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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT02201784
Date of registration:	24/07/2014
Prospective Registration:	No
Primary sponsor:	Aligarh Muslim University
Public title:	Spinal Anaesthesia With Levobupivacaine 0.5% and Ropivacaine 0.75% for Lower Limb Orthopaedic Surgery
Scientific title:	A Comparative Study Between Levobupivacaine 0.5% and Ropivacaine 0.75% in Patients Undergoing Spinal Anaesthesia for Lower Limb Orthopaedic Surgery.
Date of first enrolment:	December 2012
Target sample size:	60
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02201784
Study type:	Interventional
Study design:
Phase:	Phase 4

Countries of recruitment
India

Contacts

Name:	Syed Moied Ahmed, PhD, M.D
Address:
Telephone:
Email:
Affiliation:	Jawaharlal Nehru Medical College, AMU, Aligarh, India

Name:	Masood H Siddiqi, M.S
Address:
Telephone:
Email:
Affiliation:	Jawaharlal Nehru Medical College, AMU, Aligarh, India

Name:	Manazir Athar, M.D
Address:
Telephone:
Email:
Affiliation:	Jawaharlal Nehru Medical College, AMU,Aligarh, India

Key inclusion & exclusion criteria

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.

Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Lower Limb Surgery

Intervention(s)

Drug: Levobupivacaine

Drug: Ropivacaine

Primary Outcome(s)

Duration of Analgesia [Time Frame: 8 hours]

Secondary Outcome(s)

Duration of Motor Block [Time Frame: 8 hours]

Time to Maximum Cephalic Spread of Sensory Block [Time Frame: 8 hours]

Median Maximum Level of Sensory Blockade [Time Frame: 8 hours]

Onset of Motor Block to Bromage3 [Time Frame: 8 hours]

Onset of Sensory Block at T10 [Time Frame: 30 minutes]

Secondary ID(s)

jnmch2012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	21/01/2015
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02201784

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