| CTRI Number |
CTRI/2025/02/080326 [Registered on: 11/02/2025] Trial Registered Prospectively |
| Last Modified On: |
07/02/2025 |
| 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
|
To compare divided dose vs one single dose of drug injected into the spinal area to evaluate haemodynamic stability of patients undergoing lower abdominal surgeries and lower limb surgeries |
|
Scientific Title of Study
|
Comparison of fractionated dose versus bolus dose injection in spinal anaesthesia for patients undergoing lower abdominal and lower limb surgery A prospective randomise single-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 |
Akalya Jayapal |
| Designation |
Postgraduate Resident |
| Affiliation |
Chettinad Hospital And Research Institute |
| Address |
Akalya Jayapal, postgraduate Resident, D- block, 1st floor, Department of Anaesthesiology, Chettinad Hospital And Research Institute, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam
Kancheepuram TAMIL NADU 603103 India |
| Phone |
8056894214 |
| Fax |
|
| Email |
akalyajs@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ashok Kulasekhar |
| Designation |
Professor Head Of Department |
| Affiliation |
Chettinad Hospital And Research Institute |
| Address |
Professor , Head of Department,D- block, 1st floor, Department of Anaesthesiology, Chettinad Hospital And Research Institute, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam
Kancheepuram TAMIL NADU 603103 India |
| Phone |
9840498420 |
| Fax |
|
| Email |
ashokk_dr@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Akalya Jayapal |
| Designation |
Postgraduate Resident |
| Affiliation |
Chettinad Hospital And Research Institute |
| Address |
Akalya Jayapal , Postgraduate Resident, D- block, 1st floor, Department of Anaesthesiology, Chettinad Hospital And Research Institute, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam
Kancheepuram TAMIL NADU 603103 India |
| Phone |
8056894214 |
| Fax |
|
| Email |
akalyajs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad hospital and research institute Chettinad health city SH 49 A, Kelambakkam,Tamilnadu ,India -603103 |
|
|
Primary Sponsor
|
| Name |
Chettinad Hospital and Research Institute |
| Address |
Chettinad Hospital and Research Institute,Chettinad Health City,Rajiv Gandhi Salai,Kelambaakam ,Tamilnadu ,India-603013 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akalya Jayapal |
Chettinad Hospital and Research Institute |
D-Block, 1st Floor, Department Of Anaesthesiology, Chettinad Health City, Rajiv Gandhi Salai, Kelambakkam Kancheepuram TAMIL NADU |
8056894214
akalyajs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL HUMAN ETHICS COMMITTEE(CARE IHEC -1) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bolus dose injection of bupivacaine and buprenorphine. |
Bolus dose injection in spinal anaesthesia for patients undergoing lower abdominal surgeries and lower limb surgeries and compare haemodynamic stability and to assess time of onset and highest level of motor and sensory block. |
| Intervention |
Fractionate dose injection of bupivacaine and buprenorphine. |
Fractionated dose injection in spinal anaesthesia for patients undergoing lower abdominal surgeries and lower limb surgeries and compare haemodynamic stability and to assess time of onset and highest level of motor and sensory block. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.American society of anaesthesiologist (ASA) grade I - III 2.Age 18 - 40yrs 3.Scheduled for lower abdominal surgeries under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Patient Refusal 2.History of allergy to study drug 3. Post spinal surgeries 4.spinal deformities 5.skin sepsis in lumbar region. 6.Patients with pre-existing neurological disorders 7.Coagulopathy
8.Major hepatic,renal and cardiovascular malformation 9.Weight less than 60kg and more than 110kgs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare haemodynamic stability of both groups. |
6 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing the time of onset and highest level of motor and sensory block. |
6hours |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
18/02/2025 |
| 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
|
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 and an effective technique which provides rapid and reliable anaesthesia with muscle relaxation for patients undergoing lower abdominal surgery and lower limb surgery Spinal anaesthesia is routinely used to provide anaesthesia for elective and emergency surgeries Intensity and duration of spinal block is influenced by numerous factors like height, weight,dose of local anaesthetics drug and anatomy of spine. There are no studies done comparing the effect of fractionated dose versus bolus dose injection in spinal anaesthesia using 0.5% bupivacaine plus buprenorphine in patients undergoing lower abdominal surgeries.
OBJECTIVES Primary Objective : To compare haemodynamic stability between two groups.
Secondary Objective : To assess time of onset and highest level of motor and sensory block.
STUDY DESIGN A prospective randomized controlled single blind study.
SAMPLE SIZE Sample size is calculated for the two independent study group for continuous variables for randomised control trial. 20 samples in each group was taken and total sample size will be 40.
MATERIALS AND METHODS
Inclusion criteria:
American society of anesthesiologist (ASA) I -III Age 18 - 40yrs Scheduled for lower abdominal surgeries under spinal anaesthesia
Exclusion criteria :
Patient refusal History of allergy to study drug Post spinal surgeries, Spinal deformities Skin sepsis in lumbar region Patients with pre-existing neurological disorders Coagulopathy Major hepatic, renal and cardiovascular dysfunction Weight <60kgs and >110kg .
METHODOLOGY
In the preoperative assessment detailed history and physical examination, baseline data like pulse rate, blood pressure, SpO2 and basic investigations will be collected. Informed and written consent will be obtained. The enrolled subjects will be randomized into the 2 study groups using computer generated randomisation code. Patients will not be informed which group will be receiving the fractionated dose and bolus dose.Single blinding is done to avoid patient bias in assessing the objectives.All the patients will receive Tab Alprazolam 0.5mg HS and Tab Ranitidine 150mg HS at 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. SA was given in sitting position with the 26 guage Quincke spinal needle in L3 - L4 or L4- L5 interspace after skin infiltration with lignocaine. After aspiration of cerebrospinal fluid, injection bupivacaine 0.5% heavy plus buprenorphine was 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 bupivacaine + buprenorphine over 10 s.Group F patients will recieve fractionated dose of bupivacaine + buprenorphine with two-third of the total calculated dose goven initially followed by one-third dose after 60 sec.Both will be given at the rate of 0 2ml/s.After injection of initial two-third dose , the syringe was kept attached to the spinal needle for remaining 60s , after which remaining one-third dose was administered. The number of hypotensive episodes and the use of Inj.Ephedrine will be recorded and time of onser of motor and sensory block will be recorded. The tests will be performed every 5 minutes till the achievement of maximum sensory and motor block (Bromage scale 3) and every 30 min post-operatively until the sensory and motor variables were back to normal. The onset of sensory blockade will be considered as loss of cold sensation at T10 level and highest level of sensory blockade will be noted. The onset of motor blockade will be evaluated using modified bromage score of 2.
REFERENCES
1. Jigisha prahaladray Bandheka, Vrinda pravinbhai oza, Ashutosh Vyas, Deepika baria, Poonam Nehra, Thomas babu.comparsio fractionated dose versus bolus dose injection in spinal anaesthesia for patients undergoing elective caesarean section: A randomised double blinded study.
2. Vanagondi Siva Kumar, Manjula V ramsali, vankayapati Sarada Devi, Kulkarni Dilip Kumar,Pasapuleti surender. Fractionated d vs conventional method of drug administration in spinal anaesthesia for pregnant women undergoing caesarean section- a comparative study. .. 3. Nakul Srivastava , Pallavi Ahluwalia , G S Jheetay , Gurpartap Singh. Bolus dose versus fractionated dose injection of hyperbaric bupivacaine in spinal anaesthesia among adult patients undergoing lower limb surgery : A prospective study.
4. Pooja Derakhshan ,Seyed Hamid Rena Faiz,Poupak Rahimzadeh,Reza Salehi and Ghazaleh Khaled.A comparison of the effect of Fractionated and Bolus dose injection on Spinal anaesthesia for lower limb surgery : A randomised clinical trial |