CTRI Number |
CTRI/2022/08/044614 [Registered on: 03/08/2022] Trial Registered Prospectively |
Last Modified On: |
28/01/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of analgesic efficacy of topical lignocaine-prilocaine cream with local infiltration of 2% lignocaine prior to spinal anaesthesia.
|
Scientific Title of Study
|
Comparative evaluation of analgesic efficacy of topical EMLA cream with local infiltration of 2% lignocaine prior to subarachnoid block. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Rajmala Jaiswal |
Designation |
Senior Professor |
Affiliation |
Pandit BD Sharma PGIMS, Rohtak |
Address |
Department of Anaesthesiology and Critical Care, Pandit BD Sharma PGIMS, Rohtak
Rohtak HARYANA 124001 India |
Phone |
9468197449 |
Fax |
|
Email |
para3007@rediff.com |
|
Details of Contact Person Scientific Query
|
Name |
Teyiesito Yano |
Designation |
Post Graduate Student |
Affiliation |
Pandit BD Sharma PGIMS, Rohtak |
Address |
Department of Anaesthesiology and Critical Care, Pandit BD Sharma PGIMS, Rohtak
Rohtak HARYANA 124001 India |
Phone |
9774921342 |
Fax |
|
Email |
teyie.yano@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Teyiesito Yano |
Designation |
Post Graduate Student |
Affiliation |
Pandit BD Sharma PGIMS, Rohtak |
Address |
Department of Anaesthesiology and Critical Care, Pandit BD Sharma PGIMS, Rohtak
Rohtak HARYANA 124001 India |
Phone |
9774921342 |
Fax |
|
Email |
teyie.yano@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesiology and Critical Care,
Pandit BD Sharma Post Graduate Institute of Medical Sciences, Pandit BD Sharma University of Health Sciences, Rohtak, Hayrana - 124001 |
|
Primary Sponsor
|
Name |
Pandit BD Sharma PGIMS Rohtak |
Address |
Department of Anaesthesiology and Critical Care, Pandit BD Sharma PGIMS, Rohtak |
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 |
Teyiesito Yano |
Pandit BD Sharma Post Graduate Institute of Medical Sciences, Rohtak |
Department of Anaesthesiology and Critical Care,
Pandit BD Sharma PGIMS, Rohtak Rohtak HARYANA |
9774921342
teyie.yano@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Biomedical Research Committee, PGIMS/UHS, Rohtak |
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 |
Local infiltration of 2% lignocaine |
This group will include 30 patients in whom skin and deeper structures will be infiltrated with 2ml of 2% lignocaine just prior to lumbar puncture. |
Intervention |
Topical application of Eutectic Mixture of Local Anaesthetics (EMLA) cream |
This group will include 30 patients in whom 2.5 gms of 5% EMLA cream per 10sq.cm will be applied for a minimum of 60 minutes prior to lumbar puncture and covered with an occlusive dressing. After the prescribed time of application of EMLA cream, the occlusive dressing will be removed. The area will be then wiped dry with gauze and observed for signs of any local reactions. Lumbar puncture will be performed after cleaning and draping.
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients of the age 18-60 years, of either sex belonging to ASA grade I and grade II undergoing
1. elective lower abdominal surgery
2. pelvic surgery
3.lower limb surgeries will be selected |
|
ExclusionCriteria |
Details |
Following patients will be excluded
1.Patients allergic EMLA cream or any other local anaesthetics.
2. Pregnant and lactating females.
3. Patients with methaemoglobinaemia
4. Psychiatric disorders
5. Fractures
6. More than 3 attempts at lumbar puncture |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
•Primary objective - To compare the VAS score and 4-point pain score of topical EMLA cream with Lignocaine infiltration during subarachnoid block. |
1.VAS Score will be assessed immediately (within 5 minutes) after lumbar subarachnoid block on the scale of 0-10.
2.the 4-point pain scale will be assessed at the time of spinal needle insertion as:
0 – no response
1 - mild facial grimace
2 - verbal response
3 - movement of the back
|
|
Secondary Outcome
|
Outcome |
TimePoints |
Secondary objective -
1. Haemodynamic response to pain,
2. patients’ satisfaction with analgesia technique,
3. side effects |
1. Haemodynamic response will be measured immediately (within 2 minutes) before and after(within 2minutes) the lumbar subarachnoid block.
2. Patients satisfaction will be assessed immediatey after lumbar subarachnoid block, within 5 minutes before the start of surgery.
3.Patient will be follow up upto 24 hours for any side effects |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
15/08/2022 |
Date of Study Completion (India) |
23/11/2022 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Spinal anaesthesia is a simple, fast, safe and reliable method for surgery of the lower body that provides profound sensory and motor block by a single use of spinal needle to administer local anaesthetics into the subarachnoid space.1It is usually administered in the lumbar region in L3-L4 or L4-L5 space. The main reasons for rejecting neuraxial blocks are fear of needle, backache as well as anticipated immediate pain associated with lumbar puncture.2 Lumbar puncture requires more cooperation of the patients and may at times need multiple punctures which may cause pain and apprehensions in patients. Relieving the lumbar puncture pain not only increases the patient’s satisfaction and comfort, but also let the anaesthetist apply spinal puncture fast and easily.3 Lignocaine 2% solution is routinely used for infiltration of skin and subcutaneous tissues before lumbar puncture to reduce needle prick pain. Infiltration of local anaesthetics requires needle insertion which may itself cause acute pain and discomfort to the patient, may cause masking of anatomical landmarks which are used to identify the lumbar spaces and risks of accidental intravascular administrations.4 EMLA cream provides a non-invasive analgesia and has been effectively used in many studies to reduce needle prick pain.5,6 Eutectic mixture of local anaesthetics (EMLA) is an effective topical anaesthetic mixture containing lignocaine and prilocaine. The mixture is termed eutectic as it has a melting point lower than its individual components. The mixture is liquid at room temperature while the individual components are crystalline substances. EMLA is used for relieving the pain caused during venous and intra-arterial cannula insertions in paediatrics and adult patients, excision of cutaneous lesions, radiofrequency ablation of warts, fine-needle aspiration of thyroid nodules, minor surgical procedures such as during perineal repair after childbirth, for pain control during shockwave lithotripsy, humeral block placement in non-sedated patients, peribulbar injection, mammography, transrectal biopsy of prostate, hysterosalpingography, IUD insertions, dental procedures, epidural injections and lumbar punctures.5,6
The purpose of this study is to find out the efficacy of topical EMLA cream in comparison to the standard infiltration technique in reducing pain of needle insertion during lumbar subarachnoid block and have better patient satisfaction level. |