Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459986
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-04
Brief Title:
The Duration of Spinal Anaesthesia - a Prospective Observational Cohort Study
Sponsor:
Nordsjaellands Hospital
Organization:
Nordsjaellands Hospital
Study Overview
Official Title:
The Duration of Spinal Anaesthesia - a Prospective Observational Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Spinalrocks
Brief Summary:
Today surgery in an ambulatory setting is preferred for many reasons Total hip and knee arthroplasty THA and TKA are now procedures where patients can be sent home on the same day of the surgical procedure However this requires substantial knowledge of factors affecting the length of hospital stay In this prospective observational cohort study we will investigate factors that affect the duration of spinal anaesthesia which is often used in THA and TKA The aim is to gather enough data to be able to determine how local anaesthetic volume and dose affect the duration of spinal anaesthesia This will enable us to decide whether spinal anaesthesia is a good option when performing TKA and THA in an ambulatory setting
Detailed Description:
With the increasing health care cost and the scarcity of nursing staff there is considerable focus on providing surgery in an ambulatory setting Total hip and knee arthroplasty THA and TKA are now procedures where selected patients are sent home on the same day after the procedure Therefore knowledge of key factors affecting the length of stay is important One factor is the method of anaesthesia used for the operative procedure
Spinal anaesthesia is often used for THA and TKA and has several advantages compared to general anaesthesia However spinal anaesthesia also has drawbacks because it reduces the force in the legs hindering early mobilisation There are no good data on the duration of spinal anaesthesia Compared to the past there has been a shift towards using lower doses of local anaesthetic LA injected into the subarachnoid space Theoretically this should result in a shorter duration of anaesthesia and this would be of value in an ambulatory setting However if the variation in the duration is high and therefore not predictable for the individual patient spinal anaesthesia has limitations in the ambulatory setting
The objective of the present study is to prospectively collect data on the type and dose of LA injected into the subarachnoid space and the duration of spinal anaesthesia in participants scheduled for orthopaedic surgery in spinal anaesthesia We hypothesise that the mean duration of spinal anaesthesia is positively correlated to the dose of LA injected into the subarachnoid space
Spinal anaesthesia is often used for THA and TKA and has several advantages compared to general anaesthesia However spinal anaesthesia also has drawbacks because it reduces the force in the legs hindering early mobilisation There are no good data on the duration of spinal anaesthesia Compared to the past there has been a shift towards using lower doses of local anaesthetic LA injected into the subarachnoid space Theoretically this should result in a shorter duration of anaesthesia and this would be of value in an ambulatory setting However if the variation in the duration is high and therefore not predictable for the individual patient spinal anaesthesia has limitations in the ambulatory setting
The objective of the present study is to prospectively collect data on the type and dose of LA injected into the subarachnoid space and the duration of spinal anaesthesia in participants scheduled for orthopaedic surgery in spinal anaesthesia We hypothesise that the mean duration of spinal anaesthesia is positively correlated to the dose of LA injected into the subarachnoid space
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None