| CTRI Number |
CTRI/2019/01/017001 [Registered on: 09/01/2019] Trial Registered Prospectively |
| Last Modified On: |
08/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the post operative pain levels by comparing three pain assessment scales. |
|
Scientific Title of Study
|
Assessment of postoperative pain-comparing three pain assessment tools. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Narayanan Unnithan H |
| Designation |
Junior Resident |
| Affiliation |
KASTURBA MEDICAL COLLEGE. |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, KASTURBA MEDICAL COLLEGE, MANIPAL.
Udupi
KARNATAKA
576104
India |
| Phone |
8921498091 |
| Fax |
|
| Email |
narayanuh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunath Prabhu |
| Designation |
PROFESSOR |
| Affiliation |
KASTURBA MEDICAL COLLEGE. |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, KASTURBA MEDICAL COLLEGE, MANIPAL.
Udupi
KARNATAKA
576104
India |
| Phone |
9480346128 |
| Fax |
|
| Email |
manjaparkala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmi Shenoy |
| Designation |
Assistant Professor |
| Affiliation |
KASTURBA MEDICAL COLLEGE. |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, KASTURBA MEDICAL COLLEGE, MANIPAL.
Udupi
KARNATAKA
576104
India |
| Phone |
8073822017 |
| Fax |
|
| Email |
drlaxmishenoy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education,Kasturba Medical College and Hospital,Manipal,Udupi |
|
|
Primary Sponsor
|
| Name |
PG Thesis fund KMC Manipal |
| Address |
Kasturba Medical College and Hospital,Manipal,Udupi District,Karnataka. |
| 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 Narayanan Unnithan H |
Kasturba Medical College and Hospital |
Department of Anaesthesiology,OT Complex,1st floor,
Kasturba Medical College,Manipal.
Udupi
KARNATAKA |
8921498091
narayanuh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital 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 |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients undergoing elective open surgical procedures. |
|
| ExclusionCriteria |
| Details |
Neurosurgical patients.
Patients not able to communicate.
Patients not able to understand pain assessment tools. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Scale reliability was evaluated using intraclass correlation coefficients (ICCs). Scale validity was assessed by correlations between scales, analysis of variance with repeated measures, and the sensitivity of the scales to interventions. |
Once patient rates his pain then he will be asked whether he need analgesic medication. Analgesic medicine will be given as per the postoperative order by the concerned Anaesthesia team. Following 10 minutes pain score is reassessed. Further analgesic dose will be administered as per patients demand till he says no pain or pain is tolerable or patient becomes drowsy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Chi-square tests were used to investigate if error rate and preference rate were related to gender, age, and eucational level. |
Once patient rates his pain then he will be asked whether he need analgesic medication. Analgesic medicine will be given as per the postoperative order by the concerned Anaesthesia team. Following 10 minutes pain score is reassessed. Further analgesic dose will be administered as per patients demand till he says no pain or pain is tolerable or patient becomes drowsy. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/01/2019 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To evaluate the post operative pain levels by comparing three different pain scales.Comparing the validity of visual analogue scale,numerical rating scale and ordinal scales as post operative pain assessment tools.scale validity assessed by correlations between the scales,analysis of variance with repeated measures and sensitivity of scales to interventions.Once patient rates pain then he will be asked whether he need analgesic medication.Analgesic medicine will be given as per the post operative order by the concerned Anaesthesia team.Following 10 minutes pain score is reassessed .Further analgesic dose will be administered as per patient demand till he says no pain or pain is tolerable or patient becomes drowsy. |