CTRI

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CTRI Number

CTRI/2021/11/038334 [Registered on: 30/11/2021] Trial Registered Prospectively

Last Modified On:

29/11/2021

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Diagnostic

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparative study between femoral nerve block versus pericapsular nerve group block for pain in proximal femoral fractures during anesthesia positioning

Scientific Title of Study

COMPARATIVE STUDY OF PERICAPSULAR NERVE GROUP BLOCK VERSUS FEMORAL BLOCK WITH ULTRASOUND GUIDANCE FOR ANALGESIA OF POSITIONAL PAIN IN PROXIMAL FEMORAL FRACTURES

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr AKASH BABU
Designation	Junior Resident
Affiliation	Sree Balaji Medical College and Hospital
Address	Sree Balaji Medical College And Hospital No .7 CLC works road Chrompet Chennai TAMIL NADU 600044 India
Phone	9043739347
Fax
Email	Akashyadhu@gmail.com

Details of Contact Person
Scientific Query

Name	Vinod
Designation	Professor
Affiliation	Sree Balaji Medical College and Hospital
Address	Sree Balaji Medical College And Hospital No .7 CLC works road Chrompet Chennai TAMIL NADU 600044 India
Phone	9841557566
Fax
Email	vinodkrishnagopal@gmail.com

Details of Contact Person
Public Query

Name	Dr AKASH BABU
Designation	Junior Resident
Affiliation	Sree Balaji Medical College and Hospital
Address	Sree Balaji Medical College And Hospital No .7 CLC works road Chrompet TAMIL NADU 600044 India
Phone	9043739347
Fax
Email	Akashyadhu@gmail.com

Source of Monetary or Material Support

Sree Balaji Medical College and hospital

Primary Sponsor

Name	Sree Balaji Medical College and hospital
Address	No 7, CLC works road, Chrompet Chennai
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
DrAkash	Sree Balaji medical College and Hospital	Department of anesthesia Sree balaji medical college and hospital, 3 star operation theatre Number 7,CLC Works Road, Chrompet Chennai TAMIL NADU	9043739347 akashyadhu@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Human Ethical Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	, (1) ICD-10 Condition: O\|\|Medical and Surgical,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Pericapsular nerve group block versus femoral block	Under ultrasound guidance with 10 ML of 2% lignocaine place 0.5% bupivacaine will be given 20mis prior to positioning the patient for spinal anaesthesia
Comparator Agent	Pericapsular nerve group block versus femoral nerve block	Comparison of efficiency of both blocks in pain relief and hemodynamic stability and comfort of the patient while positioning them for spinal anesthesia in proximal femoral fracture patients .

Inclusion Criteria

Age From	15.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	All patients undergoing lower limb surgery at Sree Balaji Medical College and Hospital 1. ASA grade - l, ll, lll 2. Patients posted for proximal femoral fracture 3. Patients posted for elective surgeries

ExclusionCriteria

Details

1. Patient refusal
2. ASA grade lV
3. Morbidly obese patient
4. Known case of hypersensitivity reaction to local anaesthetics.
5. Bleeding diathesis, peripheral neuropathy and psychiatric disorder.
6. Local infection at the site of puncture.
7. Patients with polytrauma.
8. Previous femoral bypass surgeries

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Investigator Blinded

Primary Outcome

Outcome	TimePoints
To find which block patience provides more analgesia, haemodynamic status and ease of the patient while positioning the patient for spinal anaesthesia.	Till positioning of the patient for spinal anesthesia

Secondary Outcome

Outcome	TimePoints
Comparing the efficacy of two blocks	From the time of performing the block Till positioning of the patient

Target Sample Size

Total Sample Size="50"
Sample Size from India="50"
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)

01/12/2021

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 Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Nil

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

This is a comparative study, to be done in total number of 50 patients who are undergoing proximal femur fracture surgeries at Department of Anaesthesiology PM &CC,Sree Balaji medical College and Hospital, Chennai.

After confirming to the inclusion and exclusion criteria, patients will be selected consecutively and Assigned alternatively to either of the two groups. The first group shall undergo USG guided pericapsular nerve group block and the second group shall undergo USG guided femoral nerve block with 10ml of 2% lignocaine plus 0.5% bupivacaine. Both the groups The procedure under USG guidance 20 minutes prior to positioning the patient for spinal anaesthesia. The quality of patients positioning during the spinal anesthesia was graded according to the scale( 1- satisfactory,2- good 3-optimal) and was recorded. Pain status will be assessed by numerical rating pain score before, after and while positioning the patient for spinal anesthesia. The hemodynamic status of the patients will be recorded throughout the whole process.