity was not measured; Quality of anaesthesia was not assessed
Results Point of Contact
- Title
- Dr. Manazir Athar
- Organization
- Jawaharlal Nehru Medical College, AMU, Aligarh, India
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
July 24, 2014
First Posted
July 28, 2014
Study Start
December 1, 2012
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
January 21, 2015
Results First Posted
January 21, 2015
Record last verified: 2015-01