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AnalgesiaNCT06506110

PASS Pain After Surgery

An observational study of Analgesia, run by University Health Network, Toronto at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The numeric rating scale (NRS) is one way to assess how much pain a patient is feeling after surgery, ranging from 0 (no pain) to 10 (the worst pain imaginable). The score getting lower can thus indicate pain relief. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Analgesia
What is being tested?
Retrieving of retrospective data from Epic
Type of treatment
Injection or infusion
How many people
7,000 participants
Where
1 siteCanada
Study dates
11 Jul 2024to 28 Feb 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Adult patients who received intravenous patient-controlled analgesia (PCA) following surgery at the University Health Network (UHN) during the study period.

Who may be able to join

  • Had surgery at the UHN during the study period
  • Received intravenous PCA within the first 48 hours after surgery
  • Have at least 1 NRS rating and 1 satisfaction rating in the first 48 hours after surgery

Who cannot join

  • Use of epidural analgesia in the first 48 hours after surgery

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

Other trials in Canada

About this study

Official title: Determining the Patient Acceptable Symptom State (PASS) for Acute Pain After Surgery - A Retrospective Study

The numeric rating scale (NRS) is one way to assess how much pain a patient is feeling after surgery, ranging from 0 (no pain) to 10 (the worst pain imaginable). The score getting lower can thus indicate pain relief. However, a small change in the score does not mean that the patient is actually satisfied with their pain relief treatment. The PASS (patient acceptable symptom state) is the score threshold beyond which a patient considers their treatment satisfactory.

The purpose of this observational study is to find out the PASS for the NRS in the first 48 hours after surgery. This will help guide future research on pain medicine, so that new techniques can deliver adequate patient satisfaction.

Read the detailed description

As healthcare delivery and research studies become more patient-centered, patient-reported outcome measures (PROMs) - instruments completed by a patient to capture their health status (e.g., pain, quality of life, function) - are increasingly used. However little attention has been paid to PROMs in the acute phase of postoperative recovery. Given that many patients experience moderate to severe pain in the first day following surgery (e.g., 50% for joint replacement surgery), and that acute postsurgical pain is associated with long-term outcomes, a focus on patient-reported acute pain following surgery is needed.

Both acute and chronic postoperative pain are commonly assessed using the 100 mm visual analogue scale (VAS, 0 mm = no pain to 100 mm = worst possible pain) or numeric rating scale (NRS, 0 = no pain to 10 = worst possible pain). While a reduction in the VAS or NRS pain score indicates some degree of pain relief, neither the raw numerical score nor the statistical significance of a score's change indicates whether the change is perceived by patients to be meaningful. Instead, the Patient Acceptable Symptom State (PASS), which represents the threshold beyond which patients consider themselves well or satisfied with a treatment, can be used to determine the proportion of patients that responded to treatment (i.e., the proportion of patients that achieved the PASS) and to calculate the number needed to treat. Little to no data has been found concerning the PASS for acute postsurgical pain. There has been somewhat more work quantifying the Minimum Clinically Important Difference (MCID; the smallest change that is important to patients), which is a related concept to the PASS that also determines the clinical significance of a change in pain score. The MCID varies widely across chronic pain disorders (from 8 mm for scleroderma to 82 mm for trigeminal neuralgia) and across non-surgical acute pain conditions (from 8 mm for patients presenting to the emergency department to 40 mm for rheumatic conditions). Therefore, the PASS for acute pain following surgeries is expected to vary based on the type of surgery, but this has not been determined. Similarly, there is no known study of the consistency in PASS throughout the postoperative period or across the patient and surgical factors that are known to be important for MCID (e.g., preoperative pain, pain expectations), or the opioid dose (measured in morphine milligram equivalents) needed to achieve the PASS.

The primary objective of this study is to determine the PASS for the NRS pain score in the first 48 hours after surgery in patients who received intravenous patient-controlled analgesia (PCA). The study includes patients who have undergone surgery at UHN between June 4, 2022, and December 31, 2023 (the study period). Patients will be identified using the Epic data management software. All required data for this study will be obtained from the Epic electronic medical record at UHN. For patients who are on intravenous PCA, the patient's pain score at rest and with activity is taken using the NRS multiple times per day and recorded in Epic. Each time the NRS is taken, the patient's satisfaction (yes/no) is also recorded along with the cumulative PCA opioid dose.

This study will include a descriptive analysis of the data collected. The descriptive analysis will be used to summarize the characteristics of the study population and to identify patterns and trends in the data. Measures of central tendency (e.g., mean, median, mode) and measures of variability (e.g., standard deviation, range) will be calculated for continuous variables. Frequency distributions and proportions will be used to describe categorical variables. Missing data will not be imputed but will be reported for every variable. Graphs and charts will be used to visualize the data. Histograms, bar charts, and pie charts will be used to describe the distribution of continuous and categorical variables.

Conditions
Analgesia
Being tested
Retrieving of retrospective data from Epic
Keywords
PASS, MCID, NRS pain score, Acute pain
Medical subject headings
Agnosia, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Retrieving of retrospective data from EpicOther

    Retrospective data from Epic will be extracted to determine the Patient Acceptable Symptom State (PASS) for the numeric rating scale (NRS) pain score in the first 48 hours after surgery in patients who received intravenous Patient Controlled Analgesia.

Study groups in NCT06506110
Study groupRoleWhat they receive
Patients who received intravenous PCA following surgery at the UHNPatients who received intravenous PCA following surgery at the UHN from the period of June 4, 2022 to December 31, 2023.
Receives: Other: Retrieving of retrospective data from Epic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PASS for the NRS

    The PASS for the NRS pain score in the first 48 hours after surgery in patients who received intravenous PCA.

    To determine PASS, patients responding "yes" to the satisfaction question in Epic are considered to have an acceptable pain state at that time. Each patient can contribute multiple NRS scores. PASS will be calculated as:

    • the 75th centile of the NRS taken at the time of the "yes" satisfaction response
    • the highest NRS pain score at which each patient considers themselves satisfied. The NRS PASS will be the mean of these scores.
    • the NRS cut-off that optimizes the sensitivity and specificity between satisfied and unsatisfied responses using receiver-operating characteristic (ROC) curves

    The method that gives the PASS with the best sensitivity and specificity will be determined. These methods will be used to calculate the PASS separately for pain at rest and with movement. This will be done for the entire 48-hour period, separately for each surgery.

    Measured: First 48 hours after surgery

Secondary outcomes (4)
  1. Consistency of PASS for the NRS

    The degree to which the PASS for the NRS pain score changes across the PACU, and the first 0-6, 6-12, 12-24, 24-36, and 36-48 hours after surgery, separately for each surgery.

    Measured: First 48 hours after surgery

  2. Patient and procedure factors associated with PASS for the NRS

    To determine the patient and procedure factors associated with the PASS, a subgroup analysis will be conducted to explore differences in the PASS (with a 95% confidence interval) for different patient groups (e.g., preoperative use of opioids, sex, age, comorbidities). Descriptive statistics and graphical representations will be used for each subgroup. Factors associated with the PASS will be explored using multivariable models (which may include logistic regression, Poisson regression, negative binomial regression, according to the nature of the data) adjusting for patient and procedure characteristics. Tests will be 2-sided and a p-value less than 0.05 will be considered statistically significant.

    Measured: First 48 hours after surgery

  3. Opioid dose needed to achieve PASS for the NRS

    To determine the opioid dose (in morphine milligram equivalents) that is required to achieve the PASS for the NRS, the median opioid dose in the 4 hours before the NRS was taken will be calculated for those patients that achieved the PASS (with 95% confidence interval). It will be explored whether this varies by patient and procedure factors.

    Measured: First 48 hours after surgery

  4. MCID for the NRS

    The MCID for the NRS pain score in the first 48 hours after surgery in patients who received intravenous PCA.

    Distribution-based methods will be used to determine the MCID for the NRS. The MCID will be defined as:

    • 0.3 standard deviations of the NRS pain scores taken in the first 48 hours after surgery
    • The Standard Error of the Measurement (SEM) of NRS pain scores taken in the first 48 hours after surgery

    Measured: First 48 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2024
  2. Study start11 Jul 2024
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion28 Feb 2025 (estimated)

Resources

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
Retrospective
Enrolment
7,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06506110
Sponsor's protocol ID
24-5290
Other IDs
CAPCR# 24-5290
Status last verified
Dec 2024
First submitted
11 Jul 2024
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Analgesia, run by University Health Network, Toronto at 1 site in Canada.

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 3 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: under way, not looking for participants, as of the sponsor's last update on 4 Dec 2024. 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 Canada. 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?

This study is still under way. Results are not available in the source record yet.

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?

PASS for the NRS (time frame: First 48 hours after surgery). 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 4 Dec 2024.

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