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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04124289
Other study ID # 1906-25
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 29, 2019
Est. completion date July 2, 2020

Study information

Verified date January 2023
Source The Guthrie Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This will be an observational cohort study to evaluate pain measurement after surgery using a new functional pain scale.


Description:

Patients admitted for orthopedic surgery may take part in this research. Participants will be assessed using three different pain scales: numeric rating scale (NRS), FACES pain scale and a new functional pain scale (FPS).


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date July 2, 2020
Est. primary completion date January 21, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Completed orthopedic (hip or knee) surgery - English as primary language and able to read - Low risk as assessed by Opioid Risk Assessment Tool (ORAT) - No history of opioid abuse - Patients with a diagnosis of chronic pain other than the scheduled hip or knee meeting the above criteria may be included. Exclusion Criteria: - Previous diagnosis of cognitive impairment

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Pain measurement using 3 scales
Patients will assess their pain after surgery using three different pain scales.

Locations

Country Name City State
United States Robert Packer Hospital Sayre Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
The Guthrie Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in pain score using functional pain scale questionnaire Change in pain measurement using new functional pain scale from baseline postoperatively until discharge. The functional pain scale is a scale of 10 descriptive words related to pain and ability to function, ranging from minimal to immobilizing Through study completion, an average of 4 days.
Primary Change in pain score using FACES pain scale Change in pain measurement using FACES pain scale from baseline postoperatively until discharge. The scale includes pictures of facial expressions with correlating numerical scale of 0-10, 0 being no hurt and 10 being the worst hurt. Through study completion, an average of 4 days.
Primary Change in pain score using numeric 0-10 rating scale Change in pain measurement using standard numeric rating scale from baseline postoperatively until discharge. The numeric rating scale is 0-10 where 0 is no pain, 5 is moderate pain and 10 is the worst pain. Through study completion, an average of 4 days.
Primary Change in functionality Change in patient's ability to complete daily functions from baseline postoperatively until discharge. Physical therapy and occupational therapy reports will be reviewed to see if pain appears to interfere with the ability to participate in rehabilitation therapy. Through study completion, an average of 4 days.
Secondary Patient preference for ease of use of the three pain scales (functional, FACES or numerical) Questionnaire: Patient will be asked to answer one question to choose which of the three pain scales they prefer for reporting their level of pain. On a scale of 1 to 3 with 1 being the best for reporting pain, the patient will choose which pain scale they would rank a 1. Through study completion, an average of 4 days.
Secondary Provider preference for ease of use of the three pain scales (functional, FACES or numerical) Questionnaire: Provider will be asked to answer one question regarding which of the three pain scales they found easiest to complete. On a scale of 1 to 3 with 1 being the best for ease of use, the provider will choose which pain scale they would rank a 1. Through study completion, an average of 4 days.
Secondary Opioid administration Dose of opioid administered postoperatively during the hospital stay Through study completion, an average of 4 days
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