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.

Status Active, not recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

• NCT number: NCT05799300
• Study type: Observational
• Source: Royal Sussex County Hospital
• Status: Active, not recruiting
• Start date: March 3, 2017
• Completion date: May 24, 2023