| CTRI Number |
CTRI/2025/11/096748 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To know the efficacy of drug lignocaine given through venous route to reduce pain after surgery and improve the quality of recovery when compared with another drug fentanyl also given through venous route in patients undergoing robotic and laparoscopic cancer surgeries |
|
Scientific Title of Study
|
Assessment of efficacy of intravenous lignocaine infusion for postoperative analgesia and quality of recovery compared to intravenous fentanyl in patients undergoing robotic,laproscopic oncosurgeries |
| 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 Rajasree O |
| Designation |
Additional professor ,department of anaesthesiology |
| Affiliation |
Regional Cancer Centre |
| Address |
Room no.16
Division of Anaesthesiology Regional Cancer centre
kumarapuram rd,Medical college campus,Thiruvananthapuram, kerala
Thiruvananthapuram
KERALA
695011
India |
| Phone |
8281227024 |
| Fax |
|
| Email |
rajasreesajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Malavika Mohan |
| Designation |
Junior resident, department of anaesthesiology |
| Affiliation |
Regional Cancer Centre |
| Address |
Room no 6
Division of Anaesthesiology Regional Cancer centre
kumarapuram rd ,Medical college campus
Thiruvananthapuram, kerala
India
Thiruvananthapuram
KERALA
695011
India |
| Phone |
7012600672 |
| Fax |
|
| Email |
malavikamohan098@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Malavika Mohan |
| Designation |
Junior resident, department of anaesthesiology |
| Affiliation |
Regional Cancer Centre |
| Address |
Room no 6
Division of Anaesthesiology
Regional Cancer centre
kumarapuram rd,Medical college campus
Thiruvananthapuram, kerala,India
Thiruvananthapuram
KERALA
695011
India |
| Phone |
7012600672 |
| Fax |
|
| Email |
malavikamohan098@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Cancer Centre
Kumarapuram rd,Medical College campus,Thiruvananthapuram,Kerala,India
Pincode 695011 |
|
|
Primary Sponsor
|
| Name |
Dr Rajasree O |
| Address |
Room no16
Division of Anaesthesiology Regional Cancer centre
Kumarapuram rd, Medical college campus, Thiruvananthapuram, kerala, India
Pincode 695011 |
| Type of Sponsor |
Other [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 Malavika Mohan |
Regional Cancer center |
Division of Anaesthesiology kumarapuram rd,Medical college campus,Thiruvananthapuram, kerala ,India
Pincode 695011
Thiruvananthapuram
KERALA |
70012600672
malavikamohan098@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Committee, Regional Cancer Centre, Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl infusion |
Dose-0.5mcg/kg/hr
Duration-24 hrs
Route-Intravenous |
| Intervention |
Lignocaine infusion |
Dose-50mcg/kg/min for 1st hr
25mcg/kg/min for 2nd hr
12mcg/kg/min for next 22hrs
Duration-24 hrs
Route-Intravenous |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) ASA class I and II undergoing robotic and laparoscopic gynaecologic and urologic oncosurgeries under GA
2) Patients who receive intravenous lignocaine infusion as perioperative analgesic |
|
| ExclusionCriteria |
| Details |
1)Known allergy to lignocaine
2)Intraoperative conversion from minimally invasive to laparotomies
3)Patients with hepatic,renal dysfunction, severe cardiac disease and seizure disorders
4)Inability to comprehend NRS or QoR-15
5)Known allergy to paracetamol and NSAIDs
6)Body weight less than 45 kg |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)To assess postoperative pain using nrs
2)To assess quality of recovery using QoR-15 questionnaire
3)To assess incidence of PONV and return of bowel function |
1) for 72hrs postoperatively
2)2nd and 3rd postoperative day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To assess analgesic efficacy of iv lignocaine infusion with another analgesic modality-iv fentanyl
2)Time to discharge from hospital
3) Total opioid consumption |
1) for 72 hours after surgery
3)over 72 hrs postoperatively |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
12/11/2025 |
| 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
|
After intubation intravenous lignocaine will be started via a dedicated pump via dedicated line,at a dose of 50mcg/kg/min for 1st hr followed by 25mcg/kg/min for next hour followed 12mcg/kg/min for next 22hrs Pain will be recorded using NRS at 0,4,8,12,20,24 ,36,72hrs On postoperative days 2 and 3 ,qor-15 questionnaire will be administered to assess quality of recovery Patients will also be assessed for postoperative nausea and vomiting and bowel recovery |