| CTRI Number |
CTRI/2025/03/081756 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| 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
|
To determine which nerve block suits better for pain relief around hip joint in patients undergoing hip surgery |
|
Scientific Title of Study
|
A Randomized trial to compare the efficacy of pericapsula nerve group block and lumbar erector spinae plane block in patients with proximal 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 Shweta Mahajan |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical college |
| Address |
Department of Anaesthesiology,
Indira Gandhi Medical College,
Ridge Sanjauli Road, Lakkar Bazar, Shimla, Himachal Pradesh.
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418040187 |
| Fax |
|
| Email |
shwetamahajan437@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Mahajan |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical college |
| Address |
Department of Anaesthesiology,
Indira Gandhi Medical College,
Ridge Sanjauli Road, Lakkar Bazar, Shimla, Himachal Pradesh.
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418040187 |
| Fax |
|
| Email |
shwetamahajan437@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gaushik S |
| Designation |
Junior Resident |
| Affiliation |
Indira Gandhi Medical College |
| Address |
Department of Anaesthesiology,
Indira Gandhi Medical College,
Ridge Sanjauli Road, Lakkar Bazar, Shimla, Himachal Pradesh.
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
7339258987 |
| Fax |
|
| Email |
gaushiksiva@gmail.com |
|
|
Source of Monetary or Material Support
|
| Himachal Pradesh Government, City Shimla, India, Pin code 171001 |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College Shimla |
| Address |
Ridge Sanjauli Road, Lakkar Bazar, Shimla, Himachal Pradesh, India, 171001. |
| 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 Gaushik S |
Indira Gandhi Medical College, Shimla, Himachal Pradesh 171001 |
Department of
Anaesthesia,Ot
complex 5,6,7,8 ,Indira
Gandhi Medical
College,Ridge Sanjauli
road,Lakkar Bazaar
,Shimla ,171001
Shimla
HIMACHAL PRADESH |
7339258987
gaushiksiva@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Indira Gandhi Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S729||Unspecified fracture of femur, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lumbar Erector Spinae Plane Block with 0.5%bupivacaine 20 ml and Dexmedetomidine 100mcg ,total volume 21 ml |
The block is to be given in proximal femoral fracture patients 30 mins before administration of subarachnoid block. The observation period is 24 hours. The patient will be observed for post operative analgesia , mobilisation and overall satisfaction |
| Comparator Agent |
Pericapsular Nerve Group Block
with 0.5% bupivacaine 20 ml
and Dexmedetomidine 100 mcg
,total volume 21 ml |
The block is to be given in proximal femoral fracture patients 30 mins before administration of subarachnoid block. The observation period is 24 hours. The patient will be observed for post operative analgesia , mobilisation and overall satisfaction |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Radiologically confirmed cases of proximal femoral fractures both
intracapsular and extracapsular fractures in ASA I,ASAII and ASA III
patients. |
|
| ExclusionCriteria |
| Details |
-Patients who refuse to participate in the study.
-ASA grade IV
-Patients with known allergy to local anaesthetics.
-Patients with history of coagulopathy/ anticoagulant and antiplatelet
drugs.
-Patients with infection at the block site
-Polytrauma patients involving other fractures or head injury or in
shock
-Patients with history of peripheral neuropathy.
-Patients with history of psychiatric disease.
-Pregnant women |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of the pericapsular nerve group block and lumbar erector
spinae plane block in cases of proximal femur fracture surgeries by comparing the pre
and post block VAS scores. |
30 mins after the administration of nerve block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the duration of analgesic effects in the pericapsular nerve group block and
lumbar erector spinae plane block. |
24 hours |
| To compare the requirement for rescue analgesia in both groups. |
24 hours |
| To compare patient satisfaction and any side effects occurring in both groups |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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 4 |
|
Date of First Enrollment (India)
|
24/03/2025 |
| 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="1"
Months="0"
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
|
Although limited data available suggests that the use of Lumbar Erector Spinae plane block in the proximal femur surgeries for the post operative analgesia, the data is mostly in the form of case series and case reports. To establish the efficacy of the Lumbar Erector Spine Plane block further validation and research is needed. Therefore, we intend to compare the efficacy of the Lumbar Erector Spinae Plane Block with the Pericapsular Nerve Group Block in the patients with proximal femur surgeries for reducing the need for post operative analgesia and early post operative mobilization and try to make a total pain free environmentfor the patient both in the preoperative and postoperative period. |