Protocol for a prospective multicentre cohort study to address the question whether diabetes and its management is still a risk factor in fast-track joint arthroplasty.

INTRODUCTION: Perioperative glycaemic control is important. However, the complexity of guidelines for perioperative diabetes management is complicated due to different and novel antihyperglycaemic medications, limited procedure-specific data and lack of data from implemented fast-track regimens which otherwise are known to reduce morbidity and glucose homeostasis disturbances. Consequently, outcome in patients with diabetes mellitus (DM) after surgery and the influence of perioperative diabetes management on postoperative recovery remains poorly understood. METHODS AND ANALYSIS: A prospective observational multicentre study involving 8 arthroplasty centres across Denmark with a documented implemented fast-track programme (median length of hospitalisation (LOS) 1 day). We will collect detailed perioperative data including preoperative haemoglobin A1c and antidiabetic treatment in 1400 unselected consecutive patients with DM undergoing hip and knee arthroplasty from September 2022 to December 2025, enrolled after consent. Follow-up duration is 90 days after surgery. The primary outcome is the proportion of patients with DM with LOS >4 days and 90-day readmission rate after fast-track total hip arthroplasty (THA), total knee arthroplasty (TKA) and unicompartmental knee arthroplasty (UKA). The secondary outcome is the association between perioperative diabetes treatment and LOS >2 days, 90-day readmission rate, other patient demographics and Comprehensive Complication Index for patients with DM after THA/TKA/UKA in a fast-track regimen. ETHICS AND DISSEMINATION: The study will follow the principles of the Declaration of Helsinki and ICH-Good Clinical Practice guideline. Ethical approval was not necessary as this is a non-interventional observational study on current practice. The trial is registered in the Region of Southern Denmark and on ClinicalTrials.gov. The main results and all substudies of this trial will be published in peer-reviewed international medical journals. TRIAL REGISTRATION NUMBER: NCT05613439.

Challenges for perioperative glycaemic control in patients with diabetes.

In surgical patients, diabetes is associated with increased length of hospital stay and complications. Optimal glycaemic control is important to reduce complications, and enhanced recovery after surgery/fast-track protocols reduce the impact of surgery on glucose homeostasis. Guidelines for perioperative diabetes management are complex and not always supported by highest-grade evidence; this also includes guidelines for use of newer peroral antidiabetic drugs. Technology for automated insulin delivery based on continuous glucose monitoring is available and could potentially simplify and improve perioperative diabetic management, as argued in this review.

Participants with mild, moderate, or severe pain following total hip arthroplasty. A sub-study of the PANSAID trial on paracetamol and ibuprofen for postoperative pain treatment.

OBJECTIVES: In this sub-study of the 'Paracetamol and Ibuprofen in Combination' (PANSAID) trial, in which participants were randomised to one of four different non-opioids analgesic regimen consisting of paracetamol, ibuprofen, or a combination of the two after planned primary total hip arthroplasty, our aims were to investigate the distribution of participants' pain (mild, moderate or severe), integrate opioid use and pain to a single score (Silverman Integrated Approach (SIA)-score), and identify preoperative risk factors for severe pain. METHODS: We calculated the proportions of participants with mild (VAS 0-30 mm), moderate (VAS 31-60 mm) or severe (VAS 61-100 mm) pain and the SIA-scores (a sum of rank-based percentage differences from the mean rank in pain scores and opioid use, ranging from -200 to 200%). Using logistic regression with backwards elimination, we investigated the association between severe pain and easily obtainable preoperative patient characteristics. RESULTS: Among 556 participants from the modified intention-to-treat population, 33% (95% CI: 26-42) (Group Paracetamol + Ibuprofen (PCM + IBU)), 28% (95% CI: 21-37) (Group Paracetamol (PCM)), 23% (95% CI: 17-31) (Group Ibuprofen (IBU)), and 19% (95% CI: 13-27) (Group Half Strength-Paracetamol + Ibuprofen (HS-PCM + IBU)) experienced mild pain 6 h postoperatively during mobilisation. Median SIA-scores during mobilisation were: Group PCM + IBU: -48% (IQR: -112 to 31), Group PCM: 40% (IQR: -31 to 97), Group IBU: -5% (IQR: -57 to 67), and Group HS-PCM + IBU: 6% (IQR: -70 to 74) (overall difference: p=0.0001). Use of analgesics before surgery was the only covariate associated with severe pain (non-opioid: OR 0.50, 95% CI: 0.29-0.82, weak opioid 0.56, 95% CI: 0.28-1.16, reference no analgesics before surgery, p=0.02). CONCLUSIONS: Only one third of participants using paracetamol and ibuprofen experienced mild pain after total hip arthroplasty and even fewer experienced mild pain using each drug alone as basic non-opioid analgesic treatment. We were not able, in any clinically relevant way, to predict severe postoperative pain. A more extensive postoperative pain regimen than paracetamol, ibuprofen and opioids may be needed for a large proportion of patients having total hip arthroplasty. SIA-scores integrate pain scores and opioid use for the individual patient and may add valuable information in acute pain research.