| CTRI Number |
CTRI/2021/09/036525 [Registered on: 15/09/2021] Trial Registered Prospectively |
| Last Modified On: |
10/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Pain Assessment in patients undergoing neurosurgery |
|
Scientific Title of Study
|
Incidence, Risk factors and Outcomes of Significant Pain in Patients Undergoing Neurosurgery: A Prospective Cohort Study |
| Trial Acronym |
PAIN |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sriganesh Kamath |
| Designation |
Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neuroanesthesia and Neurocritical Care, Neurosciences Faculty Block 3rd Floor, NIMHANS, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
09481445949 |
| Fax |
|
| Email |
drsri23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sriganesh Kamath |
| Designation |
Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neuroanesthesia and Neurocritical Care, Neurosciences Faculty Block 3rd Floor, NIMHANS, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
09481445949 |
| Fax |
|
| Email |
drsri23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sriganesh Kamath |
| Designation |
Professor |
| Affiliation |
NIMHANS |
| Address |
Department of Neuroanesthesia and Neurocritical Care, Neurosciences Faculty Block 3rd Floor, NIMHANS, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
09481445949 |
| Fax |
|
| Email |
drsri23@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIMHANS |
| Address |
NIMHANS, Hosur Road, Bengaluru 560029 |
| Type of Sponsor |
Other [Institute of National Importance, Government of India] |
|
|
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 Sriganesh |
Neurocenter building |
Neurocentre Building, NIMHANS, Bengaluru 560076
Bangalore
KARNATAKA |
09481445949
drsri23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G891||Acute pain, not elsewhere classified, (2) ICD-10 Condition: G892||Chronic pain, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All neurosurgical patients aged 18 and above |
|
| ExclusionCriteria |
| Details |
We will exclude children, patients with GCS < 15, patients not extubated within 2 hours of end of anesthesia and those who not able to respond to our questions on outcomes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and severity of postoperative pain |
Immediate postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Risk factors for postoperative pain |
pre, intra and immediate postoperative period |
| Impact of acute postoperative pain - sleep, hospital stay, satisfaction, time to ambulate |
postoperative period |
| Persistent postoperative pain and impact of activities of daily living, medication needs, sleep, return to work |
3 and 6 months after surgery |
| Nociception level by objective parameter |
intraoperative period |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
15/09/2021 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study, we will be evaluating the incidence of acute and chronic pain after neurosurgery. |