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

• Sponsor: Aligarh Muslim University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02201784
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Lower Limb Surgery	Drug: Levobupivacaine; Drug: Ropivacaine	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Comparative Study Between Levobupivacaine 0.5% and Ropivacaine 0.75% in Patients Undergoing Spinal Anaesthesia for Lower Limb Orthopaedic Surgery.
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Levobupivacaine 0.5% intrathecal administration of 15 mg of Levobupivacaine 0.5%	Drug: Levobupivacaine; Comparison of Equipotent doses; Other Names: Chirocaine
Active Comparator: Ropivacaine 0.75% intrathecal administration of 22.5 mg of Ropivacaine 0.75%	Drug: Ropivacaine; Comparison of equipotent doses; Other Names: Naropin

Outcome Measures

Primary Outcome Measures

1. Duration of Analgesia [8 hours]

   Defined as time for first analgesic request by the patient

Secondary Outcome Measures

1. 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.

2. 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.

3. Time to Maximum Cephalic Spread of Sensory Block [8 hours]

4. 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).

5. Duration of Motor Block [8 hours]

   Time when the Bromage score will be back to zero

Other Outcome Measures

1. Pulse Rate, Mean Arterial Pressure, SpO2 [8 hours]

   Intragroup and intergroup variation compared

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jawaharlal Nehru medical college, AMU	Aligarh	Uttar Pradesh	India	202002

Sponsors and Collaborators

• Aligarh Muslim University

Investigators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MANAZIR ATHAR, Doctor, Aligarh Muslim University
• ClinicalTrials.gov Identifier: NCT02201784
• Other Study ID Numbers: jnmch2012
• First Posted: Jul 28, 2014
• Last Update Posted: Jan 21, 2015
• Last Verified: Jan 1, 2015

• Keywords provided by MANAZIR ATHAR, Doctor, Aligarh Muslim University: Subarachnoid block; intrathecal; spinal anesthesia; isobaric; levobupivacaine; ropivacaine
• Additional relevant MeSH terms: Ropivacaine; Levobupivacaine

Study Results

Participant Flow

Recruitment Details	jawaharlal nehru medical college and hospital
Pre-assignment Detail	Patients who met any of the exclusion criteria or those who did not gave consent were excluded.

Arm/Group Title	Levobupivacaine 0.5%	Ropivacaine 0.75%
Arm/Group Description	intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses	intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses
Period Title: Overall Study
STARTED	30	30
COMPLETED	28	30
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Levobupivacaine 0.5%	Ropivacaine 0.75%	Total
Arm/Group Description	intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses	intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses	Total of all reporting groups
Overall Participants	30	30	60
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38 (17)	35 (16)	37 (16)
Sex: Female, Male (Count of Participants)
Female	6 20%	7 23.3%	13 21.7%
Male	24 80%	23 76.7%	47 78.3%
Region of Enrollment (participants) [Number]
India	30 100%	30 100%	60 100%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	53.83 (9.44)	57.17 (6.65)	55.5 (8.27)

Outcome Measures

1. Primary Outcome

Title	Duration of Analgesia
Description	Defined as time for first analgesic request by the patient
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Levobupivacaine 0.5%	Ropivacaine 0.75%
Arm/Group Description	intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses	intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses
Measure Participants	28	30
Mean (Standard Deviation) [minutes]	309.83 (36.45)	249.50 (22.83)

2. Secondary Outcome

Title	Onset of Sensory Block at T10
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Levobupivacaine 0.5%	Ropivacaine 0.75%
Arm/Group Description	intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses	intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses
Measure Participants	28	30
Mean (Standard Deviation) [minutes]	13.50 (4.94)	7.33 (2.54)

3. Secondary Outcome

Title	Median Maximum Level of Sensory Blockade
Description	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	8 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Time to Maximum Cephalic Spread of Sensory Block
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Levobupivacaine 0.5%	Ropivacaine 0.75%
Arm/Group Description	intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses	intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses
Measure Participants	28	30
Mean (Standard Deviation) [minutes]	20.33 (5.31)	13.17 (3.02)

5. Secondary Outcome

Title	Onset of Motor Block to Bromage3
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Levobupivacaine 0.5%	Ropivacaine 0.75%
Arm/Group Description	intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses	intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses
Measure Participants	28	30
Mean (Standard Deviation) [minutes]	12.17 (4.09)	7.83 (2.84)

6. Secondary Outcome

Title	Duration of Motor Block
Description	Time when the Bromage score will be back to zero
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Levobupivacaine 0.5%	Ropivacaine 0.75%
Arm/Group Description	intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses	intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses
Measure Participants	28	30
Mean (Standard Deviation) [minutes]	290.50 (34.67)	222.50 (23.00)

7. Other Pre-specified Outcome

Title	Pulse Rate, Mean Arterial Pressure, SpO2
Description	Intragroup and intergroup variation compared
Time Frame	8 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	Levobupivacaine 0.5%		Ropivacaine 0.75%
Arm/Group Description	intrathecal administration of 15 mg of Levobupivacaine 0.5% Levobupivacaine: Comparison of Equipotent doses		intrathecal administration of 22.5 mg of Ropivacaine 0.75% Ropivacaine: Comparison of equipotent doses
All Cause Mortality
	Levobupivacaine 0.5%		Ropivacaine 0.75%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Levobupivacaine 0.5%		Ropivacaine 0.75%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Levobupivacaine 0.5%		Ropivacaine 0.75%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/30 (36.7%)		13/30 (43.3%)
Cardiac disorders
Bradycardia	2/30 (6.7%)		2/30 (6.7%)
Hypotension	7/30 (23.3%)		10/30 (33.3%)
Gastrointestinal disorders
Nausea	4/30 (13.3%)		2/30 (6.7%)
General disorders
Shivering	3/30 (10%)		5/30 (16.7%)

Limitations/Caveats

Exact baricity was not known as Specific gravity was not measured; Quality of anaesthesia was not assessed

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.