| CTRI Number |
CTRI/2025/06/088558 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A prospective randomized study to compare the effect of fractionated versus bolus dose of Injection 0.5% bupivacaine and fentanyl in spinal anaesthesia for lower extremities orthopaedic surgery |
|
Scientific Title of Study
|
"A PROSPECTIVE RANDOMIZED STUDY TO COMPARE THE EFFECT OF FRACTIONATED VERSUS BOLUS DOSE OF INJECTION 0.5% BUPIVACAINE AND FENTANYL IN SPINAL ANAESTHESIA FOR LOWER EXTREMITIES ORTHOPAEDIC SURGERY." |
| 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 Ashwini solanki |
| Designation |
PG Resident |
| Affiliation |
Gajra Raja Medical College Gwalior |
| Address |
Department of anaesthesiology, Gajara Raja medical College, Gwalior
India
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9179285065 |
| Fax |
|
| Email |
ashwinisolanki2015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neelima tandon |
| Designation |
Professor |
| Affiliation |
Gajra Raja Medical College |
| Address |
Department of Anaesthesiology, Gajra Raja Medical College,Gwalior Madhya Pradesh
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9826215586 |
| Fax |
|
| Email |
dr.neelimatandon21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelima tandon |
| Designation |
Professor |
| Affiliation |
Gajra Raja Medical College |
| Address |
Department of Anaesthesiology, Gajra Raja Medical College,Gwalior Madhya Pradesh
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9826215586 |
| Fax |
|
| Email |
dr.neelimatandon21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gajra Raja Medical College,Department of Anaesthsiology, 474009 Gwalior Madhya Pradesh INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Ashwini solanki |
| Address |
Deparment of Anaesthesiology, Gajra Raja medical College, Gwalior Madhya Pradesh 474009 |
| Type of Sponsor |
Government 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 Ashwini solanki |
Gajra Raja Medical College Gwalior and 1000 bedded JAH hospital gwalior M.P. |
Department of Anaesthesiology Gajra Raja Medical College Gwalior
Gwalior
MADHYA PRADESH |
9179285065
ashwinisolanki2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee , gajra raja medical college, Gwalior |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S723||Fracture of shaft of femur, (2) ICD-10 Condition: S729||Unspecified fracture of femur, (3) ICD-10 Condition: S823||Fracture of lower end of tibia, (4) ICD-10 Condition: S822||Fracture of shaft of tibia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bolus dose of injection 0.5% Hyperbaric Bupivacaine with 25mcg fentanyl in spinal anaesthesia for lower limb surgeries |
Bolus dose group will receive total dose of 15 mg o.5% hyperbaric Bupivacaine with 25mcg fentanyl intrathically at the rate of 0.2ml /sec |
| Intervention |
Fractionated dose of injection 0.5% hyperbaric bupivacaine with 25 mcg fentanyl in spinal anaesthesia for lower limb surgeries |
Fractionated dose group will receive intially 2/3rd of total dose of 15mg 0.5% Hyperbaric Bupivacaine with 25mcg fentanyl intrathically at the rate of 0.2ml/sec and 1/3rd dose will receive after 90 se at same rate intrathically |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing lower limb surgeries.
Age between 18 to 60 years ,ASA grade I and II
|
|
| ExclusionCriteria |
| Details |
Age less than 18 years of age and more than 60 years
Patient refusal
ASA III & IV
Infection at the site of injection
Patient having hereditary coagulopathy, raised ICT, severely altered mental status, spinal deformities, aortic stenosis, BMI more than 35 kg/m2 and thromboprophylaxis, allergy to spinal anaesthesia |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Expected early onset of sensory and motor blockage and prolonged duration of analgesia and more hemodynamic stability in fractionated dose group |
24 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Expected better post operative analgesia and lesser side-effects |
24 Hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/06/2025 |
| 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 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
|
This is a prospective comparitive study comparing fractionated versus bolus dose of injection 0.5% hyperbaric bupivacaine with fentanyl in spinal anaesthesia for lower limb surgeries.In this study we are comparing sensory blockage,motor blockage,post operative analgesia, hemodynamic changes and adverse effects in both group. |