| CTRI Number |
CTRI/2025/04/085387 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of femoral nerve block and intravenous fentanyl for ease of positioning during subarachnoid block for fracture neck femur surgeries A randomized comparative study |
|
Scientific Title of Study
|
Efficacy of femoral nerve block and intravenous fentanyl for ease of positioning during spinal Anesthesia for fracture neck femur surgeries: A randomized comparative 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 |
GOHIL PRANALI RAKESHBHAI |
| Designation |
Post graduate resident in anaesthesiology |
| Affiliation |
B.J. Medical College Ahmedabad |
| Address |
F3, First floor Department of Anaesthesiology Civil Hospital, Asarwa Ahmedabad, Gujarat
Ahmadabad
GUJARAT
380016
India |
| Phone |
9429857555 |
| Fax |
|
| Email |
pranaligohil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Seema Gandhi |
| Designation |
Associate Professor |
| Affiliation |
B.J. Medical College Ahmedabad |
| Address |
Department of Anaesthesia B.J. Medical College and Civil Hospital, Asarwa Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9426373192 |
| Fax |
|
| Email |
drseemagandhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Seema Gandhi |
| Designation |
Associate Professor |
| Affiliation |
B.J. Medical College Ahmedabad |
| Address |
Department of Anaesthesia B.J. Medical College and Civil Hospital, Asarwa Ahmedabad
Ahmadabad
GUJARAT
380016
India |
| Phone |
9426373192 |
| Fax |
|
| Email |
drseemagandhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| B.J. Medical College and Civil Hospital, Ahmedabad, 380016, Government of Gujarat, India |
|
|
Primary Sponsor
|
| Name |
B J Medical College and Civil Hospital Ahmedabad Government of Gujarat |
| Address |
7th floor, Health and family welfare department, Sachivalay,
Gandhinagar, 380016, India |
| 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 PRANALI RAKESHBHAI GOHIL |
B.J. Medical College and Civil Hospital, Ahmedabad |
Department of
Anaesthesia B.J.
Medical College,
Asarwa Ahmedabad,
Gujarat
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT |
9429857555
pranaligohil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee B.J. Medical College and Civil Hospital, Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Femoral nerve block |
All patients of this group will receieve femoral nerve block by landmark guided technique using 15 ml 1% Lignocaine 10 mins prior to positioning for Subarachnoid block |
| Comparator Agent |
Intravenous Fentanyl group |
All patients of this group will receive inj fentanyl 1 ug/kg intravenously 10 mins prior to positioning for Subarachnoid block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-75 years, Either gender, ASA Grade I, II, III, Unilateral fracture neck femur surgery under spinal anaesthesia, Written informed consent from patient, Patient able to understand VAS regarding assessment of pain
|
|
| ExclusionCriteria |
| Details |
Patient refusal, ASA Grade IV, V, Local infection at the site of lumbar puncture, Allergy to local anaesthetic agent or fentanyl, Patients having multiple fracture, Patients with neuromuscular disorder, coagulation disorder, H/o drug or alcohol abuse
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy of analgesia by assessing visual analogue score during positioning for subarachnoid block. |
Before analgesia,10 min after analgesia,During positioning |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe and compare hemodynamic changes, To observe any complication, in perioperative period
|
Before analgesia,10 min after analgesia,During positioning After Spinal Anaesthesia
15min,30min,60min,90min
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/05/2025 |
| 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="0"
Months="6"
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
|
Fracture femur is common orthopaedic presentation following trauma. It is extremely painful bone injury because periosteum has the lowest pain threshold of the deep somatic structures. The definitive management is to fix the fracture and spinal anaesthesia is preferred. The only concern is pain which may results in improper position for Subarachnoid block. Amongst analgesics, opioids are the gold standard out of which Fentanyl is preferred as it is more potent with rapid onset and short duration of action with less sedation, respiratory depression, nausea and histamine mediated itching as compared to other opioids.Regional anesthetic techniques have the theoretical advantage of avoiding the systemic effects of opioid analgesia, while providing analgesic that targets pain both at rest (static) and on movement (dynamic).Various peripheral nerve blocks have been used increasingly. Femoral nerve block is popular because it is safe and easy to perform. Being superficial nerve, landmarks are easily identifiable |