Haemodynamic Effects of Low-dose Spinal Anaesthesia for Hip Fracture Surgery.

NCT05799300 | Unknown

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

Brief Summary

Approximately 65, 000 hip fractures occur in the United Kingdom (UK) each year, and more than 99% are repaired by surgery. Roughly half of patients receive spinal anaesthesia, where a small amount (usually less than half a teaspoonful) of local anaesthetic is injected into the lower back, around the nerves that go to and from the hip. Low blood pressure is very common during surgery (at least \> 30%, depending on definition), and appears to be linked to a greater chance of death within a month after surgery. There are 2 main ways of managing low blood pressure during surgery: treatment and prevention. Treatments (fluids, drugs) have side effects in the older, frailer population with hip fracture. Prevention involves giving anaesthesia at lower doses. National guidelines recommend that lower doses are given, but this recommendation is based on historical research selectively involving younger, fitter people having hip fracture surgery. Importantly, these studies did not record blood pressure either accurately or often enough. The Anaesthesia Sprint Audit of Practice (ASAP) 2 study suggested that a safe level of low blood pressure occurs when only 1.5 mls of spinal anaesthesia is given, and the investigator has been using this amount in Brighton since 2011. Recently, the investigator has reported a way of transferring vital signs data from anaesthetic monitors to storage computers for medicolegal purposes (e.g. in Coroner's investigations: approximately 4000 people in the UK die annually within a month of hip fracture surgery). However, analyzing such observational data should also allow the investigator to describe accurately how blood pressure changes around the time of surgery, and in patient groups that are normally excluded from prospective research (e.g. the very old, the very frail, people with dementia). By comparing this data to published national data from the ASAP 1 study, the investigator hopes to determine whether lower doses of spinal anaesthesia are linked with a lower rate of low blood pressure during surgery, potentially improving people's survival and recovery after hip fracture.

Conditions

Hip Fractures

Keywords

Anaesthesia, spinal; Anaesthesia, cardiovascular effects; Surgery, hip fracture

Outcome Measures

Primary Outcomes (1)

• Cohort mean (SD) mean non-invasive blood pressure (MAP)

  Taken at 2 minute intervals peri-operatively for each patient

  Occurring during the 2 hour duration (approximately) of anaesthesia and surgery for each patient

Secondary Outcomes (5)

• The cohort prevalence of hypotension

  During anaesthesia and surgery

• Mean depth x duration area under curve product for cohort hypotension after low dose spinal anaesthesia for hip fracture surgery

  During anaesthesia and surgery

• Quantification of cohort systolic and mean arterial blood pressure changes before spinal administration

  During anaesthesia and surgery

• Effective cohort duration of spinal anaesthesia

  During anaesthesia and surgery

• Correlations between individual (a) hypotension (b) hypotension depth/duration product and outcomes (death at 30 days, length of stay in hospital)

  During anaesthesia and surgery

Study Arms (1)

Hip fracture cohort

Gender, Age, Racial and Ethnic Origin of Subjects Male and female adults over the age of 18 years; all origins, all races will be included. Inclusion/exclusion criteria as below

Procedure: Intrathecal anaesthesia

Interventions

Intrathecal anaesthesia PROCEDURE

Low dose 0.5% hyperbaric bupivacaine (1.3mls, 0.65mg) intrathecal anaesthesia.

Hip fracture cohort

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

People undergoing surgical hip fracture repair (hemiarthoplasty, dynamic hip screw, cortical screws, proximal femoral nail) administered spinal anaesthesia for whom contemporaneous vital signs (including blood pressure, heart rate, oxygen saturation, breathing rate) have been stored in an anonymised, double password-protected database held on secure computers at Princess Royal Hospital, Hayward's Heath (E. Sussex).

You may qualify if:

• Adults (over 18 years) who have sustained a unilateral hip fracture and received surgery (hemiarthroplasty, dynamic hip screw, cortical screws, proximal femoral nail) under low dose spinal anaesthesia (1.3 mls 0.5% hyperbaric bupivacaine) after fascia iliaca block + sedation, administered by the Chief Investigator (CI) between 3rd March, 2017 and 1st January, 2020 at the Princess Royal Hospital, Hayward's Heath (E Sussex).
• For whom crude vital signs data have been stored in pseudo-anonymised electronic form on secure hospital computers, for medico-legal reference

You may not qualify if:

• People with hip fracture receiving conservative management during the study period;
• People with hip fracture requiring total hip arthroplasty (for whom larger volumes of spinal anaesthesia are used);
• People with hip fracture administered spinal anaesthesia other than 1.3 mls 0.5% hyperbaric bupivacaine;

Sponsors & Collaborators

• Royal Sussex County Hospital: lead

Study Sites (1)

Royal Sussex County Hospital

Brighton, E Sussex, BN2 5BE, United Kingdom

Location

Related Publications (9)

• National Hip Fracture Database. 2019 Report. https://www.nhfd.co.uk/20/hipfractureR.nsf/docs/2019Report

  RESULT

• National Hip Fracture Database. Anaesthesia Sprint Audit of Practice (ASAP). 2014. https://www.nhfd.co.uk/20/hipfractureR.nsf/vwContent/asapReport/$file/onlineASAP.pdf

  RESULT

• White SM, Moppett IK, Griffiths R, Johansen A, Wakeman R, Boulton C, Plant F, Williams A, Pappenheim K, Majeed A, Currie CT, Grocott MP. Secondary analysis of outcomes after 11,085 hip fracture operations from the prospective UK Anaesthesia Sprint Audit of Practice (ASAP-2). Anaesthesia. 2016 May;71(5):506-14. doi: 10.1111/anae.13415. Epub 2016 Mar 4.

  PMID: 26940645 RESULT

• Griffiths R, Babu S, Dixon P, Freeman N, Hurford D, Kelleher E, Moppett I, Ray D, Sahota O, Shields M, White S. Guideline for the management of hip fractures 2020: Guideline by the Association of Anaesthetists. Anaesthesia. 2021 Feb;76(2):225-237. doi: 10.1111/anae.15291. Epub 2020 Dec 2.

  PMID: 33289066 RESULT

• Ben-David B, Frankel R, Arzumonov T, Marchevsky Y, Volpin G. Minidose bupivacaine-fentanyl spinal anesthesia for surgical repair of hip fracture in the aged. Anesthesiology. 2000 Jan;92(1):6-10. doi: 10.1097/00000542-200001000-00007.

  PMID: 10638892 RESULT

• Minville V, Fourcade O, Grousset D, Chassery C, Nguyen L, Asehnoune K, Colombani A, Goulmamine L, Samii K. Spinal anesthesia using single injection small-dose bupivacaine versus continuous catheter injection techniques for surgical repair of hip fracture in elderly patients. Anesth Analg. 2006 May;102(5):1559-63. doi: 10.1213/01.ane.0000218421.18723.cf.

  PMID: 16632842 RESULT

• White SM, Pateman J. A method of recording electronic anaesthetic monitor data for research. Anaesthesia. 2017 Feb;72(2):267-269. doi: 10.1111/anae.13794. No abstract available.

  PMID: 28093744 RESULT

• White SM, Rashid N, Chakladar A. An analysis of renal dysfunction in 1511 patients with fractured neck of femur: the implications for peri-operative analgesia. Anaesthesia. 2009 Oct;64(10):1061-5. doi: 10.1111/j.1365-2044.2009.06012.x.

  PMID: 19735395 RESULT

• White SM. A retrospective, observational, single-centre, cohort database analysis of the haemodynamic effects of low-dose spinal anaesthesia for hip fracture surgery. BJA Open. 2024 Feb 17;9:100261. doi: 10.1016/j.bjao.2024.100261. eCollection 2024 Mar.

  PMID: 38390395 DERIVED

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Stu White, FRCA BSc MA

  Consultant Anaesthetist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Anaesthetist, Chief Investigator

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: April 5, 2023
• Study Start: March 3, 2017
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: From submission for publication, indefinite
• Access Criteria: Oral/written application to PI

Locations

GB (1)