| CTRI Number |
CTRI/2023/08/055969 [Registered on: 01/08/2023] Trial Registered Prospectively |
| Last Modified On: |
30/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effects of intravenous Lignocaine and Ketamine on postoperative pain after Ear, Nose and Throat surgeries. |
|
Scientific Title of Study
|
Comparison between the effects of intravenous Lignocaine & Ketamine on postoperative pain after Ear, Nose and Throat surgeries. |
| 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 Megha M Rao |
| Designation |
Post graduate MD Anaesthesiology |
| Affiliation |
Karnataka institute of medical sciences,Hubbali |
| Address |
Department of Anaesthesiology, KIMS, Hubbali
Dharwad
KARNATAKA
580021
India |
| Phone |
9535628600 |
| Fax |
|
| Email |
Meghamrao24396@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwini H R |
| Designation |
Associate Professor, Department of Anaesthesiology |
| Affiliation |
Karnataka institute of medical sciences, Hubbali |
| Address |
Department of Anaesthesiology, KIMS, Hubbali
Dharwad
KARNATAKA
580021
India |
| Phone |
9480553670 |
| Fax |
|
| Email |
ashvenki.hubli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ahswini H R |
| Designation |
Associate Professor, Department of Anaesthesiology |
| Affiliation |
Karnataka institute of medical sciences, hubbali |
| Address |
Department of Anaesthesiology, KIMS, Hubbali
Dharwad
KARNATAKA
580021
India |
| Phone |
9480553670 |
| Fax |
|
| Email |
ashvenki.hubli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka institute of medical sciences, Hubbali |
|
|
Primary Sponsor
|
| Name |
Dr Megha M Rao |
| Address |
Karnataka institute of medical sciences, Hubbali |
| 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 Ashwini H R |
Karnataka institute of medical sciences |
Department of Anesthesiiology, Karnataka institute of medical sciences, Vidhyanagar, Hubbali
Dharwad
KARNATAKA |
9480553670
ashvenki.hubli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Karnataka Institute of Medical Sciences, Hubballi Ethics Committee |
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 |
Intravenous Ketamine 0.3mg/kg |
Intravenous Ketamine 0.3mg/kg bolus after induction followed by 0.15mg/kg/hr continuous infusion till completion of surgery |
| Intervention |
Intravenous Lignocaine 1.5mg/kg |
Intravenous Lignocaine 1.5mg/kg bolus after induction followed by 1.5mg/kg/hr continuous infusion till completion of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA class I and II |
|
| ExclusionCriteria |
| Details |
Patients requiring postoperative mechanical ventilation or regional analgesia
Patients on perioperative gabapentin, magnesium
Pregnant or breastfeeding mothers
BMI more or equal to 35kh/sq meter
Allergy or contraindications to study medications.
Patients with cardiac, renal or hepatic disease.
Patients with seizure or other neurological disorder.
Patients with chronic preoperative opioid use or substance abuse and history of chronic pain. |
|
|
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 |
| Pain assessed post operatively |
Assessment of pain immediately post op,
1hour,
6hour,
12hour and
24hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| First & total rescue analgesia (paracetamol) consumed |
24 hours post-operatively. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 |
|
Date of First Enrollment (India)
|
20/08/2023 |
| 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
|
Adequate post operative pain management is an essential part of perioperative care because postoperative pain causes patient discomfort and may reduce patient satisfaction. More importantly, it can increase the risk for pulmonary and cardiovascular complications and may even lead to the onset of chronic pain. Rates of absence from work for more than 2 weeks following routine ENT surgery and rates of readmission or overstay after nasal surgery are more than 10% suggesting that this patient group cannot be neglected. Pain levels experienced by patients who have undergone an ENT procedure are probably underestimated. Recently there is a growing interest in the use of different analgesic adjuncts like intravenous infusion of local anesthetics (eg, Lignocaine) and NMDA receptor antagonist (eg, Ketamine). Lignocaine is a local anesthetic which mainly acts as a voltage-gated sodium channel blocker and has analgesic, anti-hyperalgesic and anti-inflammatory properties. Ketamine has good analgesic properties and prevents the development of central sensitization, hyperalgesia and opioid resistance when administered in sub-anesthetic doses. Recent studies in this field have shown mixed results and there is paucity of research trials on post-operative pain in ENT surgeries hence, this study was planned. |