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Responsible preoperative opioid use for hip or knee arthroplasty (OpioidHALT): a protocol for a randomised clinical trial of pharmacist-partnered opioid tapering prior to hip or knee arthroplasty

Por: Penm · J. · Liu · S. · Adie · S. · Ashton-James · C. E. · Bailey · K. A. · Brady · B. · Chaar · B. · Chen · J. · Descallar · J. · Englezos · K. · Genel · F. · Gillespie · D. · Gnjidic · D. · Hoang · T. · Jansson · A. · Jauregui · K. J. · Keehan · M. · Lin · C.-W. C. · Lintzeris · N. · Luckie
Introduction

Despite limited evidence of efficacy, opioid analgesics are frequently used by patients for chronic pain while awaiting total hip or knee arthroplasty (THA or TKA). Preoperative use of opioids is problematic as it increases the likelihood of postoperative opioid-related adverse drug events and postoperative complications and is the strongest predictor of persistent opioid use post surgery. Opioid tapering prior to elective surgery has been proposed as a strategy for mitigating harms and improving postoperative outcomes. This protocol describes a randomised clinical trial, which aims to determine the effectiveness of a preoperative pharmacist-partnered opioid tapering programme compared with standard care for patients awaiting elective THA or TKA on postoperative outcomes including persistent opioid use.

Method and analysis

Eligible participants must be aged ≥18 years; awaiting elective unilateral or bilateral THA or TKA; speak and read English; use prescription opioid analgesics at least 4 days a week and have access to internet or telephone. The participants will be excluded if they are undergoing a repeat surgery (same procedure within 6 months), are using opioids for cancer, palliative care or substance use disorder; have previously or are currently undergoing an opioid tapering programme or active medication review or have cognitive impairment. Enrolled participants will be randomised in a 1:1 ratio in permuted blocks of two and four to: (1) intervention or (2) standard care. A total of 314 participants will be recruited into the study. The intervention will include a pharmacist-partnered opioid tapering programme in which a pharmacist will work with participants to reduce their opioid dose over a 3-month period before surgery. Standard care will involve review by the hospital preadmission clinic multidisciplinary team to assess medical, physical and psychological health prior to surgery and education sessions for preoperative and postoperative care. The primary outcome assessed is persistent opioid use 3 months post surgery. The key secondary outcome is total Western Ontario and McMaster Universities Arthritis Index score. Data analysis will be performed using an estimand framework, with a generalised estimating equation model for the primary outcome from 1 day to 3 days presurgery to 3 months post surgery and a multilevel model for the main secondary outcome from baseline to 3 months after surgery. Cost-effectiveness and cost-utility analyses will be conducted to determine whether the intervention is cost-effective from the healthcare system perspective.

Ethics and dissemination

Ethics approval for this study was granted by a Human Research Ethics Committee (approval number: 2023/ETH01042). Results will be disseminated in peer reviewed journals, at international scientific meetings as well as meetings with key stakeholders and via the media.

Trial registration number

ACTRN12623000685617.

N-terminal proBNP adds prognostic value to high-sensitivity cardiac troponin I in elective thoracic surgery: an observational cohort study

Por: Alonso · M. · Popova · E. · De Miguel · M. · Garcia-Osuna · A. · Gonzalez-Tallada · A. · Ordonez-Llanos · J. · Jauregui · A. · Trujillo · J. C. · Martin Grande · A. · Martinez-Tellez · E. · Parera · A. · Planas · G. · Trujillo · L. · Butron · D. · Sola-Roca · J. · De Nadal · M.
Background

Perioperative myocardial injury (PMI) is a common complication following non-cardiac, particularly thoracic, surgery and is associated with increased cardiovascular risk. Although guidelines recommend cardiac biomarker monitoring to detect PMI, its implementation in routine clinical practice remains limited.

Objective

To evaluate the combined use of high-sensitivity cardiac troponin I (hs-cTnI) and N-terminal pro-brain natriuretic peptide (NT-proBNP) in predicting major adverse cardiovascular events (MACE) following elective thoracic surgery, and to determine whether NT-proBNP provides incremental prognostic value beyond hs-cTnI alone.

Design

Multicentre observational cohort study.

Setting

Conducted between February 2021 and November 2023 in three Spanish tertiary hospitals.

Participants

Patients aged ≥45 years scheduled for elective thoracic surgery involving lung resection (pneumonectomy, lobectomy, bilobectomy or segmentectomy) under general anaesthesia. Exclusion criteria included urgent or non-thoracic surgery, active infection or sepsis and a history of severe heart failure (ejection fraction

Main outcome measures

Combined measurement of hs-cTnI and NT-proBNP at baseline (preoperatively) and at 24 and 48 hours postoperatively.

PMI was defined as hs-cTnI ≥45 ng/L at 24 and/or 48 hours or a ≥20% increase from baseline in patients with elevated preoperative concentrations.

Results

Among 475 patients, PMI occurred in 11.8%. PMI had higher rates of prior stroke (12.5% vs 2.9%; p=0.004), smoking history (85.7% vs 64.0%; p=0.001) and severe renal dysfunction (7.1% vs 0.7%; p=0.001), with similar Revised Cardiac Risk Index distribution. Patients with PMI also had greater postoperative elevations of hs-cTnI and NT-proBNP (p

Conclusions

Combined hs-cTnI and NT-proBNP assessment improves perioperative cardiovascular risk stratification beyond ischaemia.

Trial registration number

NCT04749212

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