| CTRI Number |
CTRI/2024/12/077832 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
to study the effect of an anaesthetic drug named Lignocaine in patients undergoing brain surgery involving opening of skull for management of pain during and after surgery. |
|
Scientific Title of Study
|
Evaluation of lignocaine infusion for management of pain after supratentorial craniotomy |
| 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 Sandeep Kundra |
| Designation |
Professor Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of anaesthesia Dayanand Medical College and Hospital civil lines ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9815608241 |
| Fax |
|
| Email |
sandeepkundra07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Supreen kaur |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of anaesthesia Dayanand Medical College and Hospital civil lines ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
8360285668 |
| Fax |
|
| Email |
supreenkaur0179@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supreen kaur |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of anaesthesia Dayanand Medical College and Hospital civil lines ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
8360285668 |
| Fax |
|
| Email |
supreenkaur0179@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital, Ludhiana, punjab pin code 141001 |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital |
| Address |
Tagore nagar, Civil lines, Ludhiana, 141001 Punjab India |
| Type of Sponsor |
Private 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 Sandeep Kundra |
Dayanand Medical College and Hospital |
Department of anaesthesia, Neuro OT and Post anaesthesia care unit room
Ludhiana
PUNJAB |
9815608241
sandeepkundra07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethical committe, Dayanand medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G060||Intracranial abscess and granuloma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Evaluation of lignocaine infusion for management of pain after supratentorial craniotomy |
Group A patients undergoing supratentorial craniotomy will be given intravenous Lignocaine bolus at bolus dose of 1.5mg/kg over 5 minutes starting 10 minutes before induction of anaesthesia followed by continuous infusion of 2mg/kg/hr which will be continued till the end of surgery and stopped after extubation |
| Comparator Agent |
Evaluation of lignocaine infusion for management of pain after supratentorial craniotomy |
Group B will be given intravenous normal saline at bolus dose of 1.5mL/kg over 5 minutes starting 10 minutes before induction of anaesthesia followed by continuous infusion of 2mL/kg/hr which will be continued till the end of surgery and stopped after extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult male and femalae patients undergoing supratentorial craniotomy under General Anesthesia, American Society of Anaesthesiologist(ASA) Class 1 and 2, Glasgow Coma Scale of 15. |
|
| ExclusionCriteria |
| Details |
1. Patients having cardiac conduction abnormalities like atrio-ventricular block.
2. Patients with respiratory, hepatic or renal disease.
3. Patients on treatment with calcium channel blockers or beta-blockers.
4. Patients with altered sensorium.
5. Patients with a history of myopathy or substance abuse.
6. Patients who will be kept mechanically ventilated postoperatively.
7. Allergic to study drug.
8. Patient’s refusal. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Analgesic efficacy of IV lignocaine infusion as assessed by post operative pain score measured using Numeric rating scale (NRS). |
Analgesic efficacy of IV lignocaine infusion as assessed by post operative pain score measured using Numeric rating scale (NRS)measured after shifting the patients to post anaesthesia care unit at 0 hour, 1 hour, 2 hour and 3 hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Total opioid consumption in 24 hours from start of surgery
2.To observe for adverse effects, if any during surgery & within 24 hours of surgery |
1.Total opioid consumption till 24 hours after surgery
2.To observe for adverse effects within 24 hours of surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/12/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Pain after craniotomy remains a problem despite the availability of many drugs like opioids, non-steroidal anti-inflammatory drugs (NSAIDS). This is mainly due to concern of adverse effects associated with their use. Lignocaine infusion has shown beneficial effects for management of post operative pain. However, its role in pain following craniotomy is not clear. A prospective, double blind, randomized, placebo controlled study will be conducted on sixty patients undergoing supratentorial craniotomy. Group A patients will be administrated IV bolus of lignocaine in a dose of 1.5mg/kg over 5 minutes starting 10 minutes before induction of anaesthesia followed by a continuous infusion of 2mg/kg/hr which will be continued till the end of surgery and stopped just after tracheal extubation. Whereas, group B will be administrated IV normal saline in a similar dose and duration. Patients will be monitored post operatively for pain in terms of numerical rating scale (NRS) and HR, NIBP, SPO2, RR. We aimed to study the analgesic efficacy and adverse effects of IV lignocaine infusion in patients undergoing supratentorial craniotomy. The primary outcome will be analgesic efficacy of IV lignocaine infusion as assessed by post operative pain score measured using Numeric rating scale (NRS). and secondary outcome will be total opioid consumption in 24 hours and adverse effects, if any. |