CTRI Number |
CTRI/2020/08/026972 [Registered on: 04/08/2020] Trial Registered Prospectively |
Last Modified On: |
03/11/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Observational |
Type of Study
|
Cohort Study |
Study Design |
Single Arm Study |
Public Title of Study
|
Measurement of pain severity and its relation with the different pain relieving methods in patients undergoing spinal instrumentation surgery |
Scientific Title of Study
|
Assessment of pain intensity and the association of patient satisfaction with analgesic therapy in patients undergoing spinal instrumentation surgery |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Rudrashish Haldar |
Designation |
Assistant Professor |
Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Address |
Dept. of Anaesthesiology, First Floor , A Block,Sanjay Gandhi Post Graduate Institute of Medical Sciences, Rae Bareli Road, Lucknow Rae Bareli Road, Lucknow,Uttar Pradesh Lucknow UTTAR PRADESH 226014 India |
Phone |
9256543256 |
Fax |
|
Email |
rudrashish@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Rudrashish Haldar |
Designation |
Assistant Professor |
Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Address |
Dept. of Anaesthesiology, First Floor , A Block,Sanjay Gandhi Post Graduate Institute of Medical Sciences, Rae Bareli Road, Lucknow Rae Bareli Road, Lucknow,Uttar Pradesh
UTTAR PRADESH 226014 India |
Phone |
9256543256 |
Fax |
|
Email |
rudrashish@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Rudrashish Haldar |
Designation |
Assistant Professor |
Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Address |
Dept. of Anaesthesiology, First Floor , A Block,Sanjay Gandhi Post Graduate Institute of Medical Sciences, Rae Bareli Road, Lucknow Rae Bareli Road, Lucknow,Uttar Pradesh
UTTAR PRADESH 226014 India |
Phone |
9256543256 |
Fax |
|
Email |
rudrashish@yahoo.com |
|
Source of Monetary or Material Support
|
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Rae Bareli Road,Lucknow,Uttar Pradesh,226014 |
|
Primary Sponsor
|
Name |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Address |
Rae Bareli Road, Lucknow,Uttar Pradesh |
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 Rudrashish Haldar |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
Dept. of Anaesthesiology,First Floor, A Block, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Rae Bareli Road, Lucknow Lucknow UTTAR PRADESH |
9256543256
rudrashish@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
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
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
Adult patients (18-65 years)
Patients of either gender
ASA I and II patients
Single or two levels spinal instability requiring fusion
|
|
ExclusionCriteria |
Details |
Patients who are unable to communicate in Hindi
Patients suffering from chronic pain
Patients receiving antipsychotic drugs
Patients consuming analgesics on regular basis
Patients undergoing surgery for malignant disorders and trauma
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To assess the prevalence and the perceived intensity of pain in the immediate post operative period (PACU), on the second and the third post operative day in patients undergoing spinal instrumentation surgery |
6 hours after arrival in Post Anaesthesia Care Unit, 2nd post operative day and 3rd post operative day |
|
Secondary Outcome
|
Outcome |
TimePoints |
1) To determine the correlation between the intensity of pain experienced by the patients and their satisfaction with the pain control measures undertaken by the caregivers |
6 hours after arrival in Post Anaesthesia Care Unit, 2nd post operative day and 3rd post operative day |
|
Target Sample Size
|
Total Sample Size="65" Sample Size from India="65"
Final Enrollment numbers achieved (Total)= "65"
Final Enrollment numbers achieved (India)="65" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
07/08/2020 |
Date of Study Completion (India) |
27/12/2024 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="4" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Spinal instrumentation surgeries are intensely painful procedures. Incongruence exists regarding severity of pain following spinal surgeries and the level of satisfaction of patients with respect to their pain control measures. We attempt to assess the intensity of the pain perceived by patients in the post operative period and dereive whether any correlation exist between the severity of pain perceived and the levels of satisfaction to their pain control measures |