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CTRI Number  CTRI/2024/12/078362 [Registered on: 20/12/2024] Trial Registered Prospectively
Last Modified On: 18/12/2024
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   A comparison of two spinal anaesthesia drugs Levobupivacaine 0.5 percent and Ropivacaine 0.75 percent combined with Buprenorphine in patients undergoing surgeries on the lower abdomen and legs 
Scientific Title of Study   Comparative study of Intrathecal Hyperbaric Levobupivacaine 0.5 percent and Hyperbaric Ropivacaine 0.75 percent with Buprenorphine in patients undergoing lower abdominal and lower limb procedures under subarachnoid block. A prospective randomised double blind 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  S VAISHNAVI 
Designation  POSTGRADUATE RESIDENT  
Affiliation  CHETTINAD HOSPITAL AND RESEARCH INSTITUTE 
Address  D-BLOCK, 1ST FLOOR, DEPARTMENT OF ANAESTHESIOLOGY, CHETTINAD HOSPITAL AND RESEARCH INSTITUTE, CHETTINAD HEALTH CITY, RAJIV GANDHI SALAI, KELAMBAKKAM

Chennai
TAMIL NADU
603103
India 
Phone  9600444116  
Fax    
Email  vaishu.arsha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR ASHOK KULASEKHAR 
Designation  PROFESSOR HEAD OF THE DEPARTMENT 
Affiliation  CHETTINAD HOSPITAL AND RESEARCH INSTITUTE 
Address  PROFESSOR HEAD OF THE DEPARTMENT, D-BLOCK, 1ST FLOOR, DEPARTMENT OF ANAESTHESIOLOGY, CHETTINAD HOSPITAL AND RESEARCH INSTITUTE, CHETTINAD HEALTH CITY, RAJIV GANDHI SALAI, KELAMBAKKAM

Chennai
TAMIL NADU
603103
India 
Phone  9840498420  
Fax    
Email  ashokk_dr@yahoo.com  
 
Details of Contact Person
Public Query  
Name  S VAISHNAVI 
Designation  POSTGRADUATE RESIDENT 
Affiliation  CHETTINAD HOSPITAL AND RESEARCH INSTITUTE 
Address  D-BLOCK, 1ST FLOOR, DEPARTMENT OF ANAESTHESIOLOGY, CHETTINAD HOSPITAL AND RESEARCH INSTITUTE, CHETTINAD HEALTH CITY, RAJIV GANDHI SALAI, KELAMBAKKAM

Chennai
TAMIL NADU
603103
India 
Phone  9600444116  
Fax    
Email  vaishu.arsha@gmail.com  
 
Source of Monetary or Material Support  
Chettinad Hospital And Research Institute, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam, Chennai, Tamil Nadu, India-603103 
 
Primary Sponsor  
Name  Chettinad Hospital And Research Institute  
Address  Chettinad Hospital And Research Institute, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam, Chennai, Tamil Nadu, India-603103  
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 S VAISHNAVI  CHETTINAD HOSPITAL AND RESEARCH INSTITUTE  D-BLOCK, 1ST FLOOR, DEPARTMENT OF ANAESTHESIOLOGY, CHETTINAD HOSPITAL AND RESEARCH INSTITUTE, CHETTINAD HEALTH CITY, RAJIV GANDHI SALAI, KELAMBAKKAM INDIA-603103
Chennai
TAMIL NADU 		 9600444116

vaishu.arsha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Chettinad Academy of Research and Education Institutional Human Ethics Committee for Student Research (CARE IHEC-I)  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  Levobupivacaine with Buprenorphine   Intrathecal Levobupivacaine 0.5% heavy with Buprenorphine 60mcg to assess onset and duration of sensory and motor blockade in patients undergoing lower abdominal and lower limb procedures under subarachnoid block and will be assessed up to 5 hours postoperatively 
Comparator Agent  Ropivacaine with Buprenorphine   Intrathecal Ropivacaine 0.75% heavy with Buprenorphine 60mcg to assess onset and duration of sensory and motor blockade in patients undergoing lower abdominal and lower limb procedures under subarachnoid block and will be assessed up to 5 hours postoperatively 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.American Society of Anesthesiologists (ASA) grade I-III.
2. Age group between 18-60 years of both sexes.
3. Scheduled for Elective and emergency lower abdominal and lower limb surgeries under subarachnoid block
 
 
ExclusionCriteria 
Details  1. Patient refusal
2. History of allergy to study drugs
3. Post spinal surgeries, Spinal Deformities, skin sepsis in lumbar region, patients with pre-existing neurological disorders.
4. Coagulopathy, Dysrhythmia
5. Major Hepatic, Renal and Cardiovascular Dysfunction
6. BMI more than 35, Height less than 140cms
7. Surgeries involving major blood loss
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To compare onset and duration of sensory and motor blockade.
2.To assess and compare the haemodynamic parameters between both groups.
 		 First 5 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess two segment sensory regression time
2.Side effect if any
 		 First 5 hours 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   31/12/2024 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   INTRODUCTION 
  • Spinal anesthesia is a common safe, economical, easy to perform and effective technique which provides rapid and reliable anesthesia with muscle relaxation for patients undergoing lower abdominal surgery[2]. 
  • The recognition of acute life threatening cardio toxicity of Bupivacaine led to the search for a local anaesthetic agent comparable with Bupivacaine but with lower cardio toxicity and neurotoxicity resulting in development  of a relatively newer amide, Levobupivacaine and Ropivacaine[1].
  • Ropivacaine is the pure S(-) enantiomer, new long-acting amino amide with lower lipid solubility[2]. Levobupivacaine has a lower affinity for cardiac sodium channels and greater plasma protein binding affinity compared with the dextro isomer; thus, reducing the risk of cardio-toxicity[3]
  • Buprenorphine is a semi synthetic derivative of opium alkaloid thebaine, a potent and safe analgesic (75 to 100 times greater than that of morphine) at 5-10% receptor occupancy causing less respiratory depression.It is a partial mu agonist and has k receptor antagonist property[4]
AIMS & OBJECTIVES
    AIM:  
    To compare the efficacy of Intrathecal Hyperbaric Levobupivacaine (0.5%) and Hyperbaric Ropivacaine (0.75%) with            Buprenorphine in patients undergoing lower abdominal and lower limb procedures under subarachnoid block.


    PRIMARY OBJECTIVE:

    1.To compare onset and duration of sensory and motor blockade.

    2.To assess and compare the haemodynamic parameters between both groups.

    SECONDARY OBJECTIVE:

    1.To assess two segment sensory regression time 

    2.Side effect if any


    STUDY DESIGN
    A prospective randomised double-blind study.

    Sample size: 70. Group A =35; Group B=35. 

    The sample size was calculated using the formula for an RCT with two independent means and standard deviations. The formula is as follows:


    n= 2(Z Î±/2 + Zβ)2. Ïƒ2   /  (μ1- Î¼2)2 

     

    n= Required sample size per group.

    μ 1= Mean of the first group.

    μ  2= Mean of the second group.

    σ = Pooled standard deviation of the two groups.

    Based on a similar study conducted by Oraon et al., which reported a total duration of analgesia of 137.67±16.95 minutes in the Levobupivacaine group and 126.67±15.55 minutes in the Ropivacaine group, the required sample size for a power of 0.80 and a significance level of 0.05 was calculated to be 70, with 35 participants in each group.


    STUDY TYPE : Interventional


    STUDY POPULATION After Ethical Committee approval and CTRI registration, 70 patients who will undergo elective or emergency lower abdominal and lower limb surgeries at Chettinad Hospital and Research Institute, Kelambakkam, Chennai, will be taken up for study.

    SAMPLE SIZE : The sample size was calculated using the formula for an RCT with two independent means and standard deviations. 

    Sample size: 70 Group A = 35; Group B = 35 . Patients in each group will receive anaesthesia as follows: 

    Group A (n=35) :Patients will receive 3.5 ml of Hyperbaric LEVOBUPIVACAINE (0.5%) + 0.2 ml Buprenorphine (60mcg) 

    Group B (n=35) :Patients will receive 3.5 ml of Hyperbaric ROPIVACAINE (0.75%) + 0.2 ml Buprenorphine (60mcg)


     

    MATERIAL AND METHODS


    INCLUSION CRITERIA

    1. American Society of Anesthesiologists (ASA) grade I-III.

     2. Age group between 18-60 years of both sexes.

     3. Scheduled for Elective and emergency lower abdominal and lower limb surgeries under Spinal Anaesthesia

    EXCLUSION CRITERIA

    1. Patient refusal

     2. History of allergy to study drugs

     3. Post spinal surgeries, Spinal Deformities, skin sepsis in lumbar region, patients with pre-existing neurological disorders. 

    4. Coagulopathy, Dysrhythmia 

    5. Major Hepatic, Renal and Cardiovascular Dysfunction 

    6. BMI >35, Height <140cm

     7. Surgeries involving major blood loss

    METHODOLOGY
    • The enrolled subjects will be randomised into the 2 study groups using computer  generated randomisation code.
    •  All the patients will receive Tab Alprazolam 0.5mg HS and Tab Ranitidine 150mg HS and 6am in the morning of surgery. 
    • On arrival in Pre-op area an IV access with 18G IV cannula will be secured and RL will be started 
    • Establishment of proper standard monitoring systems (pulse oximetry, continuous electrocardiography and non-invasive blood pressure monitoring and SpO2)
    • Sitting position is recommended for all patients included in this study.
    • Under all aseptic precautions L3-L4 inter-space will be infiltrated with 2ml of 2% Inj. Lignocaine. 
    • Study drug will be prepared by the person not involved in the study. 
    • The subarachnoid space will be entered at L3-L4 intervertebral-space via the midline approach using 26-Gauge Quincke spinal needle. 
    • The correct needle placement will be identified by free flow of cerebrospinal fluid and 3.7 ml of study drug will be injected by the anaesthesiologist
    • The patient will be placed in supine position to carry over the initial assessment
    • The onset of sensory and motor blockade will be assessed at baseline and 3 minutes interval up to 15 minutes 
    • The onset of sensory blockade will be considered as loss of cold sensations at T10 level and the highest level of sensory blockade will also be noted.
    • The onset of motor blockade will be evaluated using Modified Bromage score of 2.
    • Two segment sensory blockade and the regression of Motor Blockade to score of 0 will be noted at the end of the procedure. The duration of sensory blockade is taken as the two segment regression and the duration of motor block is taken Modified Bromage score of 0
    • The duration of analgesia is taken as the time taken for the first analgesic need for the patient. 
    • Continuous Vital monitoring includes patient’s Heart rate, Non invasive Blood Pressure, Respiratory Rate and SpO2 will be monitored at 3 minutes interval up to 15 minutes then every 5 minutes up to 30 minutes. 
    • The Modified Bromage score and level of sensory blockade will be noted for every 30 minutes up to 5 hours
    POST-OPERATIVE PAIN AND SIDE EFFECTS
    • Post-surgery, the time for request of first rescue analgesia will be noted from the time of administration of spinal anaesthesia to complain of pain VAS score of >/=3 (i.e. 0=No Pain, 10=worst imaginable pain). 
    •  In case of Pain Inj. Tramadol 50 mg will be given intravenously. 
    • Side effects such as nausea and vomiting will be treated using Inj. Ondensetron 4mg IV, Bradycardia by Inj. Atropine 0.6mg and Hypotension by adequate fluids or if required Inj. Ephedrine 6mg


    REFERENCE 

     1. Dr Alpa M Patel, Dr Astha P Naik, Dr Nirali N Panchal. Effectiveness of Ropivacaine versus Levobupivacaine for Spinal Anaesthesia and Analgesia in Lower Limb Surgery. JMSCR Vol||06||Issue||02||Page 930-937||February

    2. Gupta R, Bogra J, Singh PK, Saxena S, Chandra G, Kushwaha JK. Comparative study of intrathecal hyperbaric versus isobaric ropivacaine: A randomized control trial. Saudi J Anaesth 2013;7:249-53.

    3. Singh A, Gupta A, Datta PK, Pandey M. Intrathecal levobupivacaine versus bupivacaine for inguinal hernia surgery: a randomized controlled trial. Korean J Anesthesiol. 2018 Jun;71(3):220-225. doi: 10.4097/kja.d.18.27191. Epub 2018 Apr 24. 

    4. Arghya Maity, Rajasree Biswas, Suchismita Mallick. Comparison between transdermal buprenorphine and intravenous paracetamol for post-operative analgesia after major plastic reconstructive surgery under general anesthesia-A randomized double-blind controlled trial.DOI: 10.3126/ajms.v14i3.50054

    5. Oraon P, Hembrom B, Kumar M, Ram B, Lakra L. Comparative study between intrathecal 0.5% isobaric levobupivacaine, 0.5% isobaric ropivacaine, and 0.5% hyperbaric bupivacaine in elective lower segment cesarean section: A randomized clinical study. Anesth Essays Res 2022;16:238-43.

     
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