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CTRI Number  CTRI/2024/12/078433 [Registered on: 23/12/2024] Trial Registered Prospectively
Last Modified On: 20/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparing split doses and single doses of medicine Levobupivacaine for pain relief in legs and abdomen surgeries 
Scientific Title of Study   Comparison of fractionated dose versus bolus dose of injection Levobupivacaine in Spinal Anaesthesia for patients undergoing lower limb and lower abdominal surgery: A Randomized control trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jacinth Hazarika 
Designation  Postgraduate Resident 
Affiliation  Chettinad Hospital and Research Institute, Chennai 
Address  Jacinth Hazarika, Postgraduate Resident, D-Block, 1st Floor, Department Of Anaesthesiology, Chettinad Hospital and Research Institute, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam Chennai

Kancheepuram
TAMIL NADU
603103
India 
Phone  8879302952  
Fax    
Email  jacinthhazarika@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Kulasekar 
Designation  Professor and Head of the Department 
Affiliation  Chettinad Hospital and Research Institute, Chennai 
Address  Professor and Head of the Department, D-Block, 1st Floor, Department Of Anaesthesiology, Chettinad Hospital and Research Institute, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam Chennai

Kancheepuram
TAMIL NADU
603103
India 
Phone  9840498420  
Fax    
Email  ashokk_dr@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Jacinth Hazarika 
Designation  Postgraduate Resident 
Affiliation  Chettinad Hospital and Research Institute, Chennai 
Address  Jacinth Hazarika, Postgraduate Resident, D-Block, 1st Floor, Department Of Anaesthesiology, Chettinad Hospital and Research Institute, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam Chennai

Kancheepuram
TAMIL NADU
603103
India 
Phone  8879302952  
Fax    
Email  jacinthhazarika@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 Jacinth Hazarika  Chettinad Hospital and Research Institute  D-Block, 1st Floor, Department Of Anaesthesiology, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam, Chennai - 603103
Kancheepuram
TAMIL NADU 		 8879302952

jacinthhazarika@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Levobupivacaine Bolus Dose  Intrathecal Levobupivacaine 0.5% heavy 3.5ml (17.5mg) along with an additive drug injection Buprenorphine 0.3ml(90mcg)  
Comparator Agent  Levobupivacaine Fractionated Dose  Fractionated dose of 0.5% Inj Levobupivacaine, two‑third of the total calculated dose given initially followed by one‑third dose after 60 seconds. •After injection of initial two‑third dose, the syringe will be kept attached to the spinal needle for remaining 60 seconds, after which remaining one‑third dose will be administered.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1) ASA GRADE 1, 2 & 3 patients
2) Elective and Emergency Surgeries under Spinal Anaesthesia
 
 
ExclusionCriteria 
Details  1)Patients refusing to participate in the study
2)History of allergy to study drug
3)Patients with infection at the site of injection, coagulopathy, increased Intracranial Pressure
4)Severely altered mental status
5)Spine deformities or history of laminectomy
6)Unknown duration of surgery,
7)Patients converted to general anaesthesia intra-operatively.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare hemodynamic stability and to compare duration of analgesia  First 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1) To assess time of onset, level and regression of motor and sensory block
2) To assess two segment regression time
3) Requirement of vasopressors if any 		 First 24 hours 
 
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)   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="0"
Months="0"
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 Anaesthesia is a commonly used anaesthetic technique in patients undergoing lower-limb, lower abdomen, pelvis and perineum surgeries. It is often preferred over general anaesthesia for its properties of providing a dense block, rapid action, its effect on mental status being minimal, decreased blood loss and its protective effect against thrombo-embolic complications.
•Spinal Anaesthesia causes a sympathetic blockade by way of sympathetic denervation resulting in prolonged and occasionally severe hypotension. This occurs because of the rapid sympathetic block extension, impeding adaptation of cardiovascular system, hence causing significant morbidity and mortality.
•Fractionated dose of a Spinal Anaesthetic can also be administered, in which two thirds of the total calculated dose is initially administered; and one third dose after a time-gap of 60 seconds, which in turn achieves adequate motor and sensory blockade.
•The administration of fractionated dosage of the local anaesthetic agent, provides a dense block with greater hemodynamic stability.
•In recent years levobupivacaine, the pure S (−) enantiomer of bupivacaine, has emerged as a safer alternative for regional anaesthesia than its racemic parent. It demonstrated less affinity and strength of depressant effects onto myocardial and central nervous vital centers in pharmacodynamic studies, and a superior pharmacokinetic profile.
•Clinically, levobupivacaine is well tolerated in a variety of regional anesthesia techniques both after bolus administration and continuous postoperative infusion. Reports of toxicity with levobupivacaine are scarce and occasional toxic symptoms are usually reversible with minimal treatment with no fatal outcome. Levobupivacaine has not entirely replaced bupivacaine in clinical practice.
•In anesthesia and analgesia practice, levobupivacaine and bupivacaine produce comparable surgical sensory block with similar adverse side effects, and equal labor pain control with comparable maternal and fetal outcome. 
AIMS & OBJECTIVES
AIM - The aim of this study is to compare fractionated dose versus bolus dose injection in spinal anaesthesia for patients undergoing lower abdominal surgeries.
OBJECTIVES
Primary objective: To compare hemodynamic stability and duration of analgesia
Secondary objective: To assess time of onset, level and regression of motor and sensory block
To assess two segment regression time
Requirement of vasopressors if any 
STUDY DESIGN - A Randomized Control Trial
SAMPLE SIZE
•Alpha error was taken as 0.03, beta- 0.20,
•k=n2/n1=1
•n1 = (σ12+σ2 2/K) (z1−α/2+z1−β) 2 /Δ2
• Δ = |μ2-μ1| = absolute difference between two means
•σ1, σ2 = variance of mean #1 and #2
•n1 = sample size for group #1
•n2 = sample size for group #2
•α = probability of type I error =2.17 at 97% CI
•β = probability of type II error
•z = critical Z value for a given α or β
•k = ratio of sample size for group #2 to group #1
•n1= 24 subjects in group 1≈ 25 subjects
•n2 = 24 subjects in group 2 ≈ 25 subjects 
•Hence the total sample size will be 50
MATERIALS AND METHODS
Inclusion criteria: ASA GRADE 1, 2 & 3 patients
Age: 18 years to 70 years
Both Gender
Elective and Emergency Surgeries under Spinal Anaesthesia
Exclusion criteria: Patients refusing to participate in the study
History of allergy to study drug
Patients with infection at the site of injection, coagulopathy, increased Intracranial Pressure
Severely altered mental status
Spine deformities or history of laminectomy
Unknown duration of surgery,
Patients converted to general anaesthesia intra-operatively.
METHODOLOGY
Spinal Anaesthesia will be given in sitting position with a 26‑gauge Quincke spinal needle in
L3–L4 or L4–L5 interspace after skin infiltration with 2% Inj Lignocaine. 
On noticing free flow and aspiration of Cerebrospinal Fluid, Inj Levobupivacaine 0.5% 3.5ml(17.5mg) along with Inj Buprenorphine 0.3 ml(90mcg) will be injected according to respective groups, B and F (group B
– bolus dose group F – fractionated dose) 
Group B patients will receive a single bolus dose of 0.5% Inj Levobupivacaine 3.5ml(17.5mg) along with Inj Buprenorphine 0.3ml(90mcg) over 10 seconds
Group F patients will receive fractionated dose of 0.5% Inj Levobupivacaine 3.5ml(17.5mg) along with Inj Buprenorphine 0.3ml(90mcg), two‑third of the total calculated dose given initially followed by one‑third dose after 60 seconds. 
After injection of initial two‑third dose, the syringe will be kept attached to the spinal needle for remaining 60 seconds, after which remaining one‑third dose will be administered. Both the drug will be given at a rate
of 0.2 ml/second. 
Patients will be put in supine position (5-10â—¦ Trendelenburg). 
The time of onset, level and the regression of sensory and motor block will be assessed. 
Assessment of sensory block will be done and confirmed by loss of sensation to pinprick, while modified
Bromage scale will be used to assess motor block. 
Surgeon will be allowed for incision when sensory block at T10 level and Bromage scale of 3 will be achieved.
Patients with inadequate sensory blockade and requiring conversion to general anaesthesia are excluded from the study.
The number of hypotensive episodes and the use Inj. Ephedrine/Inj Phenylephrine will be
recorded. 
The tests will be performed every 5 min till the achievement of maximum sensory and
motor block (Bromage scale 3) and every 30 min post‑operatively until the sensory and motor
variables are back to normal.
REFERENCES
1. Srivastava N, Ahluwalia P, Jheetay GS, Singh G. Bolus dose versus fractionated dose injection
of hyperbaric bupivacaine in spinal anaesthesia among adult patients undergoing lower limb
surgery: A prospective study. Indian J Clin Anaesth 2020;7(2):238-244
2. Bajwa SJ, Kaur J. Clinical profile of levobupivacaine in regional anesthesia: A systematic
review. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):530-9. doi: 10.4103/0970-9185.119172.
PMID: 24249993; PMCID: PMC3819850
3. Goyal A, Singi Y, Mallya P, Bhat G, P S. A Comparison Between Intrathecal Levobupivacaine
and Bupivacaine for Quality and Safety During Infraumbilical Surgeries. Cureus. 2022 Oct
22;14(10):e30590. doi: 10.7759/cureus.30590. PMID: 36426304; PMCID: PMC9681702
4. Derakhshan P, Faiz S H R, Rahimzadeh P, Salehi R, Khaef G. A Comparison of the Effect of
Fractionated and Bolus Dose Injection on Spinal Anesthesia for Lower Limb Surgery: A
Randomized Clinical Trial. Anesth Pain Med. 2020;10(5):e102228.
https://doi.org/10.5812/aapm.102228














 
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