| CTRI Number |
CTRI/2023/01/048741 [Registered on: 04/01/2023] Trial Registered Prospectively |
| Last Modified On: |
19/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of lignocaine to decrease pain in patients undergoing RFA liver |
|
Scientific Title of Study
|
To analyse the effect of topicalization of Glissonian capsule with 2% Lignocaine on anaesthetic drug doses for Monitored anaesthesia care in Percutaneous radiofrequency ablation of Liver. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SEEMA SHUKLA |
| Designation |
Attending consultant |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Department of Anaesthesia;Operating room number-5;Third Floor; Major Operation Theatre Division; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini
North West
DELHI
110085
India |
| Phone |
7579217527 |
| Fax |
|
| Email |
drseema13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitesh goel |
| Designation |
consultant |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Address Department of Anaesthesia; Room Number 7; Third Floor; Major Operation Theatre Division; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini
North West
DELHI
110085
India |
| Phone |
9717773292 |
| Fax |
|
| Email |
drniteshgoel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitesh goel |
| Designation |
consultant |
| Affiliation |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Address Department of Anaesthesia; Room Number 7; Third Floor; Major Operation Theatre Division; Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini
North West
DELHI
110085
India |
| Phone |
9717773292 |
| Fax |
|
| Email |
drniteshgoel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi Cancer Institute
Secto 5, Rohini, New Delhi |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Cancer Institute and Research Centre |
| Address |
Department of Anaesthesia;Third Floor; Major Operation Theatre Division; Consultants Room;Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini |
| Type of Sponsor |
Research institution and hospital |
|
|
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 seema shukla |
Rajiv Gandhi Cancer Institute and Research Centre |
Operation Room no:5;Department of Anaesthesia;Operation Theatre Division;Third Floor ;Old Building;Sector-5;Rohini;
North West
DELHI |
7579217527
drseema13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Rajiv Gandhi Cancer Institute and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C228||Malignant neoplasm of liver, primary, unspecified as to type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2% lignocaine |
upto 5ml/kg of 2% lignocaine will be infiltrated at liver capsule over the subcapsular lesion.
Duration of procedure 20 min |
| Comparator Agent |
No intervention at liver capsule |
no infiltration
Duration of procedure 20 min |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA Grade(I-III)
2.All patients with Subcapsular Liver lesion posted for RFA/microwave ablation
|
|
| ExclusionCriteria |
| Details |
1.Patients with history of M.I, Arrythmia or any other cardiac morbidity.
2.Difficult airway
3.Deranged liver function test and coagulation profile
4.Chronic alcoholic
5.History of any cognitive or psychiatric illness
6.Patients on medication for chronic pain
7.Allergy to Lignocaine
8.Patient on ventilator, poor GCS
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To achieve a visual analogue pain score of 3 during the procedure. |
0 min Baseline preprocedure
2 min after start of procedure
6 min after start of procedure
8 min after start of procedure
10 min after start of procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare visual analogue score in post procedure period |
0 hour immediate post procedure
6 hour post procedure
10 hour post procedure
14 hour post procedure |
| Heart Rate |
0 min Baseline preprocedure
2 min after start of procedure
6 min after start of procedure
8 min after start of procedure
10 min after start of
procedure
0 hour immediate post
procedure
6 hour post procedure
10 hour post procedure
14 hour post procedure
|
| Mean arterial pressure |
0 min Baseline preprocedure
2 min after start of procedure
6 min after start of procedure
8 min after start of procedure
10 min after start of
procedure
0 hour immediate post
procedure
6 hour post procedure
10 hour post procedure
14 hour post procedure |
| Respiratory rate |
0 min Baseline preprocedure
2 min after start of procedure
6 min after start of procedure
8 min after start of procedure
10 min after start of
procedure
0 hour immediate post
procedure
6 hour post procedure
10 hour post procedure
14 hour post procedure |
| Arterial oxygen saturation |
0 min Baseline preprocedure
2 min after start of procedure
6 min after start of procedure
8 min after start of procedure
10 min after start of
procedure
0 hour immediate post
procedure
6 hour post procedure
10 hour post procedure
14 hour post procedure |
| To compare the Observer assessment of alertness score |
0 min Baseline preprocedure
2 min after start of procedure
6 min after start of procedure
8 min after start of procedure
10 min after start of
procedure
0 hour immediate post
procedure
6 hour post procedure
10 hour post procedure
14 hour post procedure |
| To compare the patient, anaesthetist and Interventional radiologist satisfaction score. |
Post procedure |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
16/01/2023 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Percutaneous radiofrequency ablation (PRFA) of solid tumors is a minimally invasive procedure to treat primary and/or metastatic solid tumors via thermal tissue destruction as a result of targeted thermal energy deposition and coagulative necrosis. Glisson’s capsule, the fibrous covering of the liver, is innervated by branches of the lower intercostal nerves which carries sensory pathway for pain. The RFA of a subcapsular tumor causes generation of heat and gases due to burning of tumor tissue. This in turn stimulates the sensory nerve endings at the Glisson’s capsule causing severe pain. This also make the ablation difficult as patient moves due to pain and may thus displace the ablation needle. Most common method of sedation and analgesia for such procedures include: intravenous opioids, dexmedetomidine infusion, inj. ketamine and propofol. Mixture of these drugs in different doses helps the radiologist to complete the procedure with calm patient when the lesion is in liver parenchyma. For subcapsular region, the situation is different. To combat severe pain due to liver capsule irritation, high doses of these drugs are given which in turn also causes respiratory depression and obstructed airway further complicating the situation. Most commonly used drugs for such scenario are propofol and ketamine. In view of these issues we propose a hypothesis that topicalization of Glissonian capsule with 2% lignocaine will provide adequate analgesia and reduces the dosage of anaesthetic drug. |