Orthopedic DisorderSpinalrocksNCT06459986
The Duration of Spinal Anaesthesia - a Prospective, Observational Cohort Study
An observational study of Orthopedic Disorder, run by Nordsjaellands Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthopedic Disorder
- How many people
- 2,000 participants
- Where
- 2 sitesDenmark
- Study dates
- 3 Jun 2024to 1 Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult participants scheduled for elective surgical procedures performed in spinal anaesthesia
Who may be able to join
- Scheduled for elective orthopaedic surgical procedures performed in spinal anaesthesia
- ASA 1-4.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Anæstesiologisk Afd
Hillerød, 3400
Kai Lange, MD, kai.henrik.wiborg.lange@regionh.dk
- Recruiting
Aleris-Ringsted
Ringsted, 4100
Morten Lind, MD, morten.lind@aleris.dk
About this study
Official title: 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.
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.
- Conditions
- Orthopedic Disorder
- Keywords
- Regional anaesthesia, Spinal anaesthesia
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spinal anaesthesia | Participants scheduled for orthopaedic surgery performed in spinal anaesthesia with or without sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of spinal anasthesia 1
Time from subarachnoid LA administration to Bromage score < 3
Measured: 12 hours
Duration of spinal anaesthesia 2
Time from subarachnoid LA administration to Bromage score = 1
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start3 Jun 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aleris Hospital
- Responsible party
- Sponsor
- Investigators
- Kai HW Lange, MD, Principal investigator, Dept. of Anaesthesiology, Nordsjællands Hospital Hillerød, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459986
- Sponsor's protocol ID
- p-2024-15423
- Acronym
- Spinalrocks
- Status last verified
- Jan 2026
- First submitted
- 4 Jun 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Duration of Spinal Anaesthesia - a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT06459986
- Acronym / sponsor ID
- Spinalrocks / p-2024-15423
- Conditions
- Orthopedic Disorder
- Keywords
- Regional anaesthesia, Spinal anaesthesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Aleris Hospital
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal anaesthesia | – | –Participants scheduled for orthopaedic surgery performed in spinal anaesthesia with or without sedation |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants scheduled for elective surgical procedures performed in spinal anaesthesia
Key inclusion criteria (2 listed)
- Scheduled for elective orthopaedic surgical procedures performed in spinal anaesthesia
- ASA 1-4.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Duration of spinal anasthesia 1
Time frame: 12 hours
Time from subarachnoid LA administration to Bromage score < 3
Duration of spinal anaesthesia 2
Time frame: 12 hours
Time from subarachnoid LA administration to Bromage score = 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kai HW Lange, MD principal investigator
Dept. of Anaesthesiology, Nordsjællands Hospital Hillerød, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedic Disorder, run by Nordsjaellands Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai HW Lange, MD (+4531909730, Kai.henrik.wiborg.lange@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of spinal anasthesia 1 (time frame: 12 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.