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CTRI Number  CTRI/2022/11/047010 [Registered on: 03/11/2022] Trial Registered Prospectively
Last Modified On: 02/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparison of hyperbaric levobupivacaine and hyperbaric ropivacaine in spinal anaesthesia for lower limb surgery 
Scientific Title of Study   Hyperbaric levobupivacaine versus hyperbaric ropivacaine in spinal anaesthesia for lower limb surgeries-a randomized control trial 
Trial Acronym  levo-ropi 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR NEEHARIKA ARORA 
Designation  PROFESSOR 
Affiliation  ROHILKHAND MEDICALCOLLEGE AND HOSPITAL 
Address  ROOM NO. 2062-D, AANAESTHEISA DEPARTMENT, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, PILIBHIT BYPASS ROAD, BAREILLY - 243006,

Bareilly
UTTAR PRADESH
243006
India 
Phone  8077104070  
Fax    
Email  docneehars@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR NEEHARIKA ARORA 
Designation  PROFESSOR 
Affiliation  ROHILKHAND MEDICALCOLLEGE AND HOSPITAL 
Address  ROOM NO. 2062-D, AANAESTHEISA DEPARTMENT, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, PILIBHIT BYPASS ROAD, BAREILLY - 243006,

Bareilly
UTTAR PRADESH
243006
India 
Phone  8077104070  
Fax    
Email  docneehars@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DRKAREENA POPAT 
Designation  JUNIOR RESIDENT 
Affiliation  ROHILKHAND MEDICALCOLLEGE AND HOSPITAL 
Address  ROOM NUMBER 23, PG AC GIRLS HOSTEL, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, PILIBHIT BYPASS ROAD, BAREILLY- 243006
ROOM NO. 2062-D, ANAESTHEISA DEPARTMENT, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, PILIBHIT BYPASS ROAD, BAREILLY - 243006
Bareilly
UTTAR PRADESH
243006
India 
Phone  7060899224  
Fax    
Email  kareenapopat@gmail.com  
 
Source of Monetary or Material Support  
ROHILKHAND MEDICAL COOLEGE AND HOSPITAL 
 
Primary Sponsor  
Name  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL 
Address  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL, PILIBHIT BYPASS ROAD, BAREILLY - 243006 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR NEEHARIKA ARORA  OPERATION THEATRE, ROHILKHAND MEDICAL COLLEGE AND HOSPITAL   DEPARTMENT OF ANAESTHESIOLOGY
Bareilly
UTTAR PRADESH 
8077104070

docneehars@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  spinal anaesthesia with hyperbaric levobupivacaine  3 ml hyperbaric levobupivacaine 0.5% given intrathecal 
Comparator Agent  spinal anaethesia with hyperbaric ropivacaine  3ml hyperbaric ropivacaine 0.75% given intrathecal  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.American society of Anaesthesiologist (ASA) grade I or II

2.BMI< 30
3.Lower limb surgeries
 
 
ExclusionCriteria 
Details  1.Patients with contra-indication to Spinal anaesthesia
2.Obesity (BMI>30kg/m2)
3.Any neuropathies
4.Allergy or intolerance to Local Anaesthetics
5.Patient refusal for procedure
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Onset and duration of sensory block.
2.Onset and duration of motor block.
3.Peak height for sensory block.
4.2-segment regression time
 
The patient will be evaluated for sensory and motor block, for every 2 minutes for first 20 minutes, every 3 minutes for next 30 minutes, every 10 minutes for 60 minutes, and finally every 15 minutes until the sensory block has regressed to S1 dermatome.
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Hemodynamic changes.
2.Any Side effects / Complication.
 
patient’s pulse, Systolic Blood pressure, Diastolic Blood pressure, Mean Arterial Pressure, heart rate will be recorded every 3 minutes for 30 minutes and then every 5 mins for next 30mins and then 15mins until completion of the surgery. 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/11/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 Spinal anaesthesia has several benefits as it provides prolonged post-operative analgesic effect, has rapid onset and offset, easy administration, is pocket friendly, reliable, safe, patient is awake unlike in general anaesthesia and there is decreased risk of aspiration.

Earlier hyperbaric solutions of Levobupivacaine and Ropivacaine were prepared in operating room but now hyperbaric solutions of these drugs are available in the market in concentration of 0.5% and 0.75% respectively each combined with 80 mg of dextrose. The disadvantage of preparing these hyperbaric solutions in operating room was that density of each newly prepared solution was different, so the results could not be reproduced reliably.

Previous studies by Casati used Levobupivacaine and Ropivacaine by adding dextrose (30mg) in operating room and the specific gravities of the Hyperbaric Bupivacaine was 1.00874g/ml, Hyperbaric Levobupivacaine was 1.00945g/ml and Hyperbaric Ropivacaine was 1.00876g/ml.6

This can be compared with the newer preparations available of Hyperbaric Levobupivacaine which has specific gravity of 1.025-1.035 and Hyperbaric Ropivacaine which has specific gravity of 1.025-1.035. The newer preparations of both Hyperbaric Levobupivacaine and Hyperbaric Ropivacaine contains 80mg dextrose in each ml and have similar specific gravity.

As earlier studies on hyperbaric ropivacaine and levobupivacaine, solutions used were prepared by addition of dextrose prior to administration, so baricity was unreliable with specific gravity unknown. Hence, in this study, we aim to compare the efficacy of two newly available hyperbaric preparations of hyperbaric Levobupivacaine and hyperbaric Ropivacaine in lower limb surgeries.

 Spinal Anaesthesia will be administered to the patient in L2-L3 interspace with patient sitting using a midline approach using 25G spinal needle. According to randomization, patient will receive either preservative free formulation of hyperbaric ropivacaine 0.75% (3ml) or hyperbaric levobupivacaine 0.5% (3ml). No adjuvant medication will be added to either local anaesthetic.

After completion of the spinal injection, patient will be immediately made to lie supine with operating table horizontal. The patient will be evaluated for sensory and motor block, for every 2 minutes for first 20 minutes, every 3 minutes for next 30 minutes, every 10 minutes for 60 minutes, and finally every 15 minutes until the sensory block has regressed to S1 dermatome.

The patient will be administered Inj. Midazolam 1mg iv after spinal Anaesthesia has been given. During the surgery the patient’s pulse, Systolic Blood pressure, Diastolic Blood pressure, Mean Arterial Pressure, heart rate will be recorded every 3 minutes for 30 minutes and then every 5 mins for next 30mins and then 15mins until completion of the surgery.

The sensory level of the block will be assessed in a caudal to cephalad direction, using loss to pin prick sensation, and the C5-C6 dermatome is used as an unblocked reference point.

 The motor Block will be assessed using the Modified Bromage Scale.Readiness for surgery is defined as loss of pin prick sensation ≥ T10 with modified Bromage≥2. During surgery, evaluation of the motor block will be suspended until the end of the procedure. If the patient complains of pain, Inj Butorphanol 1 mg I.V. will be administered.
If additional sedation is needed, midazolam 1 mg I.V. will be administered. The total dose of any given medication will be recorded. If the patient still feels pain, general anaesthesia will be provided and the case will be excluded from the study. Any complications, side effects and adverse effects up to 24 hours postoperatively will be noted.  
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