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

NCT ID: NCT06459986

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2026-12-01

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.

Conditions

Orthopedic Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Spinal anaesthesia

Participants scheduled for orthopaedic surgery performed in spinal anaesthesia with or without sedation

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aleris Hospital

OTHER

Sponsor Role: collaborator

Nordsjaellands Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kai HW Lange, MD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Anaesthesiology, Nordsjællands Hospital Hillerød, Denmark

Locations

Anæstesiologisk Afd

Hillerød, , Denmark

Site Status: RECRUITING

Aleris-Ringsted

Ringsted, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Kai HW Lange, MD

Role: CONTACT

Kai.henrik.wiborg.lange@regionh.dk

+4531909730

Facility Contacts

Kai Lange, MD

Role: primary

kai.henrik.wiborg.lange@regionh.dk

Morten Lind, MD

Role: primary

morten.lind@aleris.dk

Other Identifiers

p-2024-15423

Identifier Type: -

Identifier Source: org_study_id