| CTRI Number |
CTRI/2023/04/052079 [Registered on: 27/04/2023] Trial Registered Prospectively |
| Last Modified On: |
27/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the efficacy of Pericapsular Nerve Group (PENG) Block versus Supra-Inguinal Fascia Iliaca (SIFI) Block for post-operative pain relief in hip surgeries. |
|
Scientific Title of Study
|
Comparison of Pericapsular Nerve Group (PENG) Block versus Supra-Inguinal Fascia Iliaca (SIFI) Block for post-operative analgesia in Hip surgeries. |
| Trial Acronym |
|
|
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 Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Tagore Nagar Ludhiana PUNJAB 141001 India |
| Phone |
9814046459 |
| Fax |
|
| Email |
drmrupindersinghdmch@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Tanusha Saini |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Tagore Nagar Ludhiana PUNJAB 141001 India |
| Phone |
6239510393 |
| Fax |
|
| Email |
tanushasaini01@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Tanusha Saini |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Tagore Nagar Ludhiana PUNJAB 141001 India |
| Phone |
6239510393 |
| Fax |
|
| Email |
tanushasaini01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital, Ludhiana. |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital |
| Address |
Civil Lines, Tagore Nagar, Ludhiana, Punjab, India. 141001 |
| 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 |
Dayanand Medical College and Hospital |
Department of Anaesthesia, Dayanand Medical College and Hospital, Civil Lines, Tagore Nagar, Ludhiana 141001. Ludhiana PUNJAB |
9814046459
drmrupindersinghdmch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethics Committee, Dayanand Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pericapsular Nerve Group (PENG) Block for postoperative analgesia in Hip surgeries |
Patients in group A will receive an ultrasound-guided Pericapsular Nerve Group (PENG) Block with 30ml of 0.2% Ropivacaine and 4mg and dexamethasone. Post-operative pain will be measured using VAS pain scores at 24 hours at rest. |
| Comparator Agent |
Supra Inguinal Fascia iliaca (SIFI) Block for postoperative analgesia in Hip surgeries |
Patients in group B will receive an ultrasound-guided Supra Inguinal Fascia Iliaca (SIFI) Block with 30ml of 0.2% Ropivacaine and 4mg dexamethasone. Post-operative pain will be measured using VAS pain scores at 24 hours at rest. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged 40-85 years of age
2. ASA Physical status I, II, III
3. Electively scheduled for hip surgeries.
4. Body mass index between 18-35 kg/m2
|
|
| ExclusionCriteria |
| Details |
1. Known allergy to study drugs
2. Contraindication to neuraxial blockade or
peripheral nerve blocks
3. Chronic opioid use
4. Diabetic neuropathy
5. Infection at the site of block
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| For PRIMARY OUTCOME: Postoperative pain will be measured using VAS pain scores at 24 hours at rest in both the groups. |
The patients 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 |
For SECONDARY OUTCOMES:
• functional mobility will be
assessed by assessing
quadriceps muscle strength
by Manual Muscle Testing
scale and maximum weight-
bearing possible at 24 hours
and 48 hours post-
operatively.
• time for first rescue
analgesia.
• total opioid consumption in
first 24 hours.
• overall patient satisfaction
for pain management within
24 hours in both the groups.
• surgeon’s satisfaction to
anaesthesia services for
overall pain management post
operatively.
|
Functional mobility and weight bearing will be measured at 24 and 48 hours. |
|
|
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)
|
10/05/2023 |
| 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="6" Days="29" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Hip procedures are common orthopedic surgeries performed routinely and are associated with significant amount of pain. Adequate analgesia is very crucial post-operatively to enhance dynamic pain relief, early patient recovery, reduced hospital stay, prevention of readmissions along with overall improved patient satisfaction to recovery. Peripheral nerve blocks have the advantage of potent analgesia, minimal systemic complications which are associated with central neuraxial blockades and less motor blockade, therefore leading to early patient recovery and overall better outcomes. A prospective, double-blinded randomized study will be conducted on 60 adult patients, ASA- I to III undergoing orthopedic surgeries for hip fractures, under sub-arachnoid block in which they will be randomly allocated to either group A which will receive 30ml of 0.2% Ropivacaine with 4mg dexamethasone USG-guided pericapsular nerve group (PENG) block or to group B which will receive 30ml of 0.2% Ropivacaine with 4mg dexamethasone USG-guided supra-inguinal fascia iliaca (SIFI) block. The primary outcome is comparing VAS scores at rest at 24 hours in both the groups. The secondary outcome is functional mobility at 24 and 48 hours postoperatively by assessing the quadriceps muscle strength, maximum weight bearing possible at 24 hours and 48 hours post-operatively, time to need for first rescue analgesia, total opioid consumption in first 24 hours along with overall patient satisfaction to recovery and surgeon’s satisfaction to overall pain management in both the groups. |