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

• ClinicalTrials.gov Identifier: NCT02201784
• Recruitment Status: Completed
• First Posted: July 28, 2014
• Results First Posted: January 21, 2015
• Last Update Posted: January 21, 2015
• Sponsor: Aligarh Muslim University
• Information provided by (Responsible Party): MANAZIR ATHAR, Aligarh Muslim University

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 (Clinical Trial)
• 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: December 2012
• Actual Primary Completion Date: January 2014
• Actual Study Completion Date: January 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 Name: Chirocaine
Active Comparator: Ropivacaine 0.75%; intrathecal administration of 22.5 mg of Ropivacaine 0.75%	Drug: Ropivacaine; Comparison of equipotent doses; Other Name: Naropin

Outcome Measures

Primary Outcome Measures :

1. Duration of Analgesia [ Time Frame: 8 hours ]
   Defined as time for first analgesic request by the patient

Secondary Outcome Measures :

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 Outcome Measures:

1. Pulse Rate, Mean Arterial Pressure, SpO2 [ Time Frame: 8 hours ]
   Intragroup and intergroup variation compared

Eligibility Criteria

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

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.

Contacts and Locations

Locations

India

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

More Information

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

Keywords provided by MANAZIR ATHAR, Aligarh Muslim University:

Subarachnoid block; intrathecal; spinal anesthesia; isobaric; levobupivacaine; ropivacaine

Additional relevant MeSH terms:

Ropivacaine; Levobupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents