{
  "abstract": "Background Informed consent is a cornerstone of modern clinical practice, ensuring respect for patient autonomy. In regional anaesthesia, where procedures vary in complexity and timing, delivering valid consent necessitates balancing legal, ethical, and practical considerations. This abstract outlines key principles, synthesises recent UK/European guidance, and explores future approaches to optimising consent. Defining Informed Consent Consent is a dynamic process of information exchange and mutual understanding. According to the AMA, it involves communication between the patient and clinician leading to an authorised procedure. 1 The RCoA affirms that ‘valid consent is a process, not a one-off event’.2 Key elements include: • Disclosure of relevant risks, benefits, and alternatives. • Comprehension and opportunity for questions. • Voluntariness without coercion. • Capacity to make decisions. • Documentation of discussions and decisions. Current Guidelines RCoA’s Chapter 8: Guidelines for Regional Anaesthesia Services 2025 (May 2024) mandates local policies covering consent. Discussions must outline risks, benefits, and alternatives, including procedural sedation or general anaesthesia. Consent may be obtained on the day of surgery, if done early and away from the anaesthetic room. When regional anaesthesia is a standalone intervention (e.g. for rib fractures), written consent is advised.2 The Association of Anaesthetists of Great Britain and Ireland (AAGBI), in their 2017 guidelines, reaffirm that documentation of consent discussions is essential, including details of risks, benefits, alternatives, and the patient‘s questions and responses. However, they clarify that a separate, signed consent form is not required for anaesthetic procedures performed to facilitate surgery. In these instances, anaesthesia is considered part of an integrated treatment. Conversely, if regional anaesthesia is the primary intervention, such as in pain management, a signed consent form is recommended.3 These guidelines align with legal principles established in Montgomery, ensuring material risks are communicated based on what a reasonable person in the patient’s position would want to know.4ESAIC’s 2023 guidance promotes shared decision-making and context-specific disclosure. It moves beyond outdated paternalism to emphasise capacity, clarity, and autonomy. Despite these policies, implementation varies: an Australian audit reported just 28% compliance with documentation standards.5 Current Evidence and Practical Challenges McCombe and Bogod offer a comprehensive review of regional anaesthesia risks and consent, citing the legal precedent Montgomery v Lanarkshire (2015), which shifted consent standards toward what a reasonable patient would wish to know.6 They also outline GMC consent guidance and the Association of Anaesthetists’ view that anaesthesia may not always require standalone consent unless it is a primary intervention. Building upon the GMC guidance and the recognition of evolving legal expectations, Cook and Ainsworth argue that growing litigation involving consent justifies a re-evaluation of anaesthesia consent practices.7 Their editorial draws attention to the evolving medico-legal climate, where anaesthesia, traditionally seen as low-risk from a litigation standpoint, is increasingly implicated in claims involving inadequate consent. This shift forces the speciality to ask whether anaesthesia, like surgery, should involve a more formalised, standalone consent process. However, they also acknowledge the real-world tensions: elective surgical lists often run to tight schedules, making such thorough discussions challenging. They highlight the tension between thorough discussion and elective workflow pressures, a dilemma echoed by Chrimes and Marshall in their editorial ‘The Illusion of Informed Consent’.8 They argue that the expectations set by courts for what constitutes valid consent may be incompatible with the practical realities of anaesthetic care. Chrimes contends that if legal standards were applied strictly, patients might be overwhelmed by the sheer volume of information, leading to decision fatigue rather than empowerment. Zarnegar et al. demonstrated low patient recall of regional anaesthesia risks, a finding that underscores the ongoing challenge of delivering information in a manner that is both understandable and retainable for patients undergoing anaesthesia, reinforcing the need for clear, repeated communication.9 Rampersad et al. showed that a separate anaesthesia consent form improved patient understanding, albeit in a small cohort.10 The Legal Debate The evolution of informed consent law is exemplified by two landmark cases. In Rogers v Whitaker (1992), the High Court of Australia ruled in favour of a patient who became completely blind following eye surgery, emphasising that even rare risks must be disclosed if they are material to that particular patient.11 The patient, already blind in one eye, was not warned of the risk of sympathetic ophthalmia—a complication in the good eye—and the court found that the clinician had a duty to warn based on what a reasonable patient would want to know. In the UK, Montgomery v Lanarkshire Health Board (2015) reaffirmed this approach. The court ruled that doctors must take reasonable care to ensure patients are aware of material risks involved in any recommended treatment, as well as reasonable alternatives.4 Montgomery involved a diabetic woman of small stature who was not informed of the increased risk of shoulder dystocia during vaginal delivery. The court ruled that her autonomy to make an informed choice had been undermined. Together, these cases reshaped medical law to emphasise patient-centred consent. They pose critical questions for anaesthetists: What constitutes a material risk in regional anaesthesia? Should rare but serious risks—such as permanent nerve damage—be discussed routinely, and how should these be weighed against the patient‘s values and context? Improving Consent Delivery: Tools and Future Directions Evidence from systematic reviews supports multi-modal consent processes: • Digital tools (e.g. videos, apps) improved comprehension in 70% of studies without increasing anxiety.12 • Teach-back methods and multimedia formats enhance retention, especially in vulnerable populations.13 • Most written forms exceed ideal readability, limiting effectiveness.14 • Procedure-specific consent forms improve documentation but show mixed results in patient satisfaction and litigation impact.15 These studies highlight the need for tailored, layered consent using accessible formats, a principle that echoes the legal shift toward recognising patient-specific material risks, as outlined in the Rogers and Montgomery cases. Furthermore, they reinforce the ethical obligation of anaesthetists to ensure that patients comprehend key risks in a way that supports meaningful decision-making, thereby aligning legal, ethical, and clinical expectations. Conclusion Regional anaesthesia consent must be deliberate, flexible, and patient-focused. While guidelines exist, practice remains inconsistent. Innovations in education, consent tools, and institutional policies are essential to close the gap between policy and reality.References American Medical Association. Code of Medical Ethics: Opinion 2.1.1. 2024. Available at: https://code-medical-ethics.ama-assn.org/ethics-opinions/informed-consent. Accessed 20 Jun. 2025.RCoA. Chapter 8: Guidelines for Regional Anaesthesia Services 2025. Royal College of Anaesthetists. Published 13 May 2024.Yentis SM, Hartle AJ, Barker IR, et al. AAGBI: consent for anaesthesia 2017. Anaesthesia 2017;72(1):93–105. https://doi.org/10.1111/anae.13762. Accessed 20 Jun. 2025.Montgomery v Lanarkshire Health Board (2015) UKSC 11 (UK Supreme Court). Available at: https://www.supremecourt.uk/cases/docs/uksc-2013-0136-judgment.pdf. Accessed 20 Jun. 2025.De Silva YJ, Anderson L. Documentation of informed consent for anaesthesia: a single-site retrospective audit at a rural Australian hospital. Anaesth Intensive Care. 2024. https://doi.org/10.1177/0310057X2412813McCombe K, Bogod D. Regional anaesthesia: risk, consent and complications. Anaesthesia. 2021. Available at: https://associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.15246. Accessed 20 Jun. 2025.Ainsworth MJG, Cook TM. Pre-operative information, shared decision-making and consent for anaesthesia: time for a rethink. Anaesthesia 2023;78(10):1300–1303.Chrimes N, Marshall SD. The illusion of informed consent. Anaesthesia 2017. Available at: https://doi.org/10.1111/anae.14002. Accessed 20 Jun. 2025.Zarnegar R, Brown MRD, Henley M, Tidman V, Pathmanathan A. Patient perceptions and recall of consent for regional anaesthesia compared with consent for surgery. J R Soc Med. 2015;108(11):451–456. https://doi.org/10.1177/0141076815604494Rampersad K, Chen D, Hariharan S. Efficacy of a separate informed consent for anesthesia services: a prospective study from the caribbean. J Anaesthesiol Clin Pharmacol. 2016;32(1):18–24. https://doi.org/10.4103/0970-9185.173364Rogers v Whitaker (1992) 175 CLR 479 (High Court of Australia).Bollinger C, Saito H, Zhang K, et al. Digital technology in informed consent for surgery: a systematic review. BJS Open. 2023.Lee Y, Grant S, Kumar R. Interventions to improve patient comprehension in informed consent: an updated systematic review. BMJ Qual Saf. 2023.Martínez E, Gómez N, Ortega L. Readability of informed consent forms for medical and surgical procedures: a systematic review. Medicina 2024.Ahmed R, Davies J, Morgan P, Lewis T. Procedure-specific consent forms in clinical practice: a systematic review. Ann R Coll Surg Engl. 2024.",
  "authors": [
    {
      "affiliations": [
        "Specialist Anaesthesiology Registrar, SAT 3.5, Letterkenny University Hospital"
      ],
      "name": "Caroline Brogan"
    },
    {
      "affiliations": [
        "Consultant Anaesthesiology, Letterkenny, University Hospital"
      ],
      "name": "EML Moran"
    }
  ],
  "title": "FT44 Informed consent for regional anaesthesia: ethical foundations, practical challenges, and current guidance across Europe and the UK/Ireland",
  "uid": "a46fb66f-9534-5084-9d39-8c2bd898ed4a"
}