Postoperative Pain Reported to Nurses and Physicians

Comparison of Postoperative Pain Scores Reported by Patients to the Surgical Teams and Nursing Staff

Effective pain control following surgical procedures is a goal for both the patient as well as the medical staff caring for them. There have been numerous studies evaluating differing treatment pathways, but most studies have relied on the Visual Analog Scale (VAS) or Numerical Rating Scale (NRS) to evaluate outcomes. These scales are subjective score given by the patient with no objective data input, therefore making comparisons subject to possible bias. There are no known studies comparing the pain scores provided by the patient to the surgical team compared to the nursing staff caring for the patient. The aim will be to compare these values to see if patients are consistent in their pain rating.

Study Overview

• Status: Completed
• Conditions: Pain; Postoperative Pain; Pain Control
• Intervention / Treatment: Other: Postoperative

Detailed Description

The project will be conducted as a prospective study comparing numerical rating scale pain scores reported by the patients to the surgical team and the nursing staff. All orthopedic inpatients will be eligible for the study. Subjects will not be consented for the study prior to data collection in order to prevent bias. At the conclusion of the patient's involvement in the study they will be informed that their data has been collected and will have the opportunity to opt out of the study, at which time the collected data will be destroyed.

Postoperatively the surgical team will ask the patient to provide a pain score during morning rounds as part of routine care. The pain score will be recorded by a member of the surgical team. Within 60 minutes of their rounds and prior to any pain inducing events (such as physical therapy or repositioning), the surgical team will ask the nurse caring for the patient to enter the room by his/her self and ask the patient the same routine questions including the pain score. The nurse will record the pain score. No member of the surgical team will enter the room while the nurse is present in order to prevent bias. This process will be repeated once a day up to three days for each patient after the patient's operation.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study population will include all postoperative orthopedic patients during the hospitalization.

Description

Inclusion Criteria:

• All inpatient postoperative orthopedic patients will be eligible for the study.

Exclusion Criteria:

• If a patient is unwilling to participate in the study.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Postoperative; The study will evaluate orthopedic postoperative patients during the hospitalization.	Other: Postoperative; No intervention is planned in the study. This study is simply evaluating the consistency with which patients report their pain levels to different members of the medical team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Pain scores will be compared between those reported by the patient to the nurse and physician to evaluate for consistency. The visual analog scale (VAS) ranges from a minimum score of 0 representing "no pain at all" and a maximum score of 10 which represents "worst pain imaginable". The VAS is represented as a 100 mm horizontal line in increments of 10mm. Subjects indicate their pain level on the scale.	3 days

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Benjamin Wilke, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2018
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 18-004244

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No