| CTRI Number |
CTRI/2019/05/019228 [Registered on: 20/05/2019] Trial Registered Prospectively |
| Last Modified On: |
14/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective , repeated measures design |
| Study Design |
Other |
|
Public Title of Study
|
Pain assessment in post operative period in patients unable to complain of pain verbally |
|
Scientific Title of Study
|
Comparison of Critical Care Pain Observation Tool and Non Verbal Pain Scale-Revised for acute pain assessment in non-verbal patients in the early post-operative period |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Archana Sharma |
| Designation |
Junior resident |
| Affiliation |
Lokmanya Tilak municipal medical college and hospital |
| Address |
Department of Anesthesiologist
4th floor, college building,
Lokmanya Tilak municipal medical college and hospital, Sion
Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
|
| Fax |
|
| Email |
greatarchie07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hema gupta |
| Designation |
Pg guide |
| Affiliation |
Lokmanya Tilak municipal medical college and hospital |
| Address |
Department of Anesthesiology
4th floor, college building,
Lokmanya Tilak municipal medical college and hospital, Sion
Mumbai
Mumbai
MAHARASHTRA
400022
India |
| Phone |
9833055659 |
| Fax |
|
| Email |
drhemabg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Archana Sharma |
| Designation |
Junior resident |
| Affiliation |
Lokmanya Tilak municipal medical college and hospital |
| Address |
Department of Anesthesiologist
4th floor, college building,
Lokmanya Tilak municipal medical college and hospital, Sion
Mumbai
MAHARASHTRA
400022
India |
| Phone |
|
| Fax |
|
| Email |
greatarchie07@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lokmanya Tilak municipal medical college and hospital,sion,mumbai |
|
|
Primary Sponsor
|
| Name |
Lokmanya Tilak municipal medical college |
| Address |
Department of Anesthesiologist
4th floor , college building
LTMGH, Sion, Mumbai |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Archana Sharma |
Lokmanya tilak municipal medical college and hospital,soon,mumbai |
post anaesthesia care unit and recovery rooms for various OTs
Mumbai
MAHARASHTRA |
9820454737
greatarchie07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LTMGH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Unable to verbalise or indicate pain by using a traditional verbal scale upon arrival in post Anesthesia care unit |
|
| ExclusionCriteria |
| Details |
Patients with previous diagnosis of chronic cognitive impairment or neurological impairment
Pregnant patients |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of two behavioral pain scales in non verbal sedated patients in early post operative period with RASS score -4 to -1 |
0,15,30,45,60,90,120 minutes upon arrival to post Anesthesia care unit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of pain in non verbal sedated patients in early post operative period through individual pain scales |
0,15,30,45,60,90,120 mins upon arrival to post Anesthesia care unit |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
Final Enrollment numbers achieved (Total)= "94"
Final Enrollment numbers achieved (India)="94" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/06/2019 |
| Date of Study Completion (India) |
31/10/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Patient data including age,gender, primary diagnosis, comorbidities,surgery performed,length of surgery,type of anesthesia administered, analgesia administered, pre-operative vitals will be noted. Upon arrival to post Anesthesia care unit RASS score will be applied first ,if RASS score is -4 to -1 then both the behavioural pain scales will be applied simultaneously to study various parameters like heart rate,blood pressure, oxygen saturation,facial expression,body movements,muscle tension at 0,15,30,45,60,90 and 120 minutes. |