Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506110
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
PASS Pain After Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Determining the Patient Acceptable Symptom State PASS for Acute Pain After Surgery - A Retrospective Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg 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 eg 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 scores 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 ie 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 eg 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 patients 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 patients satisfaction yesno 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 eg mean median mode and measures of variability eg 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
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 scores 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 ie 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 eg 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 patients 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 patients satisfaction yesno 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 eg mean median mode and measures of variability eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None