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

Trial Summary

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 data supports the effectiveness of the treatment COMPAS Participants for pain management in surgery?

Research shows that improving postoperative pain management through quality improvement projects and evidence-based interventions can lead to better patient outcomes and satisfaction. For example, a project in Wisconsin hospitals showed significant improvements in pain management quality indicators, and a nationwide project demonstrated increased use of effective pain management practices. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

Research shows that while older pain treatments like opioids and NSAIDs have known safety profiles, newer treatments such as pregabalin and gabapentin are still being evaluated for safety in surgical settings. Incident reporting in pain management has identified preventable issues, often related to human factors, highlighting the importance of careful monitoring and reporting to ensure safety. ^{6 7 8 9 10}

How does this treatment for surgical pain differ from other treatments?

This treatment is unique because it aims to address the unmet need for effective surgical pain management by potentially incorporating new guidelines and best practices identified by the Surgical Pain Congress™, which focuses on improving patient outcomes and satisfaction. ^{2 11 12 13 14}

What is the purpose of this 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 in orthopedic patients. The study's goal following the data collection is to predict which patients are at high risk for chronic opioid use.

Research Team

Michael Bullock, MD

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Does patient satisfaction correlate with pain level during patient-monitored epidural analgesia. Evaluation of data from postoperative pain service]. [2018]

2. United States 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™. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a local cooperative project to improve postoperative pain management in Wisconsin hospitals. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The Perioperative Pain Management Bundle is Feasible: Findings From the PAIN OUT Registry. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Institutionalizing pain management: the Post-Operative Pain Management Quality Improvement Project. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Opioid-related adverse drug events in surgical hospitalizations: impact on costs and length of stay. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Adverse event assessment and reporting in trials of newer treatments for post-operative pain. [2018]

8. New Zealand 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. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Recommendations for Intraoperative Adverse Events Data Collection in Clinical Studies and Study Protocols. An ICARUS Global Surgical Collaboration Study. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Incident reporting in acute pain management. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

[Postoperative pain therapy in Germany]. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Management of perioperative pain in hospitalized patients: a national survey. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Pain prevalence in hospitalized patients in a German university teaching hospital. [2022]

14. Germany pubmed.ncbi.nlm.nih.gov

[Evaluation of the "initiative pain-free clinic" for quality improvement in postoperative pain management. A prospective controlled study]. [2021]