| CTRI Number |
CTRI/2026/03/105361 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
03/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find out which method of pain control works better after hip replacement surgery - Local infiltration analgesia( injecting pain medicine around the surgical area) or the PENG block ( a nerve block that numbs the nerves supplying the hip). |
|
Scientific Title of Study
|
To compare the analgesic efficacy of local infiltration analgesia (LIA)and pericapsular nerve group to (PENG) block for hip hemiarthroplasty |
| 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 M Rupinder Singh |
| Designation |
Professor |
| Affiliation |
Dayanand medical college and hospital ludhiana |
| Address |
Department of Anaesthesia Dayanand medical college and Hospital Civil Lines Ludhiana Punjab India
Ludhiana
PUNJAB
141001
India |
| Phone |
9814046459 |
| Fax |
|
| Email |
drmrupindersinghdmch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Khushpreet kaur |
| Designation |
PG resident Anaesthesia |
| Affiliation |
Dayanand medical college and hospital ludhiana |
| Address |
Department of Anaesthesia Dayanand medical college and Hospital Civil Lines Ludhiana Punjab India
Ludhiana
PUNJAB
141001
India |
| Phone |
9646409512 |
| Fax |
|
| Email |
drkhushpreetsidhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khushpreet kaur |
| Designation |
PG resident Anaesthesia |
| Affiliation |
Dayanand medical college and hospital ludhiana |
| Address |
Department of Anaesthesia Dayanand medical college and Hospital Civil Lines Ludhiana Punjab India
Ludhiana
PUNJAB
141001
India |
| Phone |
9646409512 |
| Fax |
|
| Email |
drkhushpreetsidhu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand medical college and hospital Ludhiana Tagore nagar ,Civil Lines Ludhiana 141001 Punjab India |
|
|
Primary Sponsor
|
| Name |
Dayanand medical college and hospital Ludhiana |
| Address |
Department of Anaesthesia Dayanand medical college and Hospital Tagore nagar ,Civil Lines Ludhiana 141001 Punjab India |
| 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 M Rupinder Singh |
DMCH Ludhiana |
Department of Anaesthesia Dayanand medical college and Hospital Tagore nagar Civil Lines Ludhiana 141001 Punjab India
Ludhiana
PUNJAB |
9814046459
drmrupindersinghdmch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethical committee ,Dayanand medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S720||Fracture of head and neck of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Local infiltration analgesia |
Type of local anaesthesia for post operative pain management |
| Intervention |
Pericapsular nerve group block |
Regional anaesthesia for post operative pain management |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
ASA I,II,III electively posted for hip hemiarthroplasty |
|
| ExclusionCriteria |
| Details |
Patient refusal
Known allergy to local anaesthetic
Contraindication to neuraxial blockade or peripheral nerve blocks
Chronic opioid use
Infection at site of block
Epidural requirement
BMI more than 35 kg/m2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be comparison of the total rescue analgesic consumption within 24 hours after hip surgery in patients given local infiltration analgesia or pericapsular nerve group (PENG) block in hip surgeries. |
After completion of the procedure, the patients will be shifted to post anaesthesia care unit (PACU) where postoperative vitals (HR, SBP, DBP, SpO2) along with VAS score at rest and sensory level of blockade will be monitored hourly for the first 4 hours, 2 hourly for the next 4 hours and then every 4 hourly till 24 hours post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time to first rescue analgesic as observed in either of the groups in the post operative period. Injection tramadol 50-100 mg I/V will be used as rescue analgesic whenever VAS more than 4 to a maximum of 400 mg within 24 hours following which if VAS is still more than 4 then another rescue analgesic, injection fentanyl 1mcg/kg IV as a slow bolus shall be administered to the patient.
2). Visual Analog Score (VAS) scale at the time, when the patient in either of the groups required rescue analgesic for pain relief. Postoperative pain will be measured using VAS pain scores within 24 hours in both the groups, where the score will be determined by asking the patient to rate the pain from 0-10 where a VAS score of 0 will indicate ‘no pain’ to VAS score of 10 indicating ‘worst pain’.
3). Overall patient satisfaction for pain management within 24 hours in both the groups through a 5-point Likert scale.
|
After completion of the procedure, the patients will be shifted to post anaesthesia care unit (PACU) where postoperative vitals (HR, SBP, DBP, SpO2) along with VAS score at rest and sensory level of blockade will be monitored hourly for the first 4 hours, 2 hourly for the next 4 hours and then every 4 hourly till 24 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 1 |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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
|
This study aims to compare the analgesic efficacy of Local Infiltration Analgesia (LIA) and Pericapsular Nerve Group (PENG) block in patients undergoing hip hemiarthroplasty. Postoperative pain after hip surgery is significant, and while opioids are effective, they are associated with adverse effects. Therefore, motor-sparing regional techniques like PENG block and LIA are increasingly used to reduce opioid consumption and enhance recovery.
The study will be a randomized, blinded observational trial involving 80 ASA I–III patients aged 18–80 years undergoing hip hemiarthroplasty under spinal anesthesia. Patients will be randomly allocated into two groups: Group P: Receiving ultrasound-guided PENG block Group L: Receiving intraoperative local infiltration analgesia (LIA)
All patients will receive standardized spinal anesthesia and postoperative multimodal analgesia. Pain will be assessed using the Visual Analog Scale (VAS).
Primary Outcome: Total rescue analgesic consumption within 24 hours postoperatively.
Secondary Outcomes: Time to first rescue analgesic VAS pain scores Overall patient satisfaction (5-point Likert scale)
Statistical analysis will compare analgesic consumption and pain scores between groups, with significance set at p < 0.05. The sample size is 80 patients (40 per group), calculated to achieve 95% confidence level and 95% power.
Conclusion: The study seeks to determine whether PENG block or LIA provides superior postoperative pain control and opioid-sparing effect in hip hemiarthroplasty patients, thereby contributing to improved recovery and patient satisfaction. |