Anaesthetic Technique for Minor Lower Limb Amputation Surgery (ATLLAS)

NCT07244627 | Not Yet Recruiting

• 1 other identifier: 338872
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anesthesia; Amputation; Traumatic, Leg, Lower

Outcome Measures

Primary Outcomes (1)

• Morbidity following 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 Outcomes (1)

• Comparing emergency and elective outcomes

  30 days post amputation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Amputations due to trauma, neurological disease or chronic pain

Sponsors & Collaborators

• University Hospitals of North Midlands NHS Trust: lead

Study Sites (1)

University Hospital of North Midlands

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

Location

Related Publications (7)

• Yammine K, Hayek F, Assi C. A meta-analysis of mortality after minor amputation among patients with diabetes and/or peripheral vascular disease. J Vasc Surg. 2020 Dec;72(6):2197-2207. doi: 10.1016/j.jvs.2020.07.086. Epub 2020 Aug 21.

  PMID: 32835790 BACKGROUND

• Ahmad N, Thomas GN, Gill P, Chan C, Torella F. Lower limb amputation in England: prevalence, regional variation and relationship with revascularisation, deprivation and risk factors. A retrospective review of hospital data. J R Soc Med. 2014 Dec;107(12):483-9. doi: 10.1177/0141076814557301. Epub 2014 Nov 11.

  PMID: 25389229 BACKGROUND

• Chery J, Semaan E, Darji S, Briggs WT, Yarmush J, D'Ayala M. Impact of regional versus general anesthesia on the clinical outcomes of patients undergoing major lower extremity amputation. Ann Vasc Surg. 2014 Jul;28(5):1149-56. doi: 10.1016/j.avsg.2013.07.033. Epub 2013 Dec 14.

  PMID: 24342828 BACKGROUND

• Waton S, Johal A, Birmpili P et al. National Vascular Registry: 2022 Annual Report. London: The Royal College of Surgeons of England, November 2022

  BACKGROUND

• Khan SA, Qianyi RL, Liu C, Ng EL, Fook-Chong S, Tan MG. Effect of anaesthetic technique on mortality following major lower extremity amputation: a propensity score-matched observational study. Anaesthesia. 2013 Jun;68(6):612-20. doi: 10.1111/anae.12182. Epub 2013 Apr 1.

  PMID: 23550809 BACKGROUND

• Pisansky AJB, Brovman EY, Kuo C, Kaye AD, Urman RD. Perioperative Outcomes after Regional Versus General Anesthesia for Above the Knee Amputations. Ann Vasc Surg. 2018 Apr;48:53-66. doi: 10.1016/j.avsg.2017.10.014. Epub 2017 Dec 5.

  PMID: 29217448 BACKGROUND

• Walsh M, Lim S, Gill L, et al. Deleterious Effects of General Anesthesia on Minor Foot Amputations. Abstract from the 2018 Midwestern Vascular Surgical Society Annual Meeting, Journal of Vascular Surgery 2018; 68: E54-55

  BACKGROUND

Related Links

• Related Info

Central Study Contacts

Aviva Ogbolosingha

CONTACT

01782 675380; aviva.ogbolosingha@uhnm.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

GB (1)