AnalgesiaNCT06506110
PASS Pain After Surgery
An observational study of Analgesia, run by University Health Network, Toronto at 1 site in Canada.
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.
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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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)
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
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
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
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.
- First posted17 Jul 2024
- Study start11 Jul 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Retrospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Giron-Arango, MD, Principal investigator, UHN
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
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Patient Acceptable Symptom State (PASS) for Acute Pain After Surgery - A Retrospective Study
- ClinicalTrials.gov ID
- NCT06506110
- Acronym / sponsor ID
- 24-5290
- Conditions
- Analgesia
- Keywords
- PASS, MCID, NRS pain score, Acute pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 11 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 17 Jul 2024 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who received intravenous PCA following surgery at the UHN | – | Other: Retrieving of retrospective data from EpicPatients who received intravenous PCA following surgery at the UHN from the period of June 4, 2022 to December 31, 2023. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Use of epidural analgesia in the first 48 hours after surgery
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 |
|---|---|---|
| Retrieving of retrospective data from EpicRetrospective 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. | Other | Patients who received intravenous PCA following surgery at the UHN |
Primary outcome
PASS for the NRS
Time frame: First 48 hours after surgery
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.
4 secondary outcomes
Consistency of PASS for the NRS
Time frame: First 48 hours after surgery
Patient and procedure factors associated with PASS for the NRS
Time frame: First 48 hours after surgery
Opioid dose needed to achieve PASS for the NRS
Time frame: First 48 hours after surgery
MCID for the NRS
Time frame: First 48 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Laura Giron-Arango, MD principal investigator
UHN
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 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.