PASS Pain After Surgery
NCT Number: NCT06506110
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Analgesia
Interventions: OTHER: Retrieving of retrospective data from Epic
Sponsor: University Health Network, Toronto
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 7000
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-11
Completion Date: 2024-12-31
Locations: Toronto Western Hospital, Toronto, Ontario, M5T 2S8, Canada

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. 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.

Primary Outcome Measures: 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., First 48 hours after surgery
Secondary Outcome Measures: 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., First 48 hours after surgery|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., First 48 hours after surgery|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., First 48 hours after surgery|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, First 48 hours after surgery