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CTRI Number  CTRI/2024/01/061333 [Registered on: 10/01/2024] Trial Registered Prospectively
Last Modified On: 22/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Assessment of acute pain after surgery using a new tool 
Scientific Title of Study   Development and Validation of a Multidimensional Scoring System for Assessment of Acute Postoperative Pain in Adults  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Charulatha R 
Designation  Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute  
Address  Department of Anaesthesiology, Second floor, Hospital block, Mahatma Gandhi Medical College and Research Institute

Pondicherry
PONDICHERRY
607402
India 
Phone  9894909652  
Fax    
Email  ravindrancharulatha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Charulatha R 
Designation  Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute  
Address  Department of Anaesthesiology, Second floor, Hospital block, Mahatma Gandhi Medical College and Research Institute

Pondicherry
PONDICHERRY
607402
India 
Phone  9894909652  
Fax    
Email  ravindrancharulatha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Charulatha R 
Designation  Professor 
Affiliation  Mahatma Gandhi Medical College and Research Institute  
Address  Department of Anaesthesiology, Second floor, Hospital block, Mahatma Gandhi Medical College and Research Institute

Pondicherry
PONDICHERRY
607402
India 
Phone  9894909652  
Fax    
Email  ravindrancharulatha@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College and Research Institute  
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College and Research Institute  
Address  Pondicherry Cuddalore Road, ECR, Pillayarkuppam, Puducherry, 607402 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Krishna Chakravarthi Shyam   Mahatma Gandhi Medical College and Research Institute   Room number 211, Department of Anaesthesiology, Second floor, Hospital block
Pondicherry
PONDICHERRY 
9840359554

krishnacshyam.24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Medical College and Research Institute Institutional Human Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M848||Other disorders of continuity of bone,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients undergoing surgical fixation of hip and femur fractures
2. Intact cognition to report pain
3. Able to understand the pain assessment tool
 
 
ExclusionCriteria 
Details  Exclusion criteria will be patients shifted to ICU for ventilator support, and patients unable to express the numeric rating scale due to physical disabilities or cognitive deficits.
Patients with preexisting pain in the operative site  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To develop an individualised multidimensional pain assessment tool for acute postoperative pain  24 hours before surgery and postoperative day 1 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="121"
Sample Size from India="121" 
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)   20/01/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ravindrancharulatha@gmail.com].

  6. For how long will this data be available start date provided 01-12-2024 and end date provided 30-11-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Effective management of acute postoperative pain is essential for functional recovery of the patient, for ensuring early mobility, and safe hospital discharge. Assessment of acute postoperative pain is the first step in the management and subsequent choice of analgesic therapy. The commonly used tools for assessment of postoperative pain are unidimensional and assess only the pain intensity. These include the Visual Analog Scale (VAS), Numerical Rating Scale (NRS), Verbal Rating Scale (VRS) and Faces Pain Scale (FPS). 

Despite their extensive use, the reliance on these unidimensional tools as the sole approach to measuring pain is currently insufficient. The tools are used to evaluate pain intensity and do not take functional recovery of the patient into account.1Striving[CR1]  to lower pain intensity scores to zero has resulted in increased opioid analgesic use in the post anesthesia care unit.2,3 Treating pain only by its intensity needs to be abandoned as it has led to the current opioid epidemic in the United States.2,4

The paradigm shift required in pain management is restoration of function by reducing pain scores to the extent that allows the patient to breathe, cough and ambulate; in this scenario, analgesic options will be governed by the intention to maximize functional capacity rather than striving to reduce the patient’s postoperative pain to below a specified numerical value.5

Pain is the cognitive component of nociception and there are various determinants of pain perception apart from the intensity of the nociceptive stimulus. Anxiety, depression, mood stability of the patient, anticipation of pain, cognition of the rating scales are few of the factors which influence perception and reporting of pain scales.6 Hence, patients have difficulties in reporting the complex experience of pain by a single numerical value, or as a mark on a line.7 Assessment of pain only by unidimensional rating scales does not consider the influence of the above-mentioned components. 

Efforts have been made to encourage use of multidimensional tools to assess postoperative pain. The Brief Pain Inventory, the Revised American Pain Society Pain Outcomes Questionnaire and the McGill Pain Questionnaire are the commonly used tools, but these tools involve a detailed assessment, hindering frequent assessment in the postoperative and surgical wards.8 The Functional Activity Score which incorporates functional activity into the scoring system has not been formally validated. 

Hence, we have designed this study to develop a multidimensional scoring system for assessment of acute postoperative pain and to test its reliability in our postoperative patients undergoing fracture hip and femur surgeries. 

Gordon DB. Acute pain assessment tools: let us move beyond simple pain ratings. Current Opinion in Anaesthesiology. 2015 Oct;28(5):565–9. 

2.         Levy N, Sturgess J, Mills P. “Pain as the fifth vital sign” and dependence on the “numerical pain scale” is being abandoned in the US: Why? British Journal of Anaesthesia. 2018 Mar 1;120(3):435–8. 

3.         Baamer RM, Iqbal A, Lobo DN, Knaggs RD, Levy NA, Toh LS. Utility of unidimensional and functional pain assessment tools in adult postoperative patients: a systematic review. British Journal of Anaesthesia. 2022 May;128(5):874–88. 

4.         Mularski RA, White-Chu F, Overbay D, Miller L, Asch SM, Ganzini L. Measuring Pain as the 5th Vital Sign Does Not Improve Quality of Pain Management. J Gen Intern Med. 2006 Jun;21(6):607–12. 

5.         Lapkin S, Fernandez R, Ellwood L, Diwan A. Reliability, validity and generalizability of multidimensional pain assessment tools used in postoperative adult patients: a systematic review protocol. JBI Database of Systematic Reviews and Implementation Reports. 2019 Jul;17(7):1334–40. 

6.         Aceto P, Lai C, Perilli V, Sacco T, Modesti C, Raffaelli M, et al. Factors affecting acute pain perception and analgesics consumption in patients undergoing bariatric surgery. Physiology & Behavior. 2016 Sep;163:1–6. 

7.         Tripathi L, Kumar P. Challenges in pain assessment: Pain intensity scales. Indian J Pain. 2014;28(2):61. 

8.         Martinez JE, Grassi DC, Marques LG. Analysis of the applicability of different pain questionnaires in three hospital settings: outpatient clinic, ward and emergency unit. :6. 


 [CR1]All references must be after the punctuation 

 
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