INTRODUCTION:In March 2025, the Medicines and Healthcare products Regulatory Agency published a drug safety update removing the indication of postoperative pain from the licence of prolonged-release opioids and mandated discussing risks with patients. Our study assessed compliance with these recommendations 6 months post-publication. METHODS:A cross-sectional survey on organisational discharge opioid prescribing practices was distributed via the National Confidential Enquiry into Patient Outcome and Death Local Reporter pathway to acute hospitals in England, Wales and Northern Ireland. Surveys targeted Day Surgery Unit managers and Drugs and Therapeutics Committee secretaries. RESULTS:We received responses from 83 Day Surgery Units and 70 Drug and Therapeutics Committees (approximately 68% response rate). Before March 2025, 51/70 (73%) Trusts routinely used modified-release opioids. Following the drug safety update, 59/70 (84%) committees shared the guidance and, consequently, 38/51 (75%) organisations that previously used modified-release opioids no longer do so. However, 10/70 (14%) units still dispensed modified-release opioids. Among day surgery units dispensing opioids, only 19/60 (32%) provided discharge letters that advised general practitioners against repeat prescriptions and 17/60 (28%) units provided patient information on opioid risks. Formal training on acute postoperative pain management was confirmed for only 22/83 (27%) responding units. DISCUSSION:Six months after the drug safety update, there is evidence of significant impact, with most Trusts sharing the alert and moving away from modified-release opioids. However, substantial work is still required. Key gaps include continued dispensing of modified-release and combination opioids, and poor communication with patients and general practitioners regarding opioid risks and safe disposal.
SummaryIntroductionGlucagon‐like peptide‐1 receptor agonists, dual glucose‐dependent insulinotropic peptide receptor agonists and sodium‐glucose cotransporter‐2 inhibitors are used increasingly in patients receiving peri‐operative care. These drugs may be associated with risks of peri‐operative pulmonary aspiration or euglycaemic ketoacidosis. We produced a consensus statement for the peri‐operative management of adults taking these drugs.MethodsThis multidisciplinary consensus statement included surgeons, anaesthetists, physicians, pharmacists and people with lived experience relevant to these guidelines. Following the directed literature review, a three‐round modified Delphi process was conducted to generate and ratify recommendations.ResultsPatients taking glucagon‐like peptide‐1 receptor agonists and dual glucose‐dependent insulinotropic peptide receptor agonists should: continue these drugs before surgery; have full risk assessment and stratification; and receive peri‐operative techniques that may mitigate risk of pulmonary aspiration before, during and after sedation or general anaesthesia. Patients taking sodium‐glucose cotransporter‐2 inhibitors should omit them the day before and the day of a procedure. All patients should have risks and mitigation strategies discussed with a shared decision‐making approach.DiscussionUntil more evidence becomes available, this pragmatic, multidisciplinary consensus statement aims to support shared decision‐making and improve safety for patients taking glucagon‐like peptide‐1 receptor agonists, dual glucose‐dependent insulinotropic peptide receptor agonists and sodium‐glucose cotransporter‐2 inhibitors during the peri‐operative period.
Diabetes mellitus is the most common endocrine disorder affecting surgical patients; although it occurs in 10% of the general population it is seen in up to 25% of the surgical population. Historically, patients with diabetes undergoing surgery were deemed to be very high risk and were often denied the benefits of day surgery. The application of the integrated care pathway coupled with perioperative manipulation of patients’ drugs has transformed surgical care for people with diabetes. Despite these advances, harm from dysglycaemia is not infrequent. The challenge facing clinicians and patients is to further mitigate the harm from hypo- and hyperglycaemia.
Type 2 diabetes mellitus is an increasingly common long-term condition, and suboptimal perioperative glycaemic control can lead to postoperative harms. The advent of new antidiabetic drugs, in particular glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose cotransporter 2 (SGLT2) inhibitors, has enabled perioperative continuation of these medicines, thus avoiding the harms of variable rate i.v. insulin infusions whilst providing glycaemic control. There are differences between medicines regulatory agencies and organisations on how these classes that are most often used to treat diabetes mellitus, (but also in the case of SGLT2 inhibitors chronic kidney disease and heart failure in those without diabetes) should be managed in the perioperative period. In this commentary, we argue that GLP-1 receptor agonists should continue during the perioperative period and that SGLT2 inhibitors should only be omitted the day prior to a planned procedure . The reasons for the differing advice advocated between regulatory agencies and what anaesthetic practitioners should do in the face of continuing uncertainty are discussed.
Background Nearly half of adult patients undergoing surgery experience moderate or severe postoperative pain. Inadequate pain management hampers postoperative recovery and function and may be associated with adverse outcomes. This multidisciplinary consensus statement provides principles that might aid postoperative recovery, and which should be applied throughout the entire peri-operative pathway by healthcare professionals, institutions and patients. Methods We conducted a directed literature review followed by a four-round modified Delphi process to formulate recommendations for organisations and individuals. Results We make recommendations for the entire peri-operative period, covering pre-admission; admission; intra-operative; post-anaesthetic care unit; ward; intensive care unit; preparation for discharge; and post-discharge phases of care. We also provide generic principles of peri-operative pain management that clinicians should consider throughout the peri-operative pathway, including: assessing pain to facilitate function; use of multimodal analgesia, including regional anaesthesia; non-pharmacological strategies; safe use of opioids; and use of protocols and training for staff in caring for patients with postoperative pain. Conclusions We hope that with attention to these principles and their implementation, outcomes for adult patients having surgery might be improved.
Summary Modified‐release opioids are often prescribed for the management of moderate to severe acute pain following total hip and knee arthroplasty, despite recommendations against their use due to increasing concerns regarding harm. The primary objective of this multicentre study was to examine the impact of modified‐release opioid use on the incidence of opioid‐related adverse events compared with immediate‐release opioid use, among adult inpatients following total hip or knee arthroplasty. Data for total hip and knee arthroplasty inpatients receiving an opioid analgesic for postoperative analgesia during hospitalisation were collected from electronic medical records of three tertiary metropolitan hospitals in Australia. The primary outcome was the incidence of opioid‐related adverse events during hospital admission. Patients who received modified with or without immediate‐release opioids were matched to those receiving immediate‐release opioids only (1:1) using nearest neighbour propensity score matching with patient and clinical characteristics as covariates. This included total opioid dose received. In the matched cohorts, patients given modified‐release opioids (n = 347) experienced a higher incidence of opioid‐related adverse events overall, compared with those given immediate‐release opioids only (20.5%, 71/347 vs. 12.7%, 44/347; difference in proportions 7.8% [95%CI 2.3–13.3%]). Modified‐release opioid use was associated with an increased risk of harm when used for acute pain during hospitalisation after total hip or knee arthroplasty.
Summary Prescription of modified‐release opioids for acute postoperative pain is widespread despite evidence to show their use may be associated with an increased risk of adverse effects. This systematic review and meta‐analysis aimed to examine the available evidence on the safety and efficacy of modified‐release, compared with immediate‐release, oral opioids for postoperative pain in adults. We searched five electronic databases from 1 January 2003 to 1 January 2023. Published randomised clinical trials and observational studies on adults who underwent surgery which compared those who received oral modified‐release opioids postoperatively with those receiving oral immediate‐release opioids were included. Two reviewers independently extracted data on the primary outcomes of safety (incidence of adverse events) and efficacy (pain intensity, analgesic and opioid use, and physical function) and secondary outcomes (length of hospital stay, hospital readmission, psychological function, costs, and quality of life) up to 12 months postoperatively. Of the eight articles included, five were randomised clinical trials and three were observational studies. The overall quality of evidence was low. Modified‐release opioid use was associated with a higher incidence of adverse events (n = 645, odds ratio (95%CI) 2.76 (1.52–5.04)) and worse pain (n = 550, standardised mean difference (95%CI) 0.2 (0.04–0.37)) compared with immediate‐release opioid use following surgery. Our narrative synthesis concluded that modified‐release opioids showed no superiority over immediate‐release opioids for analgesic consumption, length of hospital stay, hospital readmissions or physical function after surgery. One study showed that modified‐release opioid use is associated with higher rates of persistent postoperative opioid use compared with immediate‐release opioid use. None of the included studies reported on psychological function, costs or quality of life.
By reading this article you should be able to: •Identify the key organisational components of 'opioid stewardship' programmes. •Identify key risk factors for persistent opioid use, opioid-induced ventilatory impairment and opioid diversion. •Develop effective written and verbal information for patients and caregivers on the safe use of opioids after discharge from hospital. •Describe the pharmacological properties of the ideal opioid to be prescribed at the time of discharge. Anna Simpson BA(Hons) PhD FRCA is a specialty registrar in anaesthesia in the Severn Deanery, UK. Nicholas Levy FRCA BSc is a consultant in anaesthesia and acute pain at West Suffolk Hospital. His major research interests are reducing harms from perioperative opioid use. He led the International multidisciplinary consensus statement on the prevention of opioid-related harm in the adult surgical patient. Edward R Mariano MD MAS FASA is professor and senior vice chair, Department of Anesthesiology, Perioperative and Pain Medicine at Stanford University School of Medicine, and chief of Anesthesiology and Perioperative Care, Veterans Affairs Palo Alto Health Care System. He has served as a director of the American Society of Regional Anesthesia and Pain Medicine and has chaired the American Society of Anesthesiologists' Pain Summit projects.
We read with interest the study by Lam et al. [1]. This was a retrospective cohort study conducted in four large private hospitals in Australia comparing persistent postoperative opioid use (defined as a current prescription at 90 days following hospital discharge) in surgical patients prescribed immediate release, or modified formulations, of either oxycodone or tapentadol on hospital discharge. Oxycodone is a synthetic opioid with a well-documented role in contributing to the global opioid crisis, whilst tapentadol is a newer ‘atypical’ drug. It is noteworthy that Seqirus Pty Ltd. funded the study and is also the manufacturer of tapentadol. Lam et al. included 120,000 patients in their analysis. They demonstrated the following: the risk of persistent postoperative opioid use was lowest in opioid-naïve patients prescribed immediate release opioid rather than modified-release opioids, “For opioid-naive patients receiving immediate-release opioids, there was no significant effect of opioid type”, and that both modified-release tapentadol and oxycodone were associated with more persistent postoperative opioid use than immediate-release preparations of the two opioids; however, modified-release oxycodone was marginally more associated with persistent postoperative opioid use than modified-release tapentadol. We, therefore, argue that the conclusion that there “appeared to be lower odds of persistence for tapentadol compared with oxycodone among key subgroups” is misleading. The lower odds of persistence of opioid use only occurred when modified-release tapentadol was compared with modified-release oxycodone, and was not statistically significant when comparing immediate-release formulations. This distinction is important as the use of postoperative modified-release opioids is no longer recommended by many worldwide societies due to the risk of persistent postoperative opioid use and opioid-induced ventilatory impairment [1-5]. Indeed, the findings add to the body of evidence that the use of modified-release opioids is a significant driver for persistent postoperative opioid use, and that surgical patients should only receive immediate-release formulations of opioids. The study does, however, demonstrate that patients taking modified-release oxycodone have the highest risk of persistent postoperative opioid use. This is unsurprising as modified-release oxycodone is the archetypal opioid that caused the opioid epidemic. Like all modified-release opioids, modified-release oxycodone is difficult for patients to wean from, but the intrinsic likeability of oxycodone, as well as the short duration of action of modified-release oxycodone, further increases the risk of persistent postoperative opioid use [2-4] (Table 1). Inability to titrate down as pain recedes. False assumption that postoperative pain has a flat trajectory, until opioids are no longer required. Increase complexity of postoperative opioid weaning and deprescribing Biphasic release causing a peak and trough. Duration of action is only approximately 7 h in many patients Persistent post-surgical opioid use is not without risks. It is associated with increased risk of death from opioid-induced ventilatory impairment and increased risk of harm from other opioid-related adverse drug events, including susceptibility to infection; falls and trauma; failed operations; opioid-induced hyperalgesia; and chronic pain states [5]. The knowledge base against the utilisation of postoperative prescription of modified-release opioids on hospital discharge is now overwhelming; the use of modified-release opioids is associated with worse pain control, higher opioid consumption, as well as harms from higher rates of persistent postoperative opioids use and opioid-induced ventilatory impairment [1-5]. Consequently several regulatory and national bodies, including the US Food and Drug Administration, the US Centers for Disease Control and Prevention, Australia's Faculty of Pain Medicine and Australia's Therapeutic Goods Administration now advise against the use of modified-release opioids, except for long-term treatment of pain [2-5]. In a similar manner, and with the intention of reducing the risk of inadvertent persistent postoperative opioid use and opioid-induced ventilatory impairment, other regulatory bodies, including the Medicines and Healthcare products Regulatory Agency in the UK, must review the literature and make recommendations on the use of modified-release opioid preparations for the management of self-limiting acute pain.
AnaesthesiaVolume 78, Issue 9 p. 1062-1066 Editorial The prescribed opioid crisis as an impetus to improve postoperative pain management A. Simpson, A. Simpson Specialty Trainee orcid.org/0009-0001-3870-5095 @drannaksimpson Department of Anaesthesia, Bristol Royal Infirmary, University Hospitals Bristol and Weston, Bristol, UKSearch for more papers by this authorE. Keane, E. Keane Specialist Registrar @eimearkeane_ Department of Anaesthesia and Critical Care Medicine, Children's Hospital Ireland at Temple Street, Dublin, IrelandSearch for more papers by this authorN. Levy, Corresponding Author N. Levy Consultant [email protected] orcid.org/0000-0002-2225-1535 @nicholasalevy Department of Anaesthesia and Peri-operative Medicine, West Suffolk NHS Foundation Trust, Bury St Edmunds, Suffolk, UK Correspondence to: N. Levy Email: [email protected]Search for more papers by this author A. Simpson, A. Simpson Specialty Trainee orcid.org/0009-0001-3870-5095 @drannaksimpson Department of Anaesthesia, Bristol Royal Infirmary, University Hospitals Bristol and Weston, Bristol, UKSearch for more papers by this authorE. Keane, E. Keane Specialist Registrar @eimearkeane_ Department of Anaesthesia and Critical Care Medicine, Children's Hospital Ireland at Temple Street, Dublin, IrelandSearch for more papers by this authorN. Levy, Corresponding Author N. Levy Consultant [email protected] orcid.org/0000-0002-2225-1535 @nicholasalevy Department of Anaesthesia and Peri-operative Medicine, West Suffolk NHS Foundation Trust, Bury St Edmunds, Suffolk, UK Correspondence to: N. Levy Email: [email protected]Search for more papers by this author First published: 14 June 2023 https://doi.org/10.1111/anae.16054 1 Specialty Trainee, Department of Anaesthesia, Bristol Royal Infirmary, University Hospitals Bristol and Weston, Bristol, UK 2 Specialist Registrar, Department of Anaesthesia and Critical Care Medicine, Children's Hospital Ireland at Temple Street, Dublin, Ireland 3 Consultant, Department of Anaesthesia and Peri-operative Medicine, West Suffolk NHS Foundation Trust, Bury St Edmunds, Suffolk, UK This editorial accompanies an article by Baamer et al., Anaesthesia 2023; 78: 1081–92. Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat References 1Kharasch ED, Clark JD, Adams JM. Opioids and public health: the prescription opioid ecosystem and need for improved management. Anesthesiology 2022; 136: 10–30. 2Degenhardt L, Grebely J, Stone J, et al. Global patterns of opioid use and dependence: harms to populations, interventions, and future action. Lancet 2019; 394: 1560–79. 3Levy N, Quinlan J, El-Boghdadly K, et al. An international multidisciplinary consensus statement on the prevention of opioid-related harm in adult surgical patients. Anaesthesia 2021; 76: 520–36. 4Shah A, Hayes CJ, Martin BC. Characteristics of initial prescription episodes and likelihood of long-term opioid use—United States, 2006–2015. Morbidity and Mortality Weekly Report 2017; 66: 265–9. 5Kluger MT, Rice DA, Borotkanics R, et al. Factors associated with persistent opioid use 6–12 months after primary total knee arthroplasty. Anaesthesia 2022; 77: 882–91. 6Lam T, Xia T, Biggs N, et al. Effect of discharge opioid on persistent postoperative opioid use: a retrospective cohort study comparing tapentadol with oxycodone. Anaesthesia 2023; 78: 420–31. 7Jani M, Birlie Yimer B, Sheppard T, Lunt M, Dixon WG. Time trends and prescribing patterns of opioid drugs in UK primary care patients with non-cancer pain: a retrospective cohort study. 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Perioperative Quality Improvement Report 3: August 2019–July 2021. 2021 https://pqip.org.uk/FilesUploaded/PQIP-Annual-Report_2021.pdf (accessed 09/05/2023). 13Levy N, Mills P, Rockett M. Post-surgical pain management: time for a paradigm shift. British Journal of Anaesthesia 2019; 123: E182–6. 14Hyland SJ, Brockhaus KK, Vincent WR, Spence NZ, Lucki MM, Howkins MJ, Cleary RK. Perioperative pain management and opioid stewardship: a practical guide. Healthcare 2021; 9: 333. 15Larach DB, Hah JM, Brummett CM. Perioperative opioids, the opioid crisis, and the anesthesiologist. Anesthesiology 2022; 136: 594–608. 16Roberts GP, Levy N, Lobo DN. Patient-centric goal-oriented preoperative care. British Journal of Anaesthesia 2021; 126: 559–64. 17Baamer RM, Iqbal A, Lobo DN, Knaggs RD, Levy NA, Toh LS. Utility of unidimensional and functional pain assessment tools in adult postoperative patients: a systematic review. 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Epidural vs. transversus abdominis plane block for abdominal surgery–a systematic review, meta-analysis and trial sequential analysis. Anaesthesia 2021; 76: 101–17. 22Mariano ER, Dickerson DM, Szokol JW, et al. A multi-society organizational consensus process to define guiding principles for acute perioperative pain management. Regional Anesthesia and Pain Medicine 2022; 47: 118–27. 23Bickett MC, Brummett CM, Mariano ER. Tapentadol and the opioid epidemic: a simple solution or short-lived sensation? Anaesthesia 2023; 78: 416–9. 24Kehlet H. Enhanced postoperative recovery: good from afar, but far from good? Anaesthesia 2020; 75: e54–61. 25Levy N, McNally SA, Lobo DN. The need to improve opioid prescribing and data collection in patients undergoing orthopaedic surgery. Anaesthesia 2022; 77: 854–7. 26Aglio LS, Mezzalira E, Mendez-Pino L, et al. Surgical prehabilitation: strategies and psychological intervention to reduce postoperative pain and opioid use. 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Modified-release opioid tablets were introduced into surgical practice in the belief that they provided superior pain relief and reduced nursing workload, and they rapidly became embedded into many perioperative pathways. Although national and international guidelines for the management of postoperative pain now advise against the use of modified-release opioids, they continue to be prescribed in many centres. Recognition that modified-release opioids show lack of benefit and increased risk of harm compared with immediate-release opioids in the acute, postoperative setting has become clear. Their slow onset and offset make rapid and safe titration of these opioids impossible, including down-titration as the patient recovers; pain relief may be less effective; they have been associated with an increased incidence of opioid-related adverse drug events, increased length of hospital stay, and higher readmission rates; and they lead to higher rates of opioid-induced ventilatory impairment and persistent postoperative opioid use. Evidence indicates that modified-release opioids should not be used routinely in the postoperative period.
1Consultant, Department of Anaesthesia and Peri-operativeMedicine,West Suffolk NHS Foundation Trust, Bury St Edmunds, Suffolk, UK 2Consultant, Department of Trauma andOrthopaedics, East Sussex HealthcareNHS Trust, Eastbourne, Sussex, UK 3Honorary Clinical Professor, Brighton and SussexMedical School, Brighton, UK 4 Professor, NottinghamDigestiveDiseases Centre andNational Institute for Health ResearchNottinghamBiomedical ResearchCentre, NottinghamUniversity Hospitals andUniversity of Nottingham,Nottingham, UK 5Clinical Director, DavidGreenfieldMetabolic Physiology Unit,MRCVersus Arthritis Centre forMusculoskeletal Ageing Research, School of Life Sciences, University of Nottingham,Queen’sMedical Centre, Nottingham, UK
Importance Uncontrolled and indiscriminate prescribing of opioids has led to an opioid crisis that started in North America and spread throughout high-income countries. The aim of this narrative review was to explore some of the current issues surrounding the use of opioids in the perioperative period, focusing on drivers that led to escalation of use, patient harms, the move away from using self-reported pain scores alone to assess adequacy of analgesia, concerns about the routine use of controlled-release opioids for the management of acute pain, opioid-free anesthesia and analgesia, and prescription of opioids on discharge from hospital. Observations The origins of the opioid crisis are multifactorial and may include good intentions to keep patients pain free in the postoperative period. Assessment of patient function may be better than unidimensional numerical pain scores to help guide postoperative analgesia. Immediate-release opioids can be titrated more easily to match analgesic requirements. There is currently no good evidence to show that opioid-free anesthesia and analgesia affects opioid prescribing practices or the risk of persistent postoperative opioid use. Attention should be paid to discharge opioid prescribing as repeat and refill prescriptions are risk-factors for persistent postoperative opioid use. Opioid stewardship is paramount, and many governments are passing legislation, while statutory bodies and professional societies are providing advice and guidance to help mitigate the harm caused by opioids. Conclusions and Relevance Opioids remain a crucial part of many patients’ journey from surgery to full recovery. The last few decades have shown that unfettered opioid use puts patients and societies at risk, so caution is needed to mitigate those dangers. Opioid stewardship provides a multilayered structure to allow continued safe use of opioids as part of broad pain management strategies for those patients who benefit from them most.
Objectives To examine whether the use of process mapping and a multidisciplinary Delphi can identify potential contributors to perioperative risk. We hypothesised that this approach may identify factors not represented in common perioperative risk tools and give insights of use to future research in this area.Design Multidisciplinary, modified Delphi study.Setting Two centres (one tertiary, one secondary) in the UK during 2020 amidst coronavirus pressures.Participants 91 stakeholders from 23 professional groups involved in the perioperative care of older patients. Key stakeholder groups were identified via process mapping of local perioperative care pathways.Results Response rate ranged from 51% in round 1 to 19% in round 3. After round 1, free text suggestions from the panel were combined with variables identified from perioperative risk scores. This yielded a total of 410 variables that were voted on in subsequent rounds. Including new suggestions from round two, 468/519 (90%) of the statements presented to the panel reached a consensus decision by the end of round 3. Identified risk factors included patient-level factors (such as ethnicity and socioeconomic status), and organisational or process factors related to the individual hospital (such as policies, staffing and organisational culture). 66/160 (41%) of the new suggestions did not feature in systematic reviews of perioperative risk scores or key process indicators. No factor categorised as ‘organisational’ is currently present in any perioperative risk score.Conclusions Through process mapping and a modified Delphi we gained insights into additional factors that may contribute to perioperative risk. Many were absent from currently used risk stratification scores. These results enable an appreciation of the contextual limitations of currently used risk tools and could support future research into the generation of more holistic data sets for the development of perioperative risk assessment tools.