| CTRI Number |
CTRI/2024/11/076358 [Registered on: 07/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare between two techniques of spinal anaesthesia - fractional and bolus injection - in elderly patients undergoing femur fracture surgery |
|
Scientific Title of Study
|
Comparison of fractionated dose versus bolus dose injection in spinal anaesthesia in elderly patients undergoing femur fracture surgery – A randomized 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 |
Dr Arun Parthasarathy |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9600129686 |
| Fax |
|
| Email |
p.arun1991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arun Parthasarathy |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9600129686 |
| Fax |
|
| Email |
p.arun1991@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arun Parthasarathy |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9600129686 |
| Fax |
|
| Email |
p.arun1991@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college and Kasturba hospital, Manipal, Karnataka - 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Arun Parthasarathy |
| Address |
Department of Anaesthesiology, Kasturba medical college and hospital, Manipal, Karnataka, India - 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 Arun Parthasarathy |
Kasturba Medical College and Kasturba hospital |
Department of Anaesthesiology, Manipal, 576104
Udupi
KARNATAKA |
9600129686
p.arun1991@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bolus dose injection in spinal anaesthesia |
Patients in this group will receive the entire drug mixture (total 2.4ml) as a bolus at the rate of 0.2ml/sec and will be made to sit for the next 60 seconds. Then the patient will be made to lie down. |
| Intervention |
Fractionated dose injection in spinal anaesthesia |
The total volume of the drug mixture for spinal anaesthesia is 2.4ml. Patients in this group will receive two-third of the drug mixture (1.6ml) initially, followed by the remaining one-third (0.8ml) of the drug mixture after a gap of 60 seconds. After injection of initial two third dose, the syringe will be kept attached to the spinal needle for remaining 60 s, after which remaining one third dose will be injected. The patient will be made to lie down after this. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Elective femur fracture surgery, Age more than 60 years, ASA PS 1,2,3, Surgery planned under spinal anaesthesia
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Absolute contraindications for spinal anaesthesia |
|
|
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 the hemodynamic stability between fractionated and bolus dose injection in spinal anaesthesia |
Every 3 minutes for the initial 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time of onset and duration of sensory block
To compare the time of onset and duration of motor block
To compare the maximum level of sensory block achieved
|
Every 5 minutes for the initial 20 minutes |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="118" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
18/11/2024 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
The geriatric population, irrespective of the type of surgery they undergo, poses a challenge for the anaesthesiologists. This is attributed to the reduced functional reserve in the elderly, associated multiple comorbidities and frail nature. Elderly patients with femur fractures usually add to this challenge as they may present late to the hospital for their treatment, which increases the risk of perioperative adverse outcomes. Generally, spinal anaesthesia (SA) is commonly employed for lower limb surgeries. Its advantages are simple to perform, good analgesia, reduced blood loss and so on. But the sympatholysis produced by spinal anaesthesia when given as a bolus dose of local anaesthetics can lead to profound hypotension, which may not be tolerated by the elderly patients. This hypotension can predispose patients to have end organ damage, which contributes to the overall morbidity. Rate of injection is one of the factors determing the level of spinal block and incidence of hypotension. Fractionated dose of local anaesthetic in spinal anaesthesia is administering two-thirds of the total calculated dose initially following which the remaining one-third dose is given after a gap of 45 to 90 sec between the injections. This method has been shown to provide better hemodynamic stability and longer duration of analgesia.
The study was completed successfully. Recruitment and follow-up were completed as per protocol. Data analysis has been completed |