| CTRI Number |
CTRI/2024/02/063130 [Registered on: 26/02/2024] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study for assessing the risk factors for persistent pain after thoracic surgery |
|
Scientific Title of Study
|
Incidence and risk factors for Chronic post thoracotomy pain and its impact on the quality of life : A prospective observational study in the Indian subcontinent |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anshul Singh |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
department of anesthesiology, AIIMS, NEW DELHI
South
DELHI
110029
India |
| Phone |
99990556767 |
| Fax |
|
| Email |
ansh.dadoc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anshul Singh |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
department of anesthesiology, AIIMS, NEW DELHI
South
DELHI
110029
India |
| Phone |
99990556767 |
| Fax |
|
| Email |
ansh.dadoc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anshul Singh |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
department of anesthesiology, AIIMS, NEW DELHI
South
DELHI
110029
India |
| Phone |
99990556767 |
| Fax |
|
| Email |
ansh.dadoc@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
department of Anaesthesiology,AIIMS, new delhi |
| Address |
5th floor, academic block, ansari nagar |
| 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 |
| anshul singh |
All India Institute of Medical Sciences, New Delhi |
surgical block
ansari nagar
South
DELHI |
99990556767
ansh.dadoc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age>18 years
2. Undergoing Thoracotomy or VATS surgery.
|
|
| ExclusionCriteria |
| Details |
1. Cases of advanced lung malignancy.
2. Patients with a history of stroke or intracranial hypertension.
3. Major uncorrected vision or hearing loss.
4. Patients with pre-existing neuropathic pain limited to thoracic dermatomes like thoracic postherpetic neuralgia.
5. Patients refuse to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the incidence of CPTP following thoracic surgery. |
baseline, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To determine various risk factors influencing the development of CPTP following thoracic surgeries in the Indian population.
2. To determine the nature of CPTP, in terms of neuropathic pain and its effect on quality of life.
3. To compare the sex and age differences in the occurrence of CPTP.
|
3 months and 6 months after surgery |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/03/2024 |
| 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)
Modification(s)
|
Not Applicable |
| 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
|
Thoracic surgeries like thoracotomy as well as video assisted thoracoscopic surgery (VATS), have been associated with one of the highest incidence of chronic post-thoracotomy pain (CPTP) . We aim to design this prospective cohort study to identify various factors influencing the incidence of CPTP, following thoracic surgery in the Indian population and study its impact on the quality of life. We also aim to determine the nature of CPTP, in terms of neuropathic pain and its effect on quality of life |