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Hepatopancreaticobiliary Resection Arginine Immunomodulation (PRIMe) trial: protocol for a randomised phase II trial of the impact of perioperative immunomodulation on immune function following resection for hepatopancreaticobiliary malignancy

Por: Behman · R. · Auer · R. C. · Bubis · L. · Xu · G. · Coburn · N. G. · Martel · G. · Hallet · J. · Balaa · F. · Law · C. · Bertens · K. A. · Abou Khalil · J. · Karanicolas · P. J.
Introduction

Surgical stress results in immune dysfunction, predisposing patients to infections in the postoperative period and potentially increasing the risk of cancer recurrence. Perioperative immunonutrition with arginine-enhanced diets has been found to potentially improve short-term and cancer outcomes. This study seeks to measure the impact of perioperative immunomodulation on biomarkers of the immune response and perioperative outcomes following hepatopancreaticobiliary surgery.

Methods and analysis

This is a 1:1:1 randomised, controlled and blinded superiority trial of 45 patients. Baseline and perioperative variables were collected to evaluate immune function, clinical outcomes and feasibility outcomes. The primary outcome is a reduction in natural killer cell killing as measured on postoperative day 1 compared with baseline between the control and experimental cohorts.

Ethics and dissemination

This trial has been approved by the research ethics boards at participating sites and Health Canada (parent control number: 223646). Results will be distributed widely through local and international meetings, presentation, publication and ClinicalTrials.gov (identifier: NCT04549662). Any modifications to the protocol will be communicated via publications and ClinicalTrials.gov.

Trial registration number

ClinicalTrials.gov identifier: NCT04549662.

The current state of knowledge on care for co‐occurring chronic pain and opioid use disorder: A scoping review

Abstract

Background and Aims

Opioid use disorder often co-occurs with chronic pain but assessment and treatment of these co-occurring disorders is complex. This review aims to identify current treatments and delivery models for co-occurring chronic pain and opioid use disorder (OUD) documented in the scientific literature.

Design

Scoping review.

Methods

The review was conducted in six databases in June 2022 (no time limit): CINAHL, PsycINFO, Web of Science, Cochrane, PubMed and Embase. The PRISMA-ScR checklist was used to guide reporting.

Results

Forty-seven publications addressing the issue of co-occurring chronic pain and OUD management were included. Randomized controlled trials provide evidence for the effectiveness of opioid agonist treatments (OAT) such as methadone or buprenorphine/naloxone, as well as for combining OAT with Mindfulness-Oriented Recovery Enhancement or cognitive behavioural therapy. A number of other pharmacological treatments (opioid and nonopioid), nonpharmacological treatments (e.g. physiotherapy) and service delivery models (e.g. simultaneous treatment of comorbidities, interdisciplinary and interprofessional collaboration) are also underlined. In most cases, authors recommend a combination of strategies to meet patient needs.

Conclusions

The scoping review reveals gaps in evidence-based knowledge to effectively care for co-occurring chronic pain and OUD, but several experts recommend the uptake of known ‘best’ practices such as integrated treatment of the multiple biopsychosocial dimensions of the co-occurring disorders as well as collaborative interdisciplinary work.

Clinical Relevance

Improving services is dependent on alleviating barriers such as working in silos, the costs associated with nonpharmacological treatments, and the double stigma associated with pain in people with a substance use disorder.

Effectiveness of dexmedetomidine during surgery under general anaesthesia on patient-centred outcomes: a systematic review and Bayesian meta-analysis protocol

Por: Verret · M. · Le · J. B. P. · Lalu · M. M. · McIsaac · D. I. · Nicholls · S. · Turgeon · A. F. · Hutton · B. · Zivkovic · F. · Graham · M. · Le · M. · Geist · A. · Berube · M. · Gilron · I. · Poulin · P. · Daudt · H. · Martel · G. · McVicar · J. · Moloo · H. · Fergusson · D. A.
Introduction

Dexmedetomidine is a promising pharmaceutical strategy to minimise opioid use during surgery. Despite its growing use, it is uncertain whether dexmedetomidine can improve patient-centred outcomes such as quality of recovery and pain.

Methods and analysis

We will conduct a systematic review and meta-analysis following the recommendations of the Cochrane Handbook for Systematic Reviews. We will search MEDLINE, Embase, CENTRAL, Web of Science and CINAHL approximately in October 2023. We will include randomised controlled trials evaluating the impact of systemic intraoperative dexmedetomidine on patient-centred outcomes. Patient-centred outcome definition will be based on the consensus definition established by the Standardised Endpoints in Perioperative Medicine initiative (StEP-COMPAC). Our primary outcome will be the quality of recovery after surgery. Our secondary outcomes will be patient well-being, function, health-related quality of life, life impact, multidimensional assessment of postoperative acute pain, chronic pain, persistent postoperative opioid use, opioid-related adverse events, hospital length of stay and adverse events. Two reviewers will independently screen and identify trials and extract data. We will evaluate the risk of bias of trials using the Cochrane Risk of Bias Tool (RoB 2.0). We will synthesise data using a random effects Bayesian model framework, estimating the probability of achieving a benefit and its clinical significance. We will assess statistical heterogeneity with the tau-squared and explore sources of heterogeneity with meta-regression. We have involved patient partners, clinicians, methodologists, and key partner organisations in the development of this protocol, and we plan to continue this collaboration throughout all phases of this systematic review.

Ethics and dissemination

Our systematic review does not require research ethics approval. It will help inform current clinical practice guidelines and guide development of future randomised controlled trials. The results will be disseminated in open-access peer-reviewed journals, presented at conferences and shared among collaborators and networks.

PROSPERO registration number

CRD42023439896.

Point-of-care haemoglobin accuracy and transfusion outcomes in non-cardiac surgery at a Canadian tertiary academic hospital: protocol for the PREMISE observational study

Por: Brousseau · K. · Monette · L. · McIsaac · D. I. · Workneh · A. · Tinmouth · A. · Shaw · J. · Ramsay · T. · Mallick · R. · Presseau · J. · Wherrett · C. · Carrier · F. M. · Fergusson · D. A. · Martel · G.
Introduction

Transfusions in surgery can be life-saving interventions, but inappropriate transfusions may lack clinical benefit and cause harm. Transfusion decision-making in surgery is complex and frequently informed by haemoglobin (Hgb) measurement in the operating room. Point-of-care testing for haemoglobin (POCT-Hgb) is increasingly relied on given its simplicity and rapid provision of results. POCT-Hgb devices lack adequate validation in the operative setting, particularly for Hgb values within the transfusion zone (60–100 g/L). This study aims to examine the accuracy of intraoperative POCT-Hgb instruments in non-cardiac surgery, and the association between POCT-Hgb measurements and transfusion decision-making.

Methods and analysis

PREMISE is an observational prospective method comparison study. Enrolment will occur when adult patients undergoing major non-cardiac surgery require POCT-Hgb, as determined by the treating team. Three concurrent POCT-Hgb results, considered as index tests, will be compared with a laboratory analysis of Hgb (lab-Hgb), considered the gold standard. Participants may have multiple POCT-Hgb measurements during surgery. The primary outcome is the difference in individual Hgb measurements between POCT-Hgb and lab-Hgb, primarily among measurements that are within the transfusion zone. Secondary outcomes include POCT-Hgb accuracy within the entire cohort, postoperative morbidity, mortality and transfusion rates. The sample size is 1750 POCT-Hgb measurements to obtain a minimum of 652 Hgb measurements

Ethics and dissemination

Institutional ethics approval has been obtained by the Ottawa Health Science Network—Research Ethics Board prior to initiating the study. Findings from this study will be published in peer-reviewed journals and presented at relevant scientific conferences. Social media will be leveraged to further disseminate the study results and engage with clinicians.

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