PainNCT03840356
Postoperative Pain Reported to Nurses and Physicians
An observational study of Pain and Pain Control, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pain, Pain Control, Postoperative Pain
- What is being tested?
- Postoperative
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jun 2018to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Study population: The study population will include all postoperative orthopedic patients during the hospitalization.
Who may be able to join
- All inpatient postoperative orthopedic patients will be eligible for the study.
Who cannot join
- If a patient is unwilling to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Pain Control, Postoperative Pain
- Being tested
- Postoperative
- Medical subject headings
- Pain, Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PostoperativeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative | The study will evaluate orthopedic postoperative patients during the hospitalization. Receives: Other: Postoperative |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start18 Jun 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin K. Wilke, Mayo Clinic
- Investigators
- Benjamin Wilke, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840356
- Sponsor's protocol ID
- 18-004244
- Status last verified
- May 2023
- First submitted
- 11 Feb 2019
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pain Scores Reported by Patients to the Surgical Teams and Nursing Staff
- ClinicalTrials.gov ID
- NCT03840356
- Acronym / sponsor ID
- 18-004244
- Conditions
- Pain, Pain Control, Postoperative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postoperative | – | Other: PostoperativeThe study will evaluate orthopedic postoperative patients during the hospitalization. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population will include all postoperative orthopedic patients during the hospitalization.
Key inclusion criteria (1 listed)
- All inpatient postoperative orthopedic patients will be eligible for the study.
Key exclusion criteria (1 listed)
- If a patient is unwilling to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PostoperativeNo 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. | Other | Postoperative |
Primary outcome
Pain score
Time frame: 3 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Wilke, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Pain Control, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023; AzTrials last refreshed its copy on 1 Nov 2026.