| CTRI Number |
CTRI/2025/05/086170 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
01/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the pain perception of participants to three different methods of local anesthesia used for platelet rich plasma injection for hair loss |
|
Scientific Title of Study
|
An open labelled prospective comparative study on pain perception and patient acceptance of three routes of administration of local anaesthesia in platelet-rich-plasma procedure for hair growth |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muhammed Razmi T |
| Designation |
Consultant Dermatologist |
| Affiliation |
IQRAA International Hospital and Research Centre |
| Address |
Dr Afraz ZIVA Skin Hair Clinic, Thana Post, Kannur 12, Kerala 670012
IQRAA Aesthetics, IQRAA International Hospital and Research Centre, Address Mall, Calicut, Kerala, India, Pin 673001
Kozhikode
KERALA
670012
India |
| Phone |
918891866466 |
| Fax |
|
| Email |
dr.razmi.t@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Muhammed Razmi T |
| Designation |
Consultant Dermatologist |
| Affiliation |
IQRAA International Hospital and Research Centre |
| Address |
Dr Afraz ZIVA Skin Hair Clinic, Thana Post, Kannur 12, Kerala 670012
IQRAA Aesthetics, IQRAA International Hospital and Research Centre, Address Mall, Calicut, Kerala, India, Pin 673001
KERALA
670012
India |
| Phone |
918891866466 |
| Fax |
|
| Email |
dr.razmi.t@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Muhammed Razmi T |
| Designation |
Consultant Dermatologist |
| Affiliation |
IQRAA International Hospital and Research Centre |
| Address |
Dr Afraz ZIVA Skin Hair Clinic, Thana Post, Kannur 12, Kerala 670012
IQRAA Aesthetics, IQRAA International Hospital and Research Centre, Address Mall, Calicut, Kerala, India, Pin 673001
KERALA
670012
India |
| Phone |
918891866466 |
| Fax |
|
| Email |
dr.razmi.t@gmail.com |
|
|
Source of Monetary or Material Support
|
| IADVL Kerala Research Grant 2025 |
| IQRAA Aesthetics, IQRAA International Hospital and Research Centre, Address Mall, Calicut, Kerala, India, Pin 673001 |
|
|
Primary Sponsor
|
| Name |
Muhammed Razmi T |
| Address |
Dr Afraz ZIVA Skin Hair Clinic, Thana Post, Kannur 670012, Keral |
| Type of Sponsor |
Other [Self] |
|
|
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 Muhammed Razmi T |
IQRAA International Hospital and Research Centre |
Department of Dermatology & Cosmetology, Room No.1 ; IQRAA Aesthetics, Address Mall, Calicut, Kerala, India, Pin 673001
Kozhikode
KERALA |
00918891866466
dr.razmi.t@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IQRAA International Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Method of nerve blocks |
Supraorbital and supratrochlear nerve blocks (SON and STN) will be used. Under sterile precautions 1-2 mL of LA medication is injected in the subcutaneous plane using an insulin syringe corresponding to the surface marking of each nerve. STN block was given slightly above the eyebrow across its medial border, injecting 1mL of 2% lignocaine with 1:200000 adrenaline to anesthetize the area. SON block was given 2 cm lateral from the point of injection for the STN block using the same amount of local anesthesia. PRP injection is started after 10-20 minutes of nerve block depending upon the actuation of anesthesia. |
| Intervention |
Method of nerve blocks |
Supraorbital and supratrochlear nerve blocks (SON and STN) will be used. Under sterile precautions 1-2 mL of LA medication is injected in the subcutaneous plane using an insulin syringe corresponding to the surface marking of each nerve. STN block was given slightly above the eyebrow across its medial border, injecting 1mL of 2% lignocaine with 1:200000 adrenaline to anesthetize the area. SON block was given 2 cm lateral from the point of injection for the STN block using the same amount of local anesthesia. PRP injection is started after 10-20 minutes of nerve block depending upon the actuation of anesthesia. |
| Comparator Agent |
Method of nerve blocks |
Supraorbital and supratrochlear nerve blocks (SON and STN) will be used. Under sterile precautions 1-2 mL of LA medication is injected in the subcutaneous plane using an insulin syringe corresponding to the surface marking of each nerve. STN block was given slightly above the eyebrow across its medial border, injecting 1mL of 2% lignocaine with 1:200000 adrenaline to anesthetize the area. SON block was given 2 cm lateral from the point of injection for the STN block using the same amount of local anesthesia. PRP injection is started after 10-20 minutes of nerve block depending upon the actuation of anesthesia. |
| Comparator Agent |
Method of scalp ring block with local anesthesia infiltration |
Scalp ring block is achieved by infiltrating local anesthesia circumferentially around the fronto-parieto-vertex scalp bald area. A total of 4-5mL of 2% lignocaine with 1:200000 adrenaline is used to anesthetize parieto-vertex scalp bald area. Each ml is used to locally infiltrate into the subcutaneous plane along anterior border, both lateral border and posterior border, 2cm outside the margin of balding area. An extra 1mL is used for people with wide scalp area. PRP injection is started after 10-20 minutes of nerve block depending upon the actuation of anesthesia. |
| Comparator Agent |
Method of scalp ring block with local anesthesia infiltration |
Scalp ring block is achieved by infiltrating local anesthesia circumferentially around the fronto-parieto-vertex scalp bald area. A total of 4-5mL of 2% lignocaine with 1:200000 adrenaline is used to anesthetize parieto-vertex scalp bald area. Each ml is used to locally infiltrate into the subcutaneous plane along anterior border, both lateral border and posterior border, 2cm outside the margin of balding area. An extra 1mL is used for people with wide scalp area. PRP injection is started after 10-20 minutes of nerve block depending upon the actuation of anesthesia. |
| Intervention |
Method of scalp ring block with local anesthesia infiltration |
Scalp ring block is achieved by infiltrating local anesthesia circumferentially around the fronto-parieto-vertex scalp bald area. A total of 4-5mL of 2% lignocaine with 1:200000 adrenaline is used to anesthetize parieto-vertex scalp bald area. Each ml is used to locally infiltrate into the subcutaneous plane along anterior border, both lateral border and posterior border, 2cm outside the margin of balding area. An extra 1mL is used for people with wide scalp area. PRP injection is started after 10-20 minutes of nerve block depending upon the actuation of anesthesia. |
| Intervention |
Method of topical anesthesia spray |
Lignocain 10% spray is used for topical anesthesia. Scalp is cleaned with povidone iodine solution and dried. Adequate amount of lidocaine spray to cover entire area of injection applied and spread onto the surface. Scalp covered with a sterile disposable surgeon’s cap for 30 min before the procedure. |
| Comparator Agent |
Method of topical anesthesia spray |
Lignocain 10% spray is used for topical anesthesia. Scalp is cleaned with povidone iodine solution and dried. Adequate amount of lidocaine spray to cover entire area of injection applied and spread onto the surface. Scalp covered with a sterile disposable surgeon’s cap for 30 min before the procedure. |
| Comparator Agent |
Method of topical anesthesia spray |
Lignocain 10% spray is used for topical anesthesia. Scalp is cleaned with povidone iodine solution and dried. Adequate amount of lidocaine spray to cover entire area of injection applied and spread onto the surface. Scalp covered with a sterile disposable surgeon’s cap for 30 min before the procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age more than 18 years and less than 60 years of either gender seeking PRP treatment for hair fall for any indication consenting to participate in study |
|
| ExclusionCriteria |
| Details |
patients of age less than 18 years, patients who were not willing to participate in study and patients with complete hair loss were excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the impact of topical local anaesthesia versus local anaesthetic infiltration either as Supraorbital and Supratrochlear nerve block or peripheral ring shaped field block in reducing the pain during PRP treatment and to assess the patient’s acceptance of these methods |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know the reason behind the patient’s acceptance of different methods so as to customize the different anesthetic techniques in clinical practice based on patient’s preference |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
15/05/2025 |
| 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 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
|
Background
Platelet-rich plasma (PRP) is
a safe and proven method for hair regrowth. However, pain during PRP injection
is unacceptable to most of the patients. An effective method of local anaesthesia
administration is needed to alleviate pain during the procedure. Though there are studies that employed local
anaesthesia either topically or by infiltration to reduce the pain, to the best
of our knowledge, no study has compared both. The results of this study may
guide dermatologists to perform PRP treatment with better patient comfort.
Objective
To compare the impact of
topical local anaesthesia versus local anaesthetic infiltration either as frontal
supraorbital and supratrochlear nerve block or peripheral ring shaped field
block in reducing the pain during PRP treatment and to assess the patient’s
acceptance of these methods. |