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RecruitingNCT06459986SpinalrocksUpdated Jan 20, 2026

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

An observational study in Orthopedic Disorder, sponsored by Nordsjaellands Hospital. Recruiting at 2 sites in Denmark. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Nordsjaellands Hospital · Observational

From the registry’s dates

  • Started Jun 2024; still recruiting 2 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Orthopedic Disorder

Keywords

  • Regional anaesthesia
  • Spinal anaesthesia
03

In context

Musculoskeletal Diseases

657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 126 across 201 observational studies indexed under Musculoskeletal Diseases.

Browse Musculoskeletal Diseases studies →

Lead sponsor

Nordsjaellands Hospital is the lead sponsor of 88 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adult participants scheduled for elective surgical procedures performed in spinal anaesthesia

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Spinal anaesthesia

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

06

What researchers measure

Primary outcomes

  1. Duration of spinal anasthesia 1

    Time from subarachnoid LA administration to Bromage score \< 3

    Time frame: 12 hours

  2. Duration of spinal anaesthesia 2

    Time from subarachnoid LA administration to Bromage score = 1

    Time frame: 12 hours

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06459986
Lead sponsor
Nordsjaellands Hospital
Collaborators
Aleris Hospital
Responsible party
Sponsor
First posted
Jun 14, 2024
Start date
Jun 3, 2024
Primary completion
Aug 1, 2026 (estimated)
Completion
Dec 1, 2026 (estimated)
Last update
Jan 20, 2026

Study contacts

Kai HW Lange, MD
Contact
Kai.henrik.wiborg.lange@regionh.dk
+4531909730
Kai HW Lange, MD
principal investigator · Dept. of Anaesthesiology, Nordsjællands Hospital Hillerød, Denmark

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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