Pain Management for Surgery

(COMPAS Trial)

Overseen By Michael Bullock, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Lacking capacity, Cannot read English

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

10000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand pain management and opioid use after orthopedic surgery. Researchers seek to assess how patients report their pain, their daily functioning, and their opioid medication use at home. The goal is to predict which patients might continue using opioids long-term. Patients undergoing elective orthopedic surgery at Duke Health who have a smartphone may be suitable for this study. As an unphased study, this trial offers a unique opportunity to contribute to important research that could improve future pain management strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this protocol is safe for orthopedic surgery patients?

Research shows that the treatment for COMPAS participants aims to manage pain after surgery. Previous studies have found that improving pain management immediately post-surgery can reduce the risk of long-term opioid use. Although detailed safety information for the COMPAS treatment is not yet available, the treatment remains under study.

The trial is marked as "Not Applicable" for phase, indicating a lack of clear safety data. However, studies typically reach this stage only if earlier research suggests the treatment is likely safe. Additionally, treatments similar to COMPAS have been used effectively for pain management, suggesting some level of safety. Participants should always discuss any concerns with their doctors before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the COMPAS treatment for pain management because it offers a unique approach to handling post-surgical pain after orthopedic procedures. Unlike traditional pain relief methods, such as opioids or NSAIDs, which can have significant side effects or risk of dependency, COMPAS focuses on innovative strategies that may enhance recovery and reduce the need for these medications. This approach could lead to improved patient outcomes by minimizing pain more effectively and safely, addressing a critical need in surgical care.

What evidence suggests that this trial's treatments could be effective for pain management in surgery?

This trial will focus on personalized pain management strategies for orthopedic surgery patients. Research has shown that assessing pain individually and using various treatments can greatly enhance pain management. Treatments can be customized to fit each person's needs, potentially leading to better pain relief. One study found that educating patients about pain management, similar to methods used in cancer care, led to significantly better outcomes. These findings suggest that personalized care and education can help reduce pain and speed up recovery after surgery. Although limited data exists specifically for orthopedic patients, these strategies have shown promise in improving pain management in various contexts. ^{1 3 6 7 8}

Who Is on the Research Team?

Michael Bullock, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for English-reading adults aged 18-90 who are scheduled for elective orthopedic surgery at Duke Health and own a smartphone. It aims to identify those at risk of chronic opioid use after surgery.

Inclusion Criteria

I can read English.

I own a smartphone that runs on either IOS or Android.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Participants' pain, psychosocial outcomes, functionality, and opioid usage are measured

6 months

Regular data collection through mobile application

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• COMPAS Participants

Trial Overview The COMPAS Participants study measures pain, psychosocial outcomes, functionality, and actual opioid usage post-surgery to predict the risk of long-term opioid use in patients.

How Is the Trial Designed?

Group I: COMPAS Participants Experimental Treatment 1 Intervention

Patents between the ages of 18 and 90 who are undergoing orthopedic surgery at Duke Health will be eligible for enrollment.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

Out of 773 surveyed anesthesiology departments in Germany, 36.1% had established an Acute Pain Service (APS), with larger hospitals (≥1000 beds) being more likely to have one compared to smaller hospitals.

Departments with an APS were more likely to utilize advanced pain management techniques, such as epidural analgesia and regional anesthesia methods, indicating that APS may enhance the quality of postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postoperative pain therapy in Germany]. Stamer, U., Mpasios, N., Stüber, F., et al.[2019]

In a 12-month study involving 1275 patients receiving pain management, 53 incidents were reported, with 81.4% deemed preventable, highlighting the potential for improving safety in clinical practices.

Human factors, such as inexperience and communication issues, contributed to 41.9% of incidents, indicating the need for targeted training and better communication strategies to enhance patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incident reporting in acute pain management. Chen, PP., Ma, M., Chan, S., et al.[2022]

Opioid-related adverse drug events (ADEs) significantly increase hospital costs by 7.4% and length of stay (LOS) by 10.3% in surgical patients, indicating a substantial financial impact on healthcare systems.

Patients receiving higher doses of opioids are at a greater risk of experiencing ADEs, suggesting that careful management of opioid dosages is crucial to minimize complications and associated costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid-related adverse drug events in surgical hospitalizations: impact on costs and length of stay. Oderda, GM., Said, Q., Evans, RS., et al.[2022]

Despite advancements in pain management medications, patients have not experienced significant improvements in surgical pain levels over the past 20 years, highlighting a critical gap in effective pain control.

Inadequate pain management can lead to serious consequences, including poor surgical outcomes, increased readmission rates, and higher healthcare costs, underscoring the need for a national consensus on best practices in surgical pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining new directions for more effective management of surgical pain in the United States: highlights of the inaugural Surgical Pain Congress™. Joshi, GP., Beck, DE., Emerson, RH., et al.[2014]

Hospitals certified under the TÜV Rheinland quality management program showed significant improvements in postoperative pain management, with reductions in maximum pain scores and increased patient satisfaction after implementing the program.

Participation in the QUIPS benchmarking project also led to notable improvements in stress pain and patient satisfaction, indicating that both quality management approaches effectively enhance postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the "initiative pain-free clinic" for quality improvement in postoperative pain management. A prospective controlled study]. Lehmkuhl, D., Meissner, W., Neugebauer, EA.[2021]

A review of 90 trials (31 for pregabalin and 59 for gabapentin) showed that only 24% adequately reported adverse events (AEs) at specified perioperative time points, highlighting a significant gap in safety assessment in post-operative pain treatment studies.

Only 7 out of 10 recommendations from the CONSORT Extension for Harms were typically followed, with 18% of trials not describing their AE assessment methods, indicating a need for improved reporting standards to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event assessment and reporting in trials of newer treatments for post-operative pain. Hoffer, D., Smith, SM., Parlow, J., et al.[2018]

A survey of 400 hospitals revealed that 56% responded, with 85% of respondents being board-certified anesthesiologists, indicating a strong representation of qualified professionals in the study.

While there was good adherence to most pain management guidelines, notable gaps included the underutilization of nonpharmacologic pain control methods and a high reliance on intramuscular opioids, especially in smaller hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of perioperative pain in hospitalized patients: a national survey. Carr, DB., Miaskowski, C., Dedrick, SC., et al.[2019]

In a study involving 561 patients at a German university hospital, 50% reported experiencing pain during the interview, with 63% having pain in the previous 24 hours, highlighting a significant prevalence of pain among inpatients.

Despite the high levels of reported pain, 30% of patients with severe pain (VAS ≥ 65 mm) did not receive any analgesics, and 44% of patients had inadequate pain management, indicating a critical need for improved pain assessment and treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain prevalence in hospitalized patients in a German university teaching hospital. Strohbuecker, B., Mayer, H., Evers, GC., et al.[2022]

In a study of 288,912 veterans aged 55 and over, COX-2 inhibitors were more commonly prescribed than non-selective NSAIDs (NS-NSAIDs) for patients with a history of gastrointestinal (GI) events, myocardial infarction (MI), or stroke, indicating a preference for potentially safer options in at-risk populations.

Despite the preference for COX-2 inhibitors, 2.5% of patients with a history of GI events were still using NS-NSAIDs, highlighting a gap in adherence to treatment guidelines that recommend avoiding these medications in high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COX-2 inhibitor and non-selective NSAID use in those at increased risk of NSAID-related adverse events: a retrospective database study. Gadzhanova, S., Ilomäki, J., Roughead, EE.[2021]

A study of 150 adult patients using epidural catheters for postoperative pain management showed that 87.8% rated their pain service as very good or good, indicating high satisfaction with the treatment.

Despite the high satisfaction rates, common side effects included bladder dysfunction (19%) and intermittent motor blockade (18%), particularly with lumbar catheters, highlighting the need for ongoing improvements in pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Does patient satisfaction correlate with pain level during patient-monitored epidural analgesia. Evaluation of data from postoperative pain service]. Gottschalk, A., Freitag, M., Liehr, K., et al.[2018]

A quality improvement project involving 15 hospitals in Wisconsin successfully enhanced the management of postoperative pain for Medicare patients, with data collected from 714 subjects at baseline and 406 subjects after the intervention.

All six evaluated quality indicators showed statistically significant improvement after the project, indicating effective strategies were implemented to better manage pain post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a local cooperative project to improve postoperative pain management in Wisconsin hospitals. Tavris, DR., Dahl, J., Gordon, D., et al.[2019]

The implementation of a 'Perioperative Pain Management Bundle' in 10 hospitals in Serbia significantly reduced multidimensional pain-related patient-reported outcomes (PROs) after surgery, indicating improved pain management practices.

The bundle, which included nonopioid analgesics, local/regional anesthesia, pain assessment, and patient education, showed that while nonopioid analgesics alone did not improve outcomes, the overall bundle led to better pain management compared to partial implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Perioperative Pain Management Bundle is Feasible: Findings From the PAIN OUT Registry. Stamenkovic, D., Baumbach, P., Radovanovic, D., et al.[2023]

The Post-Operative Pain Management Quality Improvement Project (POP Project) involved 233 hospitals and successfully increased the presence of critical structural elements for pain management from 45% to 72% over 12 to 18 months.

While practices improved, such as better use of pain rating scales and nonpharmacologic strategies, patient pain outcomes did not show significant change, indicating a need for further research to connect structural improvements to better patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Institutionalizing pain management: the Post-Operative Pain Management Quality Improvement Project. Dahl, JL., Gordon, D., Ward, S., et al.[2019]

The ICARUS Global Surgical Collaboration has developed a comprehensive system for collecting data on intraoperative adverse events (iAEs), addressing the lack of standardized reporting in surgical literature.

This study provides essential tools, including core-set variables and guidelines for reporting iAEs, which are based on globally validated criteria, aiming to improve patient safety and outcomes in surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for Intraoperative Adverse Events Data Collection in Clinical Studies and Study Protocols. An ICARUS Global Surgical Collaboration Study. Cacciamani, GE., Eppler, M., Sayegh, AS., et al.[2023]

Citations

1. withpower.com withpower.com/trial/phase-4-2021-56316

Pain Management for Surgery (COMPAS Trial) The primary aim of this study is to measure pain and psychosocial patient reported outcomes, objective functionality, and actual daily at home opioid usage ...

2. withpower.com withpower.com/trial/phase-ergonomics-8-2022-162d7

COMPASS-NP for Pain Management (COMPASS-NP Trial) An educational intervention for cancer pain management significantly improved patient outcomes, with trained providers showing a notable reduction in patient ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12147818/

Comprehensive Review on Personalized Pain Assessment ... Emerging evidence indicates that combining personalized pain assessment with multimodal interventions can significantly improve clinical outcomes.

4. researchgate.net researchgate.net/publication/389712657_EFFECTIVENESS_OF_DIFFERENT_PAIN_MANAGEMENT_STRATEGIES_IN_IMPROVING_PAIN_OUTCOMES_AMONG_SURGICAL_PATIENTS_SYSTEMATIC_REVIEW_STUDY

effectiveness of different pain management strategies in ... EFFECTIVENESS OF DIFFERENT PAIN MANAGEMENT STRATEGIES IN IMPROVING PAIN OUTCOMES AMONG SURGICAL PATIENTS: SYSTEMATIC REVIEW STUDY.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11857533/

The Effectiveness of Patient-Controlled Analgesia in ... PCA significantly improves postoperative pain relief (p < 0.05), leading to a 30% reduction in opioid consumption and a 20% shorter hospital ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10088173/

COMMunity of Practice And Safety Support for Navigating ... The COMPASS study did not directly address chronic pain management, and consequently, reductions in pain severity were small and non ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05821699

Effect of Personalized Pain Coaches After Orthopaedic ... This finding suggests that optimizing pain management, soon after painful events, such as orthopaedic injury, is vital to reducing risks related to prolonged ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03834818/collecting-outcomes-and-managing-pain-after-surgery?id=614&slug=surgery

Collecting Outcomes and Managing Pain After Surgery The study's goal following the data collection is to predict which patients are at high risk for chronic opioid use. Eligibility Criteria ...