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The Duration of Spinal Anaesthesia - a Prospective, Observational Cohort Study

The Duration of Spinal Anaesthesia - a Prospective Observational Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06459986
Acronym
Spinalrocks
Enrollment
2000
Registered
2024-06-14
Start date
2024-06-03
Completion date
2026-12-01
Last updated
2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic Disorder

Keywords

Regional anaesthesia, 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.

Interventions

None listed

Sponsors

Nordsjaellands Hospital
Lead SponsorOTHER
Aleris Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Duration of spinal anasthesia 112 hoursTime from subarachnoid LA administration to Bromage score \< 3
Duration of spinal anaesthesia 212 hoursTime from subarachnoid LA administration to Bromage score = 1

Countries

Denmark

Contacts

CONTACTKai HW Lange, MD
Kai.henrik.wiborg.lange@regionh.dk+4531909730
PRINCIPAL_INVESTIGATORKai HW Lange, MD

Dept. of Anaesthesiology, Nordsjællands Hospital Hillerød, Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026