| CTRI Number |
CTRI/2023/10/058966 [Registered on: 20/10/2023] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs, Lignocaine and Ketamine intravenous infusion in management of difficult cancer pain |
|
Scientific Title of Study
|
Comparison of Ketamine Vs Lignocaine intravenous infusion in refractory cancer pain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pulluri Sai Sowmya |
| Designation |
Dnb resident |
| Affiliation |
Baswatarakam Indo American cancer Hospital and research Institute |
| Address |
Department of Pain and Palliative,block 1- Room -120, Baswatarakam Indo American cancer Hospital and research Institute, Banjara hills
Hyderabad
TELANGANA
500034
India |
| Phone |
9515376746 |
| Fax |
|
| Email |
pullurisai22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Praveen Kumar Kodisharapu |
| Designation |
Sr Consultant Onco Anaesthesia,Pain and Palliative medicine |
| Affiliation |
Baswatarakam Indo American cancer Hospital and research Institute |
| Address |
Department of Pain and Palliative,block 1- Room -120 Baswatarakam Indo American cancer Hospital and research Institute, Banjara hills
Hyderabad
TELANGANA
500034
India |
| Phone |
9959893915 |
| Fax |
|
| Email |
drprawin78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pulluri Sai Sowmya |
| Designation |
Dnb resident |
| Affiliation |
Baswatarakam Indo American cancer Hospital and research Institute |
| Address |
Department of Pain and Palliative,block 1- Room -120 Baswatarakam Indo American cancer Hospital and research Institute, Banjara hills
Hyderabad
TELANGANA
500034
India |
| Phone |
500034 |
| Fax |
|
| Email |
pullurisai22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pain and Palliative,block 1- Room -120 Basavatarakam Indo American cancer Hospital and Research Institute Hyderabad |
|
|
Primary Sponsor
|
| Name |
Basavatarakam Indo American Cancer Hospital and Research Institute, Hyderabad |
| Address |
BIACHRI, Road no 10, Banjara Hills,Hyderabad |
| 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 |
| Sai Sowmya Pulluri |
Basavatarakam Indo American cancer Hospital and Research Institute Hyderabad |
Department of Pain and Palliative,block 1- Room -120 BIACHRI, Road no. 10, banjara hills, Hyderabad 500034
Hyderabad
TELANGANA |
9515376746
pullurisai22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committe-BIACHRI |
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 |
Ketamine |
Inj Ketamine 0.3mg/kg/hr over 6hrs 2 infusions with 12hrs apart FOLLOW UP for 6weeks |
| Intervention |
Lignocaine |
Inj Lignocaine 2mg/kg/hr over 6hrs 2 infusions with 12hrs apart-FOLLOW UP for 6weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Refractory cancer pain with NRS >6-7/10 despite optimal opioid drugs (OME
>300 mg / day)
Patients with refractory neuropathic/mixed pain Patients with life span >8weeks
|
|
| ExclusionCriteria |
| Details |
H/O psychosis
Any liver, kidney and heart abnormalities Patients with altered cognitive function
H/O drugs hypersensitivity
Patients not giving consent
|
|
|
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 |
| Comparison of Ketamine Vs Lignocaine intravenous infusion in refractory cancer pain in reducing severity of pain atleast by 50% |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Comparison of side effect profile & tolerability of both drugs
2.Comparison of time interval in both drugs till next relapse of acute pain crisis |
1 year |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 4 |
|
Date of First Enrollment (India)
|
30/10/2023 |
| 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)
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
|
This study is a randomized, double blind, parallel group, comparing the lignocaine 2mg/kg/hr IV infusion and Ketamine 0.3mg/kg/hr IV infusion over 6hrs -2 infusions with 12hrs apart , efficacy in reducing the refractory cancer pain in 66 patients that will be conducted in one center in India. The primary outcome will be comparison of both the drugs in reducing severity of refractory cancer pain at least by 50% and secondary outcome will be comparison of side effect profile and tolerability of both drugs and time interval of next relapse of acute pain crisis.
|