Pain Self-Management for Postoperative Pain

(PePS Trial)

Not currently recruiting at 2 trial locations

Overseen By Katherine E Hadlandsmyth, PhD MA MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Bipolar, Psychotic disorder, Brain injury, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if teaching patients to manage their own pain can aid recovery after surgery, alongside regular medical care. It focuses on patients undergoing hip, knee, or shoulder joint surgery. Participants will either receive standard care or engage in phone-based sessions that teach pain management techniques through the Perioperative Pain Self-management (PePS) program. This study may suit those scheduled for joint replacement surgery at specific VA medical centers and who have regular phone access. As an unphased trial, it offers a unique opportunity to contribute to innovative pain management strategies and enhance recovery experiences.

Do I need to stop taking my current medications for this trial?

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

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on teaching pain self-management alongside your existing medical pain management.

What prior data suggests that this pain self-management approach is safe?

Research has shown that the Perioperative Pain Self-management (PePS) program might help reduce long-term pain after surgery. The PePS program teaches patients to manage their pain with a clear plan. Although studies do not provide specific safety details for PePS, it uses safe methods like phone coaching, suggesting it poses low risk.

Since PePS does not involve medication and focuses on behavior, most people can likely handle it easily. It complements regular post-surgery care, adding to rather than replacing standard medical treatment. This approach aims to empower patients to manage their pain effectively, making it a safe and supportive addition to traditional pain management methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PePS approach for managing postoperative pain because it introduces a novel method of incorporating cognitive-behavioral therapy (CBT) through telephone sessions. Unlike standard postoperative care, which typically relies on medications like opioids and NSAIDs, PePS emphasizes active pain self-management, empowering patients to take control of their recovery. This method has the potential to reduce reliance on pain medications, thereby minimizing associated side effects and risks, while promoting quicker and more sustainable pain relief.

What evidence suggests that the Perioperative Pain Self-management (PePS) program is effective for postoperative pain?

Research shows that the Perioperative Pain Self-management (PePS) program, which participants in this trial may receive, might help manage pain after surgery. Studies have found that PePS can improve pain control and reduce the need for opioids. In one study, patients using PePS experienced less disruption in their daily lives due to pain. Another study showed that PePS decreased the risk of long-term pain and reduced opioid use six months after surgery. These findings suggest that PePS could be a useful addition to standard care for managing post-surgical pain. ^{1 2 3 4 6}

Who Is on the Research Team?

Katherine E Hadlandsmyth, PhD MA MS

Principal Investigator

Iowa City VA Health Care System, Iowa City, IA

Are You a Good Fit for This Trial?

This trial is for patients scheduled for hip, knee, or shoulder joint replacement at select VA medical centers in Iowa City, Des Moines, Minneapolis, or Milwaukee. Participants must be able to complete forms and have phone access. Those with severe mental health conditions, recent brain injury, dementia or recent CBT therapy cannot join.

Inclusion Criteria

I am scheduled for a hip, knee, or shoulder replacement surgery at specified VA centers.

Exclusion Criteria

Inability to complete study forms/procedures because of a language/literacy barrier

I have undergone CBT therapy in the last year.

I do not have an active bipolar or psychotic disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Intervention

Participants receive 4 sessions of telephone CBT-based pain self-management in addition to standard perioperative care

4 weeks

4 sessions (telephone)

Post-surgery Monitoring

Participants' opioid and analgesic use is monitored via weekly phone calls for the first 6 weeks post-surgery

6 weeks

6 calls (weekly)

Follow-up

Participants are monitored for pain, mood, and functioning outcomes at 6 months post-surgery

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Perioperative Pain Self-management (PePS)

Trial Overview The study tests a Perioperative Pain Self-management (PePS) program designed to teach surgical patients how to manage their pain alongside standard medical care after surgery.

How Is the Trial Designed?

Group I: PePS Experimental Treatment 1 Intervention

4 sessions of telephone CBT-based pain self-management in addition to standard perioperative care.

Group II: Standard Care Active Control 1 Intervention

Standard perioperative care.

Perioperative Pain Self-management (PePS) is already approved in United States for the following indications:

Approved in United States as PePS for:

• Post-surgical pain management

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Effective postoperative pain management is crucial and should be systematic, utilizing a variety of methods tailored to individual patient needs and circumstances, including physician expertise and available resources.

Opioids remain the cornerstone of pain management, and techniques like thoracic epidural analgesia (TEA) combined with local anesthetics can significantly benefit high-risk patients, emphasizing the importance of a balanced analgesic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain management. Jain, S., Datta, S.[2005]

The Perioperative Pain Self-management (PePS) intervention was beneficial for both preoperatively distressed and non-distressed patients, with distressed participants finding pain reframing techniques most helpful, while non-distressed participants preferred relaxation skills.

Both groups highlighted the importance of social support during the intervention, suggesting that personalized approaches may enhance pain management strategies for different patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Preoperative Distress: A Qualitative analysis of the Perioperative Pain Self-Management Intervention. Steffensmeier, KS., Van Tiem, J., Obrecht, A., et al.[2023]

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]

Effective management of postoperative pain is crucial as it can lead to benefits such as reduced hospital stays, lower costs, and increased patient satisfaction, but it must be personalized based on individual patient needs.

Despite the importance of pain management, it remains underutilized due to challenges like insufficient education, fear of complications from analgesics, and inadequate pain assessment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical aspects of acute post-operative pain management & its assessment. Gupta, A., Kaur, K., Sharma, S., et al.[2022]

A study involving 100 subjects from four public hospitals in Mexico revealed that many children, including 30 newborns, received inadequate pain management after surgery, with common analgesics like paracetamol and dipyrone often administered at low doses.

The study highlighted significant gaps in pain documentation and management practices, indicating a need for improved training for healthcare professionals in evaluating and treating postoperative pain in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Errors in managing postsurgical pediatric pain in Mexico. Bravo Matus, CA., Flores Zúñiga, RM.[2011]

Regular pain measurement and documentation by nurses, along with proper analgesic prescriptions, are crucial for effective postoperative pain management in small hospitals.

Implementing a nurse-based acute pain service with patient-controlled analgesia (PCA) systems can enhance patient comfort and satisfaction, potentially leading to shorter hospital stays in fast-track rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Organization model for postoperative pain management in a basic-care hospital]. Bernd, W., Seintsch, H., Amstad, R., et al.[2018]

A quality assurance program for postoperative pain management (POPM) introduced over 3 years ago has led to significant improvements in pain management routines and patient satisfaction on surgical wards, as evidenced by survey data from 110 patients and 51 staff members.

The program, which utilized a nurse-based anesthesiologist-supervised model, resulted in better preoperative information and discussions about pain management, ultimately enhancing staff confidence and reducing reported pain and discomfort in patients post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain management on surgical wards--do quality assurance strategies result in long-term effects on staff member attitudes and clinical outcomes? Stomberg, MW., Wickström, K., Joelsson, H., et al.[2019]

Effective pain management is crucial for children after surgery, as four out of five children experience significant pain postoperatively, which can have lasting negative effects on their health.

Recent advancements in pain management strategies have shown that children can undergo major surgeries with minimal adverse effects when proactive analgesia is provided, highlighting the importance of safe and easy-to-administer pain relief methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current management of pediatric postoperative pain. Kokki, H.[2005]

Patient education is crucial for effective postoperative pain management, yet many hospitals do not implement consistent and complete education practices, which can lead to inadequate pain control despite opioid use.

This review of 12 studies highlights the importance of tailored educational interventions, including optimal timing, delivery methods, and a multidisciplinary approach, to improve patient understanding and safety in opioid use after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Perioperative Pain Education for Patients Prescribed Opioids: An Integrative Review. Lee, YJ., Rosenberg, C.[2023]

A study involving 21 U.S. Military Veterans revealed that patients felt ambivalent about using opioids post-surgery, indicating a need for better education on pain management options.

Participants reported that learning pain self-management skills helped them reduce their reliance on opioids, leading to longer intervals between doses and increased confidence in managing their pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Military Veterans' Perspectives on Postoperative Opioid Use: A Secondary Analysis of Qualitative Data. Conrad, M., Steffensmeier, KS., Van Tiem, J., et al.[2023]

A survey of 80 Dutch hospitals revealed that 90% have an Acute Pain Service (APS), which plays crucial roles in patient rounds, pain education, and quality improvement in pain management.

Despite the presence of APSs, nearly half of the hospitals do not provide regular pain training, and 13% do not offer any patient information about pain management, indicating gaps in postoperative pain management practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute pain services and postsurgical pain management in the Netherlands: a survey. van Boekel, RL., Steegers, MA., Verbeek-van Noord, I., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10498437/

Preventing Chronic Post-Surgical Pain and Prolonged Opioid ... The perioperative pain self-management (PePS) randomized controlled trial protocol: preventing chronic post-surgical pain and prolonged opioid use.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33351478/

A Pilot Randomized Trial of the Perioperative Pain Self ... The findings from this study support the feasibility and preliminary efficacy of the PePS intervention.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422001367

Preventing chronic post-surgical pain and prolonged ... The current study aims to determine the efficacy of PePS compared to standard care on reducing the incidence of significant surgical site pain at 6-months post- ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04979429

Study Details | NCT04979429 | The Perioperative Pain Self ... The Perioperative Pain Self-management (PePS) program has the potential to reduce the incidence of chronic post-surgical pain and long-term opioid use among ...

5. rapm.bmj.com rapm.bmj.com/content/50/2/93

Upskilling pain relief after surgery: a scoping review of ... One perioperative study demonstrated analgesic benefits and reduced opioid use 28 days after surgery (N=118); another (N=48) reported improved pain interference ...

6. withpower.com withpower.com/trial/phase-pain-postoperative-7-2021-5b506

Pain Self-Management for Postoperative Pain (PePS Trial) The available research does not provide specific safety data for the Pain Self-Management for Postoperative Pain treatment, but it suggests that effective pain ...