Anaesthetic Technique for Minor Lower Limb Amputation Surgery (ATLLAS) (ATLLAS)

December 3, 2025 updated by: University Hospitals of North Midlands NHS Trust

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Staffordshire
      • Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
        • University Hospital of North Midlands
        • Contact:
        • Principal Investigator:
          • Tim Scott

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients in the National Vascular Registry (NVR) database for minor lower limb amputations undertaken between January 2019 and January 2025.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days post amputation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days post amputation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals of North Midlands NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Estimated)

November 24, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 338872

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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