| CTRI Number |
CTRI/2025/11/097105 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
07/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Two Nerve Blocks (PENG and Fascia Iliaca) to Reduce Pain and Help Patients with Hip Fractures Sit Comfortably for Spinal Anesthesia |
|
Scientific Title of Study
|
Comparison of PENG Block and Suprainguinal Fascia Iliaca Block for Facilitating Positioning in Hip Fracture Surgeries for Spinal Anesthesia: A Randomized Controlled 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 |
Neha Sharma |
| Designation |
Assistant Professor |
| Affiliation |
United Institute of Medical Sciences, Prayagraj |
| Address |
Department of Anesthesiology, Second Floor, United Institute of Medical Sciences, Rawatput, Jhalwa, Prayagraj
Allahabad
UTTAR PRADESH
211012
India |
| Phone |
8928270807 |
| Fax |
|
| Email |
doc.sharmaneha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neha Sharma |
| Designation |
Assistant Professor |
| Affiliation |
United Institute of Medical Sciences, Prayagraj |
| Address |
Department of Anesthesiology, Second Floor, United Institute of Medical Sciences, Rawatput, Jhalwa, Prayagraj
Allahabad
UTTAR PRADESH
211012
India |
| Phone |
8928270807 |
| Fax |
|
| Email |
doc.sharmaneha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neha Sharma |
| Designation |
Assistant Professor |
| Affiliation |
United Institute of Medical Sciences, Prayagraj |
| Address |
Department of Anesthesiology, Second Floor, United Institute of Medical Sciences, Rawatput, Jhalwa, Prayagraj
Allahabad
UTTAR PRADESH
211012
India |
| Phone |
8928270807 |
| Fax |
|
| Email |
doc.sharmaneha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
United Institute of Medical Sciences |
| Address |
Department of Anesthesiology, Second Floor, United Institute of Medical Sciences, Rawatput, Jhalwa, Prayagraj 211012 |
| 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 Neha Sharma |
United Institute of Medical Sciences |
Department of Anesthesiology, Second Floor, United Institute of Medical Sciences, Rawatput, Jhalwa, Prayagraj 211012
Allahabad
UTTAR PRADESH |
8928270807
doc.sharmaneha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-UIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M259||Joint disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Peri Encapsular Nerve Block (PENG) |
Under ultrasound guidance, a PENG block will be performed using 20 mL of 0.2% Ropivacaine. The needle will be placed in the plane between the psoas tendon and the pubic ramus to deposit the local anesthetic near the articular branches of the femoral and accessory obturator nerves.
Timing: Single administration before attempting positioning for spinal anesthesia.
Duration: Once-only procedure prior to spinal anesthesia. The total duration of the intervention, including patient preparation, ultrasound-guided block performance, and onset of analgesia assessment, is approximately 20–25 minutes. |
| Comparator Agent |
Supra Inguinal Fascia Iliaca Block (SIFI) |
Under ultrasound guidance, a suprainguinal fascia iliaca block will be performed using 20 mL of 0.2% Ropivacaine. The local anesthetic will be injected in the potential space between the fascia iliaca and the iliacus muscle, just above the inguinal ligament, to block the femoral, lateral femoral cutaneous, and obturator nerves.
Timing: Single administration before attempting positioning for spinal anesthesia.
Duration: Once-only procedure prior to spinal anesthesia. The total duration of the intervention, including patient preparation, ultrasound-guided block performance, and onset of analgesia assessment, is approximately 20–25 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed with unilateral hip fracture requiring surgery under spinal anesthesia
2.ASA Physical Status I–III
3.Ability to understand and consent to the procedure
|
|
| ExclusionCriteria |
| Details |
1.Local infection at the block site
2.Known allergy to local anesthetics
3.Coagulopathy or anticoagulant use contraindicating regional blocks
4.Altered sensorium or inability to comprehend NRS
5.Pre-existing neuropathies or chronic opioid use
•Multiple fractures or polytrauma
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Pain score during positioning for spinal anesthesia |
Numerical Rating Scale 0-10 before block, 15 min post block and at the time of positioning |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Time to optimal positioning
•Change in pain scores
•Block onset time
•Ease of positioning
•Hemodynamic changes
•Complications
|
1.Time from end of block to readiness for spinal (defined by ability to sit or lateral position without assistance and minimal discomfort)
2.Change in pain scores at:
oBefore block (Baseline)
o15 minutes post-block
oAt the time of spinal positioning
3.Time from block completion to first clinically observed pain relief
4.Ease of positioning: Graded by observer (1: Not possible, 2: With difficulty, 3: Comfortable)
5.HR and BP monitored at baseline, 5, 10, 15, and 30 minutes
6.Complications: Local anesthetic toxicity, vascular puncture, motor weakness, infection |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
18/11/2025 |
| 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="9"
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
|
Hip fracture surgeries in elderly patients often require spinal anesthesia, but positioning these patients for the procedure can be extremely painful due to fracture-related discomfort. Adequate regional analgesia before positioning improves patient comfort and facilitates successful spinal anesthesia. This randomized controlled trial aims to compare the efficacy of Pericapsular Nerve Group (PENG) block and Suprainguinal Fascia Iliaca (SIFI) block in improving patient comfort during positioning for spinal anesthesia in hip fracture surgeries. Sixty patients scheduled for hip fracture surgery under spinal anesthesia will be randomly allocated into two equal groups to receive either a PENG block or a SIFI block using 20 mL of 0.2percent Ropivacaine under ultrasound guidance. The primary outcome will be the pain score during positioning for spinal anesthesia. Secondary outcomes will include the time for optimal positioning, change in pain scores at baseline, 15 minutes and at the time for optimal positioning, the block onset time, ease of positioning, hemodynamic changes and any noted complications. This study aims to identify which of the two regional anesthesia techniques provides superior analgesia and facilitates optimal patient positioning for spinal anesthesia in hip fracture surgeries. |