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NCT Number: NCT07244627

Anaesthetic Technique for Minor Lower Limb Amputation Surgery (ATLLAS)

Major lower limb amputation is recognised as a significant cause of morbidity and mortality. In the United Kingdom, 30-day in-hospital mortality is up to 8.7%. Minor lower limb amputations, defined as amputation at or below the ankle, are often considered minor procedures, but mortality at one month is 3.5%, similar to that of below knee amputations and 20% at one year. Any amputation is an indicator of poor health and should be considered a pivotal event in a patient's healthcare journey. In England alone, 21,738 minor lower limb amputations were performed between 2017 and 2020, with annual procedures on an increasing trajectory. Recent work has demonstrated striking regional differences in rates of major lower limb amputations in England which the authors ascribed to inequalities in the provision of healthcare. Improving the regional provision of support services for amputees is also part of the current governments NHS Long Term Workforce Plan (https://lordslibrary.parliament.uk/access-to-prosthetics-for-amputees-in-england/).

While multiple studies have aimed to assess the impact of anaesthetic technique on outcomes following major lower limb amputation, there is little published data on factors impacting morbidity and mortality following minor lower limb amputation surgery. Evidence from the USA has shown deleterious effect of general anaesthesia (GA) as compared to regional anaesthesia for minor lower limb amputation in patients with peripheral artery disease. Higher rates of post-operative wound disruption, pneumonia, prolonged intubation, and septic shock were demonstrated with general anaesthesia rather than regional anaesthesia.

Investigators have performed a single centre retrospective review of 382 patients undergoing minor lower limb amputation for vascular disease in our Trust (UHNM). We found that our patients undergoing these procedures under peripheral nerve block (PNB) techniques were older with higher rates of heart and kidney disease than those receiving a general anaesthetic. Despite this, these patients had reduced complications and length of hospital stay than the fitter patients. The difference seen here became even more pronounced following propensity matching. Investigators demonstrated a clinically significant reduction in the respiratory complication rate of 5.3% and overall complication rate of 12% and a reduction in length of stay of 6 days following use of peripheral nerve blocks rather than general anaesthesia. Investigators also demonstrated a reduction in length of stay of 4 days when DARF Form v4 - July 2023 16 administering peripheral nerve blocks rather than neuraxial anaesthesia (NA). This small and monocentric study suggests that there is value in repeating this process in a larger, national dataset.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of North Midlands

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location contact

Aviva Ogbolosingha

CONTACT

[email protected]

01782 675380

Tim Scott

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (aged 18 and over).
  • National Vascular Registry data field - Procedure undertaken - amputation through ankle or below.
  • Procedure undertaken between 1st January 2019 and 1st January 2025.

Exclusion criteria

  • Amputations due to trauma, neurological disease or chronic pain

Treatment and study plan

Primary outcomes

  1. Morbidity following amputation

    Time frame: 30 days post amputation

    Compare all cause morbidity at 30 days following amputation under general, neuraxial and peripheral nerve block anaesthesia, converting it from local to national data

Secondary outcomes

  1. Comparing emergency and elective outcomes

    Time frame: 30 days post amputation

    Comparing emergency and elective outcomes against American society of Anaesthesiologists (ASA) grading. ASA classification uses a grading system of I (one) through V (five), with I identifying a person in good health and V as a person with a severe, life-threatening condition. The sixth (VI) status identifies deceased organ donors.

Study contacts

Contact information is provided by the study sponsor or research team.

Aviva Ogbolosingha

CONTACT

[email protected]

01782 675380

Sponsors and collaborators

Lead sponsor

University Hospitals of North Midlands NHS Trust

Other

Registry information

Official study title

Anaesthetic Technique for Minor Lower Limb Amputation Surgery (ATLLAS): A Retrospective Review of Outcomes

Acronym: ATLLAS

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Nov 24, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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