Dataset Information

The Perioperative Pain Self-Management (PePS) randomized controlled trial protocol: Preventing chronic post-surgical pain and prolonged opioid use.

ABSTRACT:

Background

Total joint arthroplasties are common orthopedic surgeries that carry risk for developing chronic post-surgical pain. In addition to pre- and post-operative pain severity, psychological distress (e.g., anxiety, pain catastrophizing) is a risk factor for chronic postsurgical pain. Cognitive behavioral therapy (CBT) for chronic pain is an empirically supported approach to managing chronic pain, functional impairment, and related distress. While CBT has been used extensively in patients with established chronic pain, using it as a preventive intervention targeting the transition from acute to chronic postsurgical pain is a novel application.

Objectives

The Perioperative Pain Self-Management (PePS) program is a pain self-management intervention based on the principles of CBT. This innovative intervention is brief, flexible, and is delivered remotely. 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-surgery. The current study also aims to evaluate the context for subsequent implementation.

Methods

This study is a hybrid type I efficacy-preparing for implementation trial. It is a two-site, single-blind, two-arm, parallel, randomized control trial. Surgical patients will be randomized to either receive: 1) PePS plus standard care, or 2) Standard care. The primary end point will be surgical site pain severity at 6-months post-surgery.

Conclusion

Results from this study are expected to result in support for a brief scalable intervention (PePS) that can prevent the development of chronic pain and prolonged post-surgical opioid use, as well as key details to inform subsequent implementation.

Clinicaltrials

govIdentifier:NCT04979429.

SUBMITTER: Hadlandsmyth K

PROVIDER: S-EPMC10498437 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The Perioperative Pain Self-Management (PePS) randomized controlled trial protocol: Preventing chronic post-surgical pain and prolonged opioid use.

Hadlandsmyth Katherine K Burgess Diana J DJ Leparski Ryan F RF Odom Annie S AS Campbell Emily J EJ Obrecht Ashlie A AA Adamowicz Jenna L JL Cho Hyunkeun H Steffensmeier Kenda Stewart KS Johnson Nicole L NL Richards Christopher C CC Vander Weg Mark W MW Lund Brian C BC Yoon Patrick P Mosher Hilary J HJ

Contemporary clinical trials 20220531

<h4>Background</h4>Total joint arthroplasties are common orthopedic surgeries that carry risk for developing chronic post-surgical pain. In addition to pre- and post-operative pain severity, psychological distress (e.g., anxiety, pain catastrophizing) is a risk factor for chronic postsurgical pain. Cognitive behavioral therapy (CBT) for chronic pain is an empirically supported approach to managing chronic pain, functional impairment, and related distress. While CBT has been used extensively in p ...[more]

PMID: 35660486

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Project description:BackgroundPreoperative patient-specific risk factors may elucidate the mechanisms leading to the persistence of pain and opioid use after surgery. This study aimed to determine whether similar or discordant preoperative factors were associated with the duration of postoperative pain and opioid use.MethodsIn this post hoc analysis of a randomized, double-blind, placebo-controlled trial of perioperative gabapentin vs active placebo, 410 patients aged 18-75 years, undergoing diverse operations underwent preoperative assessments of pain, opioid use, substance use, and psychosocial variables. After surgery, a modified Brief Pain Inventory was administered over the phone daily up to 3 months, weekly up to 6 months, and monthly up to 2 years after surgery. Pain and opioid cessation were defined as the first of 5 consecutive days of 0 out of 10 pain or no opioid use, respectively.ResultsOverall, 36.1%, 19.8%, and 9.5% of patients continued to report pain, and 9.5%, 2.4%, and 1.7% reported continued opioid use at 3, 6, and 12 months after surgery. Preoperative pain at the future surgical site (every 1-point increase in the Numeric Pain Rating Scale; HR 0.93; 95% CI 0.87-1.00; P=0.034), trait anxiety (every 10-point increase in the Trait Anxiety Inventory; HR 0.79; 95% CI 0.68-0.92; P=0.002), and a history of delayed recovery after injury (HR 0.62; 95% CI 0.40-0.96; P=0.034) were associated with delayed pain cessation. Preoperative opioid use (HR 0.60; 95% CI 0.39-0.92; P=0.020), elevated depressive symptoms (every 5-point increase in the Beck Depression Inventory-II score; HR 0.88; 95% CI 0.80-0.98; P=0.017), and preoperative pain outside of the surgical site (HR 0.94; 95% CI 0.89-1.00; P=0.046) were associated with delayed opioid cessation, while perioperative gabapentin promoted opioid cessation (HR 1.37; 95% CI 1.06-1.77; P=0.016).ConclusionSeparate risk factors for prolonged post-surgical pain and opioid use indicate that preoperative risk stratification for each outcome may identify patients needing personalized care to augment universal protocols for perioperative pain management and conservative opioid prescribing to improve long-term outcomes.

Dataset Information

The Perioperative Pain Self-Management (PePS) randomized controlled trial protocol: Preventing chronic post-surgical pain and prolonged opioid use.

Background

Objectives

Methods

Conclusion

Clinicaltrials

Publications

The Perioperative Pain Self-Management (PePS) randomized controlled trial protocol: Preventing chronic post-surgical pain and prolonged opioid use.

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