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

Hip Fractures Clinical Trial

Official title:

A Retrospective, Observational, Single-centre, Cohort Database Analysis of the Haemodynamic Effects of Low-dose Spinal Anaesthesia for Hip Fracture Surgery.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05799300
• Other study ID #: RoyalSussex
• Status: Active, not recruiting
• Start date: March 3, 2017
• Est. completion date: May 24, 2023

Study information

• Verified date: March 2023
• Source: Royal Sussex County Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Approximately 65, 000 hip fractures occur in the UK each year, and more than 99% are repaired by surgery. Roughly half of patients receive spinal anaesthesia, where a small amount (usually ~ 2.5mls) of local anaesthetic is injected into the lower back, around the nerves that go to and from the hip.

The investigator has found that low blood pressure (hypotension) is very common during surgery (occurring in at least > 30%, depending on the definition of hypotension), and appears to be significantly linked to a greater chance of death within a month after surgery (~3% rise in mortality/5 mmHg fall in SBP).

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, including fluid overload with heart failure, and cardiac/kidney/gut ischaemia.

Prevention involves giving anaesthesia at lower doses. UK national guidelines recommend that lower doses are given (< 2mls 0.5% hyperbaric bupivacaine), 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 (i.e. invasively) or often enough (i.e. > every 5 minutes).

The ASAP 2 study suggested that a safe level of low blood pressure occurs when only 1.44 mls 0.5% hyperbaric/normobaric spinal anaesthesia is administered, and the investigator has been using this amount (1.5mls) in Brighton since 2011.

Recently, it has become possible to transfer vital signs data from anaesthetic monitors to storage computers for medicolegal purposes (eg in Coroner's investigations - approximately 4000 people in the UK die annually within a month of hip fracture surgery).

However, analyzing such observational medicolegal data should also allow accurate description of how blood pressure changes around the time of surgery, and in patient groups that are normally excluded from prospective research (eg the very old, the very frail, people with dementia). By comparing this data to published national data from the ASAP 1 study, it should be possible to determine whether lower doses of spinal anaesthesia are linked with a lower rate of low blood pressure during surgery. By merging individuals' data with that held on the Brighton Hip Fracture Database, it should be possible to determine whether prevalence (and/or depth+duration of hypotension) are correlated with outcomes (survival, length of inpatient stay) after hip fracture repair.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: May 24, 2023
• Est. primary completion date: May 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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).

2. For whom crude vital signs data have been stored in pseudo-anonymised electronic form on secure hospital computers, for medico-legal reference

Exclusion Criteria:

1. People with hip fracture receiving conservative management during the study period;

2. People with hip fracture requiring total hip arthroplasty (for whom larger volumes of spinal anaesthesia are used);

3. People with hip fracture administered spinal anaesthesia other than 1.3 mls 0.5% hyperbaric bupivacaine;

4. People meeting inclusion criteria for whom vital signs could not be stored electronically due to equipment failure.

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Royal Sussex County Hospital	Brighton	E Sussex

Sponsors (1)

Lead Sponsor	Collaborator
Royal Sussex County Hospital

Country where clinical trial is conducted

United Kingdom, 

References & Publications (8)

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. — View Citation

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 — View Citation

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 — View Citation

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

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

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 o — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The cohort prevalence of hypotension	Cohort prevalence of hypotension, variably defined as: Fall in systolic blood pressure (SBP) from baseline > 20%; Fall in systolic blood pressure (SBP) from baseline > 30%; Fall in mean arterial pressure (MAP) from baseline > 20%; Fall in mean arterial pressure (MAP) from baseline > 30%; Lowest SBP < 90 millimetres of mercury (mmHg); Lowest SBP < 100 mmHg; Lowest MAP < 70 mmHg; Lowest MAP < 55 mmHg.	During anaesthesia and surgery
Secondary	Mean depth x duration area under curve product for cohort hypotension after low dose spinal anaesthesia for hip fracture 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
Secondary	Quantification of cohort systolic and mean arterial blood pressure changes before spinal administration	Describing any effects of propofol sedation and local anaesthetic nerve block	During anaesthesia and surgery
Secondary	Effective cohort duration of spinal anaesthesia	Including number of augmentatory anaesthetic interventions required in mean (SD) time from spinal administration to surgical skin closure	During anaesthesia and surgery
Secondary	Correlations between individual (a) hypotension (b) hypotension depth/duration product and outcomes (death at 30 days, length of stay in hospital)	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