| CTRI Number |
CTRI/2025/01/079593 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/01/2025 |
| 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 dose response to two different doses of intravenous anaesthetic drug lidocaine for postoperative pain relief |
|
Scientific Title of Study
|
Comparison of dose response to two different doses of intravenous lidocaine for postoperative analgesia in patients undergoing elective laparoscopic gynaecological oncology surgery under general anaesthesia : A Prospective randomised controlled study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakshitha K S |
| Designation |
Post graduate resident |
| Affiliation |
Kidwai memorial institute of oncology |
| Address |
Room 105, Department of Anaesthesiology and pain relief, Ground floor, OT complex block, Kidwai memorial institute of oncology, Dr MH Marigowda road, Bangalore.
Bangalore
KARNATAKA
560029
India |
| Phone |
9916149044 |
| Fax |
|
| Email |
rakshithagowdaks5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumitha C S |
| Designation |
Associate Professor |
| Affiliation |
Kidwai memorial institute of oncology |
| Address |
Room 105, Department of Anaesthesiology and pain relief, Ground floor, OT Complex block, Kidwai memorial institute of oncology, Dr MH Marigowda road, Bangalore.
Bangalore
KARNATAKA
560029
India |
| Phone |
9980524241 |
| Fax |
|
| Email |
cssumitha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumitha C S |
| Designation |
Associate Professor |
| Affiliation |
Kidwai memorial institute of oncology |
| Address |
Room 105, Department of Anaesthesiology and pain relief, Ground floor, OT Complex block, Kidwai memorial institute of oncology, Dr MH Marigowda road, Bangalore.
Bangalore
KARNATAKA
560029
India |
| Phone |
9980524241 |
| Fax |
|
| Email |
cssumitha@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and pain relief, Room 105, Ground floor, OT Complex block, Kidwai memorial institute of oncology, Dr MH Marigowda road, Bangalore, Karnataka, India. 560029 |
|
|
Primary Sponsor
|
| Name |
Dr Rakshitha K S |
| Address |
Room 105, Department of Anaesthesiology and pain relief, Ground floor, OT Complex block, Kidwai memorial institute of oncology, Dr MH Marigowda road, Bangalore. 560029 |
| 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 Rakshitha K S |
Kidwai memorial institute of oncology |
Department of Anaesthesiology and pain relief, Room 105, Ground floor, OT Complex block, Kidwai memorial institute of oncology, Dr MH Marigowda road, Bangalore.
Bangalore
KARNATAKA |
9916149044
rakshithagowdaks5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C574||Malignant neoplasm of uterine adnexa, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
intravenous lidocaine infusion |
Before induction of anaesthesia intravenous lidocaine bolus of 1.5mg/kg slowly over 10 mins followed by 1.5mg/kg/hr infusion after induction of anaesthesia for 3 hours. Postoperative VAS score monitoring is done. |
| Intervention |
intravenous lidocaine infusion |
Before induction of anaesthesia intravenous lidocaine bolus of 1.5mg/kg slowly over 10 mins followed by 2mg/kg/hr infusion after induction of anaesthesia for 3 hours. Postoperative VAS score monitoring is done and compared with the other group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1 Patients aged between 18 and 65 years
2 Patients belonging to ASA physical status 1 and 2
3 Patients consenting for study |
|
| ExclusionCriteria |
| Details |
1 Patients with cardiac, respiratory, hepatic or renal diseases.
2 Patients with neurological disorder.
3 Patients with history of alcohol or any drug addiction.
4 Pregnant or breastfeeding females.
5 Known allergic to local anaesthetics. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing Visual Analogue Score(VAS) in postoperative period |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Intraoperative hemodynamic stability
2. Intraoperative requirement of opioids.
3. Assessing time to first analgesic dose and total consumption of rescue analgesic in 24 hours.
4. Side effects of intravenous lidocaine.
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/02/2025 |
| 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="2"
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
|
This is a randomised controlled study comparing the dose response of two different doses of intravenous lidocaine for post operative analgesia. In patients undergoing laparoscopic gynaecological oncologic surgery , patients are allocated into two groups. Patients in group A will receive an intravenous lidocaine bolus of 1.5 mg/kg slowly over 10 mins prior to induction followed by a continuous infusion at the rate of 1.5mg/kg/hour via infusion pump. Patients in group B will receive an intravenous lidocaine bolus of 1.5 mg/kg slowly over 10 mins prior to induction followed by a continuous infusion at the rate of 2 mg/kg/hour via infusion pump. Maintenance of anaesthesia is same in both groups. Primary objective of this study is to assess visual analogue pain score in post operative period and secondary objectives are intraoperative hemodynamic stability, intraoperative opioid requirement , assessing time to first analgesic dose, total consumption of rescue analgesic in 24 hours and side effects of intravenous lidocaine. |