| CTRI Number |
CTRI/2024/03/063578 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Pericapsular Nerve Group (PENG) Block in enhancing recovery after surgery |
|
Scientific Title of Study
|
Role of Pericapsular Nerve Group (PENG) block for Enhanced Recovery After Surgery (ERAS) for femur fracture 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 Ruchi Gupta |
| Designation |
Professor and head |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research, Amritsar |
| Address |
Department of Anaesthesia, Sri guru Ram Das Institute of Medical Sciences and Research, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9814020805 |
| Fax |
|
| Email |
drruchisgrd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harpreet Babrah |
| Designation |
Assistant Professor |
| Affiliation |
Sri guru Ram Das Institute of Medical Sciences and Research, Amritsar |
| Address |
Department of Anaesthesia, Sri guru Ram Das Institute of Medical Sciences and Research, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9023448624 |
| Fax |
|
| Email |
docharpreet21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Monica Kaur |
| Designation |
Junior Resident |
| Affiliation |
Sri guru Ram Das Institute of Medical Sciences and Research, Amritsar |
| Address |
Department of Anaesthesia, Sri guru Ram Das Institute of Medical Sciences and Research, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
8872337999 |
| Fax |
|
| Email |
monica120495@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute of Medical Sciences and research |
| Address |
Mehta Road, Vallah,Amritsar |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ruchi Gupta |
Main Operation Theatre |
Department of Anaesthesia, Sri Guru Ram Das Institute of medical; Sciences and Research, Amritsar
Amritsar
PUNJAB |
9814020805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PENG block and Pre procedure IV Injection tramadol 2mg/kg |
PENG block and Pre procedure IV Injection tramadol 2mg/kg will be given 15 minutes prior and the surgery will be performed under spinal anaesthesia |
| Intervention |
PENG block will be given 15 minutes prior and the surgery will be performed under spinal anaesthesia
|
PENG block will be performed in supine position with procedural leg slightly abducted and prepared with povidone-iodine solution. Mild sedation may be administered (midazolam: 0.05mg/kg intravenously). Using aseptic technique, a curvilinear low frequency ultrasound probe is placed on a transverse plane over anterior superior iliac spine ASIS) and then rotated approximately 45 degrees to be aligned with pubic ramus. The transducer will then be slid medially along the axis until anterior inferior iliac spine (ASIS), psoas tendon and iliopubic eminence (IPE) is identified; Thus, serving as anatomical landmarks. A 22 gauge 100 mm needle is inserted in -plane, from lateral to medial between psoas tendon and pubic ramus. 20 ml of 0.5% levobupivacaine is deposited in this plane, lifting the psoas tendon. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with femur fracture
2) ASA grade I, II |
|
| ExclusionCriteria |
| Details |
1) Lack of patient’s consent
2) Skin infection at site of injection
3) Allergic to drugs used
4) Patients suffering from bleeding diathesis or coagulation disorders
5) Cognitive impairment
6) Neuromuscular disorder
7) Patients being treated with anticoagulants or antithrombotic medications |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of recovery score |
Post-surgery arrival to post-anaesthesia care unit and discharge after 24 hours. Postoperative observation in the ward till 48 hours.
Then at the time of discharge from hospital. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Time to first request for analgesic following spinal anaesthesia postoperatively
2) Quadriceps power during first 24 hours post surgery
3) Postoperative dynamic pain control
4) Time of mobilisation and resumption of normal activities
5) Length of hospital stay |
From post anaesthesia care unit to discharge from hospital |
|
|
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)
|
20/03/2024 |
| 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="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
|
BACKGROUND: ERAS (Enhanced Recovery After Surgery) is a fast track program to boost the outcome of recovery after surgery. For orthopaedic procedures, peripheral blocks have been recommended for ERAS. The pericapsular nerve group (PENG) block is a regional anaesthesia technique that targets the nerves supplying the anterior capsule of hip with an additional advantage of motor sparing of quadriceps muscle. We plan to conduct a study to evaluate the role of PENG block for ERAS for orthopaedic procedures. MATERIAL AND METHOD: Patients will be randomly allocated into one of the two groups of 30 patients each. Group A: Prepocedure PENG block will be given 15 minutes prior and the surgery will be performed under spinal anaesthesia. Group B: Preprocedure IV Injection tramadol 2mg/kg will be given 15 minutes prior and the surgery will be performed under spinal anaesthesia STATISTICAL ANALYSIS: Thus, data will be compiled and statistically analysed |