MCID and PASS for Acute Pain and Quality of Recovery After Orthopedic Surgery

NCT04811209 | Recruiting DMC

• 1 other identifier: 20-6059
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  The first 48 hours after 4 types of major orthopedic

Secondary Outcomes (5)

• The PASS for NRS pain score after orthopedic surgery

  The first 48 hours after 4 types of major orthopedic

• The amount of opioid consumption required to achieve MCID and PASS

  The first 48 h hours 4 types of major orthopedic

• Quality of recovery

  The first 2 days after surgery

• The MCID and PASS for QoR-15

  The first 2 days after surgery

• The incidence of opioid related adverse reactions and treatments required

  The first 2 days after surgery

Study Arms (1)

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.

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

Interventions

2.Intraoperative Anesthetic Management OTHER

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

single group, open labelled observational study with no blinding.

5.Postoperative Global Rating Scale (GRS) Pain Assessment OTHER

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

single group, open labelled observational study with no blinding.

4.Postoperative NRS Pain Assessment OTHER

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.

single group, open labelled observational study with no blinding.

7.Postoperative Quality of Recovery Assessment OTHER

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.

single group, open labelled observational study with no blinding.

3.Postoperative Analgesic Management OTHER

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

single group, open labelled observational study with no blinding.

6.Postoperative Patient Acceptable Symptom State (PASS) Assessment for Pain OTHER

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.

single group, open labelled observational study with no blinding.

1.Baseline Measurements Before Surgery OTHER

* 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

single group, open labelled observational study with no blinding.

8.Other Postoperative Assessments OTHER

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

single group, open labelled observational study with no blinding.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study patients will be recruited at Toronto Western Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hopspital

Toronto, Ontario, M5T2S8, Canada

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

BCL2-related protein A1; Restraint, Physical

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Anahi Perlas, MD, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jayanta Chowdhury, MBBS,MD

CONTACT

4166035800; jayanta.chowdhury@uhn.ca

Anahi Perlas, MD, FRCPC

CONTACT

Study Design

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

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: March 23, 2021
• Study Start: June 21, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)