| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ravindrancharulatha@gmail.com].
- 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.
- 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 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.
All references must be after the punctuation |