Pain ManagementNCT04811209
MCID and PASS for Acute Pain and Quality of Recovery After Orthopedic Surgery
An observational study of Pain Management, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This study seeks to define what constitutes an MCID and a PASS in patients undergoing a variety of elective major orthopedic surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain Management
- What is being tested?
- 1.Baseline Measurements Before Surgery, 2.Intraoperative Anesthetic Management and 3.Postoperative Analgesic Management
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jun 2021to 31 Dec 2026
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: Study patients will be recruited at Toronto Western Hospital
Who may be able to join
- Adult patients aged 18-80 years
- ASA class I - III
- Primary elective surgery
- unilateral major shoulder surgery e.g., stabilization and arthroplasty procedures:
- unilateral total hip replacement
- unilateral total knee replacement, and
- spinal decompression + fusion involving ≥ 2 levels.
- Hospital admission for ≥ 24 hours after the surgery
Who cannot join
- Inability to give informed consent
- Poor English comprehension
- Psychiatric disorders e.g., dementia
- Known allergies to morphine / hydromorphone
- Chronic substance abuse and use of recreational drugs
- Any medical disorder that impairs accurate and objective completion of questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anahi Perlas, MD, FRCPC contact
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hopspital
Toronto, Ontario, M5T2S8
Jayanta Chowdhury, MBBS, MD, 4166035800 ext. 2016, jayanta.chowdhury@uhn.ca
Anahi Perlas, MD, FRCPC
About this study
Official title: Determining the Minimum Clinically Important Difference (MCID) and Patient Acceptable Symptom State (PASS) for Acute Pain and Quality of Recovery After Orthopedic Surgery
This study seeks to define what constitutes an MCID and a PASS in patients undergoing a variety of elective major orthopedic surgery.
Read the detailed description
Acute postoperative pain after orthopaedic surgery is common and approximately 40% of all surgical patients experience moderate-severe acute postoperative pain. Treatment of acute pain after surgery is important to relieve patient suffering, expedite resumption of activities of daily living, mitigate the risk of postoperative complications, speed ambulation and rehabilitation and hospital discharge. Good pain treatment requires proper and sound pain assessment to guide analgesic therapy. Past studies have determined the MCID values for a variety of chronic pain disorders. There are however limited data on the MCID for acute pain.At the present time, most perioperative acute pain studies use MCID values that are extrapolated from chronic pain studies yet the validity of MCID extrapolation remains unknown. Procedure-specific MCID for pain after most major orthopedic surgery has not been reported.The MCID for a patient reported outcome can be determined using an anchor and a distribution based method.The anchor based method uses a subjective Global Rating Scale (GRS) scale to assess patient's perception of pain relief after treatment. This is a 15-point Likert scale that ranges from -7 to +7 .Another method to determine the MCID value in pain is the distribution based method using mathematical calculations to generate 3 MCID values - 1) 0.3 standard deviation (SD) of mean change in NRS scores, 2) the standard error of measurement (SEM), and 3) 5% of the instrument range of the mean change in the NRS scores after an analgesic intervention according to patient-rated GAR scale. The SEM is calculated as the SD multiplied by the square root of 1 minus the intraclass correlation coefficient. The final MCID value is the average of 4 values, 1 generated from the anchored and 3 generated from the distribution based methods.
The Patient Acceptable Symptom State (PASS) is another measure for patient-reported outcomes. It represents the threshold beyond which patients consider themselves well (satisfied) after an intervention. The PASS is an absolute value, not a change but this value will vary among patients. In essence, PASS indicates a state of wellbeing (feeling good) as opposed to MCID, a state of improvement (feeling better). The 2 concepts are complementary but contrary to MCID, the PASS is the outcome of interest, instead of the extent of improvement. To determine PASS, the patients are asked this question "In your opinion, do you consider your current pain state satisfactory after your operation?" Patients responding "yes" are considered having an acceptable pain state. The PASS is the 75th centile of the pain scale in those who rated their pain state as satisfactory. Higher baseline pain scores are often associated with higher PASS estimates. Little is known about PASS for acute pain after surgery thus a need to determine this benchmark to properly evaluate the clinical benefits of analgesic interventions.
Quality of Recovery (QoR) is another important PRO measure when evaluating the impact of novel intervention strategies. Quality of recovery can be assessed using the QoR-15 questionnaire (scores 0-150) which measures physical \& mental well-being as an indication of the quality of recovery after surgery and anaesthesia.
To determine MCID for QoR, both the anchor and distribution based methods will be used. The patient will be asked "How would you rate your overall recovery from surgery since yesterday?" Patients will use the same GRS (-7 to +7) to measure their response. With the anchored-based method, the MCID is the mean change in the QoR-15 score when the patient reports a GRS score of +2 or +3. The distribution-based method will generate 3 other MCID values: 1) 0.3 standard deviation (SD) of the mean change in the QoR score; 2) the standard error of measurement (SEM); and 3) 5% of the instrument range. Again, the final MCID value is the average of 4 values, 1 generated from the anchored and 3 generated from the distribution based methods.
To determine PASS for QoR, the patients will be asked, "In your opinion, have you made a good recovery from your operation?" with response options of yes, no, or unsure. Those who give a positive response is considered having made a good recovery. The PASS for QoR is the 75th centile of the QoR-15 score in those who rated their recovery as good. The only MCID and PASS study by Myles reported a QoR-15 score of 8 \& 118 (out of 150), respectively, in patients undergoing a broad range of surgical procedures. Procedure-specific MCID \& PASS for QoR-15 after major orthopaedic surgery are currently unknown. Our proposed observational study seeks to define what constitutes an MCID and a PASS in patients undergoing a variety of elective major orthopedic surgery.
- Conditions
- Pain Management
- Being tested
- 1.Baseline Measurements Before Surgery, 2.Intraoperative Anesthetic Management, 3.Postoperative Analgesic Management, 4.Postoperative NRS Pain Assessment, 5.Postoperative Global Rating Scale (GRS) Pain Assessment
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1.Baseline Measurements Before SurgeryOther
- Baseline demographic data
- Baseline physiological variables (blood pressure, heart rate, respiratory rate, oxygen saturation)
- Baseline investigations (hemoglobin, coagulation profile, serum electrolytes) if appropriate.
- Preoperative pain state using NRS (0-10)
- Preoperative functional state using the QoR-15 questionnaire
- Pain expectation - patients will be asked preoperatively with the question "In a scale from 0 to 10 (where 0 = no pain and 10 = worst pain imaginable), what do you consider is an acceptable pain score for your first (and second) day after surgery?... Two weeks after surgery?"
- Pain castastrophizing scale
2.Intraoperative Anesthetic ManagementOther
All study patients will be managed per routine clinical practice and institutional standard for the performed surgery.
3.Postoperative Analgesic ManagementOther
postoperative pain will be managed on the ward using a multimodal analgesic regimen as appropriate. This includes:
- acetaminophen 650 - 1,000 mg given orally every 6 hours around the clock
- NSAIDs e.g., celecoxib or other agents given orally around the clock per clinical guideline; omit if contraindicated or per surgeon's preference
- Opioids e.g., hydromorphone 1-2 mg or oxycodone 15-30 mg given orally every 1-2 hours as required by the patient per standard nurse administered analgesic protocol.
- In the event of severe pain refractory to the above treatments, the patient will be offered IV opioid e.g., intermittent doses of 0.2-0.4 mg hydromorphone IV every 10 minutes until pain becomes tolerable
4.Postoperative NRS Pain AssessmentOther
Pain assessment using NRS pain scores (0 = no pain and 10 = worst possible pain) will be performed by an independent research staff, starting immediately in the PACU and serially over the first 48 hours after surgery or until hospital discharge.
5.Postoperative Global Rating Scale (GRS) Pain AssessmentOther
Also, the degree of pain relief after treatment is assessed using a subjective 15-point Global Rating Scale (GRS) as mentioned above (Background). This is performed at the same time of each NRS assessment and a minimum of twice daily
6.Postoperative Patient Acceptable Symptom State (PASS) Assessment for PainOther
During each NRS pain assessment before or after an analgesic intervention on POD 0, 1 and 2, the patient will also be asked this question- ""In your opinion, do you consider your current pain state satisfactory after your operation?" Patients giving a positive response are considered having an acceptable pain state. The PASS is the 75th centile for the pain NRS score in those with a satisfactory pain state.
7.Postoperative Quality of Recovery AssessmentOther
The quality of recovery 15 questionnaire (QoR-15) to measure the dimension of quality of recovery will be administered once in the morning of POD 1 and POD 2. The MCID and PASS for QoR are determined in the same way as for NRS score. The final MCID value will be average of 4 values, 1 generated by the anchor based method and 3 generated by the distribution based method. The PASS for QoR is the 75th centile of the QoR-15 score in those patients who rated their recovery as good.
8.Other Postoperative AssessmentsOther
Additionally, opioid related adverse effects e.g., nausea, vomiting, itchiness, constipation, sedation (RASS + Ramsay)/ and respiratory depression will be assessed daily.
| Study group | Role | What they receive |
|---|---|---|
| single group, open labelled observational study with no blinding. | All study patients will be managed per routine clinical practice and institutional standard for the performed surgery. Receives: Other: 1.Baseline Measurements Before Surgery; Other: 2.Intraoperative Anesthetic Management; Other: 3.Postoperative Analgesic Management; Other: 4.Postoperative NRS Pain Assessment; Other: 5.Postoperative Global Rating Scale (GRS) Pain Assessment; Other: 6.Postoperative Patient Acceptable Symptom State (PASS) Assessment for Pain; Other: 7.Postoperative Quality of Recovery Assessment; Other: 8.Other Postoperative Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
MCID for NRS pain score after orthopedic surgery
The MCID value represents the change in NRS score after treatment when the patient reports a small improvement of pain relief that corresponds to a GAR score of 2 or 3.
Measured: The first 48 hours after 4 types of major orthopedic
Secondary outcomes (5)
The PASS for NRS pain score after orthopedic surgery
The PASS for NRS pain score after orthopedic surgery
Measured: The first 48 hours after 4 types of major orthopedic
The amount of opioid consumption required to achieve MCID and PASS
The amount of opioid consumption required to achieve MCID and PASS for acute pain after orthopedic surgery.
Measured: The first 48 h hours 4 types of major orthopedic
Quality of recovery
Quality of recovery as assessed using the QoR-15 questionnaire (0-150), higher score means better recovery
Measured: The first 2 days after surgery
The MCID and PASS for QoR-15
The MCID and PASS for QoR-15 (0-150), higher score means better recovery
Measured: The first 2 days after surgery
The incidence of opioid related adverse reactions and treatments required
The incidence of opioid related adverse reactions and treatments required
Measured: The first 2 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start21 Jun 2021
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anahi Perlas, MD, FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04811209
- Sponsor's protocol ID
- 20-6059
- Status last verified
- Jun 2026
- First submitted
- 17 Mar 2021
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Minimum Clinically Important Difference (MCID) and Patient Acceptable Symptom State (PASS) for Acute Pain and Quality of Recovery After Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT04811209
- Acronym / sponsor ID
- 20-6059
- Conditions
- Pain Management
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Mar 2021 (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.
This study seeks to define what constitutes an MCID and a PASS in patients undergoing a variety of elective major orthopedic surgery.
Detailed description
Acute postoperative pain after orthopaedic surgery is common and approximately 40% of all surgical patients experience moderate-severe acute postoperative pain. Treatment of acute pain after surgery is important to relieve patient suffering, expedite resumption of activities of daily living, mitigate the risk of postoperative complications, speed ambulation and rehabilitation and hospital discharge. Good pain treatment requires proper and sound pain assessment to guide analgesic therapy. Past studies have determined the MCID values for a variety of chronic pain disorders. There are however limited data on the MCID for acute pain.At the present time, most perioperative acute pain studies use MCID values that are extrapolated from chronic pain studies yet the validity of MCID extrapolation remains unknown. Procedure-specific MCID for pain after most major orthopedic surgery has not been reported.The MCID for a patient reported outcome can be determined using an anchor and a distribution based method.The anchor based method uses a subjective Global Rating Scale (GRS) scale to assess patient's perception of pain relief after treatment. This is a 15-point Likert scale that ranges from -7 to +7 .Another method to determine the MCID value in pain is the distribution based method using mathematical calculations to generate 3 MCID values - 1) 0.3 standard deviation (SD) of mean change in NRS scores, 2) the standard error of measurement (SEM), and 3) 5% of the instrument range of the mean change in the NRS scores after an analgesic intervention according to patient-rated GAR scale. The SEM is calculated as the SD multiplied by the square root of 1 minus the intraclass correlation coefficient. The final MCID value is the average of 4 values, 1 generated from the anchored and 3 generated from the distribution based methods.
The Patient Acceptable Symptom State (PASS) is another measure for patient-reported outcomes. It represents the threshold beyond which patients consider themselves well (satisfied) after an intervention. The PASS is an absolute value, not a change but this value will vary among patients. In essence, PASS indicates a state of wellbeing (feeling good) as opposed to MCID, a state of improvement (feeling better). The 2 concepts are complementary but contrary to MCID, the PASS is the outcome of interest, instead of the extent of improvement. To determine PASS, the patients are asked this question "In your opinion, do you consider your current pain state satisfactory after your operation?" Patients responding "yes" are considered having an acceptable pain state. The PASS is the 75th centile of the pain scale in those who rated their pain state as satisfactory. Higher baseline pain scores are often associated with higher PASS estimates. Little is known about PASS for acute pain after surgery thus a need to determine this benchmark to properly evaluate the clinical benefits of analgesic interventions.
Quality of Recovery (QoR) is another important PRO measure when evaluating the impact of novel intervention strategies. Quality of recovery can be assessed using the QoR-15 questionnaire (scores 0-150) which measures physical \& mental well-being as an indication of the quality of recovery after surgery and anaesthesia.
To determine MCID for QoR, both the anchor and distribution based methods will be used. The patient will be asked "How would you rate your overall recovery from surgery since yesterday?" Patients will use the same GRS (-7 to +7) to measure their response. With the anchored-based method, the MCID is the mean change in the QoR-15 score when the patient reports a GRS score of +2 or +3. The distribution-based method will generate 3 other MCID values: 1) 0.3 standard deviation (SD) of the mean change in the QoR score; 2) the standard error of measurement (SEM); and 3) 5% of the instrument range. Again, the final MCID value is the average of 4 values, 1 generated from the anchored and 3 generated from the distribution based methods.
To determine PASS for QoR, the patients will be asked, "In your opinion, have you made a good recovery from your operation?" with response options of yes, no, or unsure. Those who give a positive response is considered having made a good recovery. The PASS for QoR is the 75th centile of the QoR-15 score in those who rated their recovery as good. The only MCID and PASS study by Myles reported a QoR-15 score of 8 \& 118 (out of 150), respectively, in patients undergoing a broad range of surgical procedures. Procedure-specific MCID \& PASS for QoR-15 after major orthopaedic surgery are currently unknown. Our proposed observational study seeks to define what constitutes an MCID and a PASS in patients undergoing a variety of elective major orthopedic surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group, open labelled observational study with no blinding. | – | Other: 1.Baseline Measurements Before Surgery, Other: 2.Intraoperative Anesthetic Management, Other: 3.Postoperative Analgesic Management, Other: 4.Postoperative NRS Pain Assessment, Other: 5.Postoperative Global Rating Scale (GRS) Pain Assessment, Other: 6.Postoperative Patient Acceptable Symptom State (PASS) Assessment for Pain, Other: 7.Postoperative Quality of Recovery Assessment, Other: 8.Other Postoperative AssessmentsAll study patients will be managed per routine clinical practice and institutional standard for the performed surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study patients will be recruited at Toronto Western Hospital
Key inclusion criteria (8 listed)
- Adult patients aged 18-80 years
- ASA class I - III
- Primary elective surgery
- unilateral major shoulder surgery e.g., stabilization and arthroplasty procedures:
- unilateral total hip replacement
Key exclusion criteria (6 listed)
- Inability to give informed consent
- Poor English comprehension
- Psychiatric disorders e.g., dementia
- Known allergies to morphine / hydromorphone
- Chronic substance abuse and use of recreational drugs
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 |
|---|---|---|
| 1.Baseline Measurements Before Surgery* Baseline demographic data * Baseline physiological variables (blood pressure, heart rate, respiratory rate, oxygen saturation) * Baseline investigations (hemoglobin, coagulation profile, serum electrolytes) if appropriate. * Preoperative pain state using NRS (0-10) * Preoperative functional state using the QoR-15 questionnaire * Pain expectation - patients will be asked preoperatively with the question "In a scale from 0 to 10 (where 0 = no pain and 10 = worst pain imaginable), what do you consider is an acceptable pain score for your first (and second) day after surgery?... Two weeks after surgery?" * Pain castastrophizing scale | Other | single group, open labelled observational study with no blinding. |
| 2.Intraoperative Anesthetic ManagementAll study patients will be managed per routine clinical practice and institutional standard for the performed surgery. | Other | single group, open labelled observational study with no blinding. |
| 3.Postoperative Analgesic Managementpostoperative pain will be managed on the ward using a multimodal analgesic regimen as appropriate. This includes: 1. acetaminophen 650 - 1,000 mg given orally every 6 hours around the clock 2. NSAIDs e.g., celecoxib or other agents given orally around the clock per clinical guideline; omit if contraindicated or per surgeon's preference 3. Opioids e.g., hydromorphone 1-2 mg or oxycodone 15-30 mg given orally every 1-2 hours as required by the patient per standard nurse administered analgesic protocol. 4. In the event of severe pain refractory to the above treatments, the patient will be offered IV opioid e.g., intermittent doses of 0.2-0.4 mg hydromorphone IV every 10 minutes until pain becomes tolerable | Other | single group, open labelled observational study with no blinding. |
| 4.Postoperative NRS Pain AssessmentPain assessment using NRS pain scores (0 = no pain and 10 = worst possible pain) will be performed by an independent research staff, starting immediately in the PACU and serially over the first 48 hours after surgery or until hospital discharge. | Other | single group, open labelled observational study with no blinding. |
| 5.Postoperative Global Rating Scale (GRS) Pain AssessmentAlso, the degree of pain relief after treatment is assessed using a subjective 15-point Global Rating Scale (GRS) as mentioned above (Background). This is performed at the same time of each NRS assessment and a minimum of twice daily | Other | single group, open labelled observational study with no blinding. |
| 6.Postoperative Patient Acceptable Symptom State (PASS) Assessment for PainDuring each NRS pain assessment before or after an analgesic intervention on POD 0, 1 and 2, the patient will also be asked this question- ""In your opinion, do you consider your current pain state satisfactory after your operation?" Patients giving a positive response are considered having an acceptable pain state. The PASS is the 75th centile for the pain NRS score in those with a satisfactory pain state. | Other | single group, open labelled observational study with no blinding. |
| 7.Postoperative Quality of Recovery AssessmentThe quality of recovery 15 questionnaire (QoR-15) to measure the dimension of quality of recovery will be administered once in the morning of POD 1 and POD 2. The MCID and PASS for QoR are determined in the same way as for NRS score. The final MCID value will be average of 4 values, 1 generated by the anchor based method and 3 generated by the distribution based method. The PASS for QoR is the 75th centile of the QoR-15 score in those patients who rated their recovery as good. | Other | single group, open labelled observational study with no blinding. |
| 8.Other Postoperative AssessmentsAdditionally, opioid related adverse effects e.g., nausea, vomiting, itchiness, constipation, sedation (RASS + Ramsay)/ and respiratory depression will be assessed daily. | Other | single group, open labelled observational study with no blinding. |
Primary outcome
MCID for NRS pain score after orthopedic surgery
Time frame: The first 48 hours after 4 types of major orthopedic
The MCID value represents the change in NRS score after treatment when the patient reports a small improvement of pain relief that corresponds to a GAR score of 2 or 3.
5 secondary outcomes
The PASS for NRS pain score after orthopedic surgery
Time frame: The first 48 hours after 4 types of major orthopedic
The amount of opioid consumption required to achieve MCID and PASS
Time frame: The first 48 h hours 4 types of major orthopedic
Quality of recovery
Time frame: The first 2 days after surgery
The MCID and PASS for QoR-15
Time frame: The first 2 days after surgery
The incidence of opioid related adverse reactions and treatments required
Time frame: The first 2 days 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 10 Jun 2026.
- 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.
Anahi Perlas, MD, FRCPC contact
Anahi Perlas, MD, FRCPC principal investigator
University Health Network, Toronto
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 Pain Management, 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 8 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Jun 2026. 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?
Contact Jayanta Chowdhury, MBBS,MD (4166035800 ext. 2016, jayanta.chowdhury@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MCID for NRS pain score after orthopedic surgery (time frame: The first 48 hours after 4 types of major orthopedic). 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 10 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.