| CTRI Number |
CTRI/2025/08/092924 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the Impact of Interventional Techniques on Cancer Pain. |
|
Scientific Title of Study
|
Evaluating the Impact of Interventional Techniques on Cancer Pain: Insights from Retrospective and Prospective Observations |
| 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 Sheetal Gaikwad |
| Designation |
Professor, Tata Memorial Hospital |
| Affiliation |
Tata Memorial Hospital |
| Address |
Dept of Anesthesiology, Critical Care and Pain, Tata Memorial Hospital, Dr Ernst Borges Marg, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9422604296 |
| Fax |
|
| Email |
drsheetalvgaikwad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sheetal Gaikwad |
| Designation |
Professor, Tata Memorial Hospital |
| Affiliation |
Tata Memorial Hospital |
| Address |
Dept of Anesthesiology, Critical Care and Pain, Tata Memorial Hospital, Dr Ernst Borges Marg, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9422604296 |
| Fax |
|
| Email |
drsheetalvgaikwad@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Beria |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Hospital |
| Address |
Dept of Anesthesiology, Critical Care and Pain, Tata Memorial Hospital, Dr Ernst Borges Marg, Parel
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9819814188 |
| Fax |
|
| Email |
31.07rahulberia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, Parel, Mumbai 400012 |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Homi Babha Building, Dr Ernest Borges Rd, Parel East, Parel, Mumbai, Maharashtra 400012 |
| 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 Sheetal Gaikwad |
Tata Memorial Hospital |
Department of Anaesthesiology, Critical Care and Pain management, second floor, main building,Parel,
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA |
9422604296
drsheetalvgaikwad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee 1 |
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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) All consenting patients with age more than 18 years, who will undergo interventional pain management
2) All patients who had undergone interventional pain management |
|
| ExclusionCriteria |
| Details |
1) Refusal to consent
2) Special population like pregnant females |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary objective : To compare pre-procedure worst pain scores with 1 week post procedure
scores |
Pre procedure and 1 week post procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary objective :
1) Impact of pain on daily function at 1week as recorded by using BPI
2) Impact of pain on daily function at 1 month by using BPI
3) Compare pre procedure average pain scores with immediate post procedure average pain scores
4) Compare pre procedure average pain scores with average pain scores at 1 week post procedure
5) Compare worst pain scores preprocedure with worst pain scores at 1 month post procedure
6) Percentage of decrease in opioid doses in morphine equivalents at 1 week and 1 month if any
|
pre procedure and 1 week and 1 month post procedure |
|
|
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)
|
23/08/2025 |
| 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
|
Pain is the most common symptom experienced by cancer patients. Poorly controlled pain has been shown to diminish quality of life, reducing functional status and negatively impacting mental well being. Interventional pain procedures provide an adjunct to traditional medical management for cancer and non cancer patients with intractable or refractory pain. These procedures are beneficial when side effects of medications limit optimal pain control. These interventions range from simple muscle and nerve blocks to complex treatments like implantable devices and central nervous system ablations We hypothesise that interventional pain procedures could significantly improve pain relief and thereby pain scores and possibly improve the daily function of cancer patients. Brief Pain inventory will be filled pre interventional procedure and at 1week and 1 month post procedure The following parameters would be recorded Opioid dosage converted into Morphine equivalents Numeric rating pain scores Brief Pain Inventory pain scores Side effects of opioids
|