Clinical trial NCT06459986: The Duration of Spinal Anaesthesia - a Prospective, Observational Cohort Study
Official title: The Duration of Spinal Anaesthesia - a Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Orthopedic Disorder
Keywords: Regional anaesthesia
Spinal anaesthesia
Lead sponsor: Nordsjaellands Hospital
Sponsor class: OTHER
Collaborators: name: Aleris Hospital
First posted: 2024-06-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants scheduled for elective surgical procedures performed in spinal anaesthesia

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.

Eligibility criteria: Inclusion Criteria:

* Scheduled for elective orthopaedic surgical procedures performed in spinal anaesthesia, ASA 1-4.

Exclusion Criteria: Age \< 18 years, anticoagulant medication therapy not paused according ESAIC/ESRA 2022 guidelines, local infection at the lumbar puncture site, bleeding disorder, unable to cooperate with the spinal anaesthesia procedure.

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Primary outcomes:
measure: Duration of spinal anasthesia 1
timeFrame: 12 hours
measure: Duration of spinal anaesthesia 2
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Hillerød
country: Denmark
facility: Anæstesiologisk Afd
city: Ringsted
country: Denmark
facility: Aleris-Ringsted
Study officials:
affiliation: Dept. of Anaesthesiology, Nordsjællands Hospital Hillerød, Denmark
name: Kai HW Lange, MD
role: PRINCIPAL_INVESTIGATOR
References: