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CTRI Number  CTRI/2023/09/057689 [Registered on: 15/09/2023] Trial Registered Prospectively
Last Modified On: 14/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Spinal Anaesthesia comparison with hyperbaric drug in lower limb surgeries 
Scientific Title of Study   Comparison between hyperbaric levobupivacaine with buprenorphine and hyperbaric ropivacaine with buprenorphine for spinal anesthesia in patients undergoing lower limb surgery: A prospective randomised study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr NAVANEETHAN N K 
Designation  Postgraduate in Department of Anaesthesiology 
Affiliation  Rajarajeswari medical college and hospital 
Address  Department of Anesthesiology,Rajarajeswari medical college and hospital,Kambipura,Mysore road, Bangalore

Bangalore
KARNATAKA
560074
India 
Phone  9444960258  
Fax    
Email  navaneethan.karthikeyan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr NADIA ROSE 
Designation  Associate Professor 
Affiliation  Rajarajeswari medical college and hospital 
Address  Department of Anesthesiology,Rajarajeswari medical college and hospital,Mysore road,Kambipura,Bangalore

Bangalore
KARNATAKA
560074
India 
Phone  9513454567  
Fax    
Email  dr.nadia.rose@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr NADIA ROSE 
Designation  Associate Professor 
Affiliation  Rajarajeswari medical college and hospital 
Address  Department of Anesthesiology,Rajarajeswari medical college and hospital,Mysore road,Kambipura,Bangalore

Bangalore
KARNATAKA
560074
India 
Phone  9513454567  
Fax    
Email  dr.nadia.rose@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology,2nd floor,Rajarajeswari medical college and hospital,Bangalore-560074 
 
Primary Sponsor  
Name  Rajarajeswari medical college and hospital 
Address  Department of Anesthesiology,Rajarajeswari medical college and hospital,Kambipura,Mysore road,Bangalore,Karnataka-560074 
Type of Sponsor  Research institution and hospital 
 
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 NAVANEETHAN N K  Rajarajeswari medical college and hospital  Department of Anesthesiology,Rajarajeswari medical college and hospital,Kambipura,Mysore road,Bangalore
Bangalore
KARNATAKA 
9444960258

navaneethan.karthikeyan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee,Rajarajeswari medical college and hospital  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 
Comparator Agent  Spinal anesthesia with hyperbaric 0.5 % levobupivacaine with buprenorphine 60mcg  Intrathecal administration of hyperbaric 0.5 % levobupivacaine 3ml with 60mcg buprinorphine 
Intervention  Spinal anesthesia with hyperbaric 0.75% ropivacaine with buprenorphine 60mcg  Intrathecal administration of hyperbaric 0.75% ropivacaine with 60 mcg buprenorphine  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. ASA I and II patients of either sex undergoing elective lower limb surgeries.2.Patients aged between 20 to 60 years 
 
ExclusionCriteria 
Details  1. Patients with bradycardia.(HR less than 50)
2. Patients with known hypersensitivity to local anaesthetic drugs.
3. Pregnant and lactating women
4.Contraindication to spinal anesthesia (Patient refusal, Coagulopathy, Local infection)
5. Patients diagnosed to have neurological diseases and Musculoskeletal diseases
6. Patients with previous spine surgeries and spine abnormalities.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare onset of sensory blockade between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine and 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeries  After giving spinal anesthesia  
 
Secondary Outcome  
Outcome  TimePoints 
To compare onset of motor blockade between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine & 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeries  After giving spinal anaesthesia 
To compare duration of sensory blockade between intrathecal 0.5% (H) Levobupivacaine with buprenorphine & 0.75% (H) Ropivacaine with buprenorphine in lower limb surgeries  During surgery 
To compare duration of analgesia between intrathecal 0.5% (H) levobupivacaine with buprenorphine & 0.75% (H) ropivacaine with buprenorphine in lower limb surgeries  During & after surgery 
To compare hemodynamic changes between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine & 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeries  During & after surgery 
To compare side effects between intrathecal 0.5%(H) Levobupivacaine with Buprenorphine & 0.75%(H) Ropivacaine with Buprenorphine in Lower limb surgeries  After giving spinal anesthesia 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   Phase 4 
Date of First Enrollment (India)   25/09/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Spinal Anaesthesia  is a safe and effective form of anaesthesia widely used in anaesthetic practise as an alternative to general anaesthesia in surgeries that involve lower extremities and infraumbilical region. It provides good anaesthesia,analgesia,motor,sensory blockade but bradycardia and hypotension are its most common side effects. Local anaesthetic bupivacaine is the most commonly used agent at present but it has high cardiac and central nervous system toxicity compared to other agents.1

 

            Levobupivacaine which is an S (-)- enantiomer of  bupivacaine is long acting local anesthetic which has with high potency.1 It has less cardiotoxic and central nervous system effects in comparison with both R(+) bupivacaine and bupivacaine. Several studies have been conducted to compare Bupivacaine and Levobupivacaine in various forms and it has been shown that Levobupivacaine has efficacy similar to Bupivacaine  with higher safety profile.2,3

 

Ropivacaine an amino amide local anaesthetic , is the S-Enantiomer of a bupivacaine, which has low  cardiac toxicity as well as CNS toxicity.It has been found to be less potent than Bupivacaine and Levobupivacaine.1

 

 

Buprenorphine is an agonist-antagonist opioid which acts as an antagonist at kappa receptor and partial agonist at µ receptor. It has been studied as adjuvant in spinal anesthesia.Opioid adjuvants in spinal anesthesia has been shown to enhance to quality of anesthesia and analgesia.4

 

Need for study-After extensive search of literature we found that not many studies has been done in comparing in equipotent doses of levobupivacaine and ropivacaine in spinal anesthesia,hence we are doing this study to compare the same, more over due to better safety profile levobupivacaine has good prospects in replacing in bupivacaine as a drug of choice for spinal anesthesia.1

 
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