PASS Pain After Surgery

NCT06506110 | Active Not Recruiting

• 2 other identifiers: 24-5290CAPCR# 24-5290
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Analgesia

Keywords

PASS; MCID; NRS pain score; Acute pain

Outcome Measures

Primary Outcomes (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.

  First 48 hours after surgery

Secondary Outcomes (4)

• Consistency of PASS for the NRS

  First 48 hours after surgery

• Patient and procedure factors associated with PASS for the NRS

  First 48 hours after surgery

• Opioid dose needed to achieve PASS for the NRS

  First 48 hours after surgery

• MCID for the NRS

  First 48 hours after surgery

Study Arms (1)

Patients who received intravenous PCA following surgery at the UHN

Patients who received intravenous PCA following surgery at the UHN from the period of June 4, 2022 to December 31, 2023.

Other: Retrieving of retrospective data from Epic

Interventions

Retrieving of retrospective data from Epic OTHER

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.

Patients who received intravenous PCA following surgery at the UHN

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Agnosia; Acute Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain

Study Officials

• Laura Giron-Arango, MD

  UHN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: July 11, 2024
• Primary Completion: December 31, 2024
• Study Completion: February 28, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)