Recruiting

Observational StudyMCID and PASS for Acute Pain and Quality of Recovery After Orthopedic Surgery

Sponsor:

University Health Network, Toronto

Code:

NCT04811209

Conditions

Pain Management

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief summary:

This study seeks to define what constitutes an MCID and a PASS in patients undergoing a variety of elective major orthopedic surgery.

Conditions

Pain Management

Study ID

NCT04811209

Start date

Jun 21, 2021

Status verified date

Jun, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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

2.Intraoperative Anesthetic Management

All study patients will be managed per routine clinical practice and institutional standard for the performed surgery.

3.Postoperative Analgesic Management

postoperative 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

4.Postoperative NRS Pain Assessment

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 Assessment

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 Pain

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 Assessment

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 Assessments

Additionally, opioid related adverse effects e.g., nausea, vomiting, itchiness, constipation, sedation (RASS + Ramsay)/ and respiratory depression will be assessed daily.

Primary outcome measure

MCID for NRS pain score after orthopedic surgery [ Time Frame: The first 48 hours after 4 types of major orthopedic ]

Central Contacts and Locations

Central contacts

Jayanta Chowdhury, MBBS,MD

4166035800 jayanta.chowdhury@uhn.ca

Locations

Toronto Western Hopspital

Recruiting

Toronto, Ontario, Canada, M5T2S8

Contacts

Jayanta Chowdhury, MBBS, MD

4166035800 jayanta.chowdhury@uhn.ca

Principal Investigator:

Anahi Perlas, MD. FRCPC

More Information

Sponsor

University Health Network, Toronto

Last update posted

Jun 10, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-06-10.