| CTRI Number |
CTRI/2025/06/089560 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
21/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Reducing Pain from Propofol Injection: A Comparison of Two Lignocaine Treatments in Adults |
|
Scientific Title of Study
|
TO COMPARE 15 ML OF 0.4% LIGNOCAINE VERSUS 3ML OF 2% LIGNOCAINE FOR PREVENTING PAIN ASSOCIATED WITH PROPOFOL INJECTION |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumbul Ansa |
| Designation |
Junior Resident 2 |
| Affiliation |
Government Medical Haldwani |
| Address |
Depatment of Anaesthesiology, critical care, pain and palliative medicine, 2nd
floor susheela tiwari hospital, Haldwani
Nainital
UTTARANCHAL
263139
India
Nainital
UTTARANCHAL
263139
India |
| Phone |
9536849993 |
| Fax |
|
| Email |
sumbulansa321@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar Sinha |
| Designation |
Professor and HOD ,Department of Anaesthesiology |
| Affiliation |
Government Medical Haldwani |
| Address |
Depatment of Anaesthesiology, critical care, pain and palliative medicine, 2nd
floor susheela tiwari hospital, Haldwani
Nainital
UTTARANCHAL
263139
India
Nainital
UTTARANCHAL
263139
India |
| Phone |
9897672301 |
| Fax |
|
| Email |
drajayksinha@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar Sinha |
| Designation |
Professor and HOD ,Department of Anaesthesiology |
| Affiliation |
Government Medical Haldwani |
| Address |
Depatment of Anaesthesiology, critical care, pain and palliative medicine, 2nd
floor susheela tiwari hospital, Haldwani
Nainital
UTTARANCHAL
263139
India
Nainital
UTTARANCHAL
263139
India |
| Phone |
9897672301 |
| Fax |
|
| Email |
drajayksinha@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, critical care, pain and palliative medicine ,Susheela Tiwari Government Hospital, Haldwani, Uttarakhand, 263139 |
|
|
Primary Sponsor
|
| Name |
Dr Sumbul Ansa |
| Address |
Department of Anaesthesiology, critical care ,pain and palliative medicine, Susheela Tiwari Government Hospital, Haldwani, Uttarakhand, 263139 |
| 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 Sumbul Ansa |
Susheela Tiwari Government Hospital |
Department of Anaesthesiology, critical care , pain and palliative medicine, Susheela Tiwari Government Hospital, Haldwani, Uttarakhand,263139
Nainital
UTTARANCHAL |
9536849993
sumbulansa321@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC GMC HALDWANI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K00-K95||Diseases of the digestive system, (3) ICD-10 Condition: G00-G99||Diseases of the nervous system, (4) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, (5) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (6) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
15ml of 0.4% inj Lignocaine given intravenously |
The study population is divided into 2 groups of 75 patients each . Group A using 15ml of 0.4% inj lignocaine |
| Comparator Agent |
3ml of 2% inj Lignocaine given intravenously |
The study population is divided into 2 groups of 75 patients each. Group B using 3ml of 2% inj Lignocaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients giving informed written consent for participation in study.
2. Patients posted for surgeries under general anesthesia receiving propofol as an induction agent.
3. Age of the patient between 18-65 of either sex.
4. Patients belonging to ASA class I and II. |
|
| ExclusionCriteria |
| Details |
1. Patients with history of any contraindication to propofol or lignocaine.
2. Patients with thrombophlebitis.
3. Patients with history of epilepsy.
4. Patients with psychiatric disorders.
5. Pregnant patients.
6. Patients who had received analgesics prior to anaesthesia. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE 15 ML OF 0.4% LIGNOCAINE VERSUS 3ML OF 2% LIGNOCAINE FOR PREVENTING PAIN ASSOCIATED WITH PROPOFOL INJECTION |
Immediately after propofol injection (within 10 seconds) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To compare Numeric Rating Scale score & Withdrawal Response Score using 15 ml of 0.4 % lignocaine (group A) & 3ml of 2% lignocaine (group B) for preventing pain associated with propofol injection
|
Immediately after propofol injection within ten seconds |
| •To observe side effects if any & compare amongst the group A & group B. |
At baseline immediately post injection 15 minutes post injection & at recovery |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
03/07/2025 |
| 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="6"
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
|
This is a prospective randomized double blind interventional study comparing the effectiveness of two different concentrations and volumes of lignocaine in reducing pain associated with propofol injection. A total of 150 patients scheduled for surgery under general anesthesia will be divided into two groups. Group A will receive 15 ml of 0 point 4 percent lignocaine and Group B will receive 3 ml of 2 percent lignocaine. The Numeric Rating Scale and Withdrawal Response Score will be used to evaluate pain. The study also aims to observe and compare any side effects in both groups. Data will be analyzed statistically with a p value less than 0 point 05 considered significant. The study will be conducted at Dr Susheela Tiwari Government Hospital Haldwani over a period of 18 months |