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NCT Number: NCT06459986

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Anæstesiologisk Afd, Hillerød, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Duration of spinal anasthesia 1

    Time frame: 12 hours

    Time from subarachnoid LA administration to Bromage score < 3

  2. Duration of spinal anaesthesia 2

    Time frame: 12 hours

    Time from subarachnoid LA administration to Bromage score = 1

Study contacts

Contact information is provided by the study sponsor or research team.

Kai HW Lange, MD

CONTACT

[email protected]

+4531909730

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Collaborators

  • Aleris Hospital

Registry information

Official study title

The Duration of Spinal Anaesthesia - a Prospective Observational Cohort Study

Acronym: Spinalrocks

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 14, 2024
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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