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

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.

Study Overview

• Status: Recruiting
• Conditions: Orthopedic Disorder

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Kai HW Lange, MD; Phone Number: +4531909730; Email: Kai.henrik.wiborg.lange@regionh.dk

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Recruiting
    • Anæstesiologisk Afd
    • Contact: Kai Lange, MD; Email: kai.henrik.wiborg.lange@regionh.dk
  • Ringsted, Denmark, 4100
    • Recruiting
    • Aleris-Ringsted
    • Contact: Morten Lind, MD; Email: morten.lind@aleris.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Adult participants scheduled for elective surgical procedures performed in spinal anaesthesia

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Spinal anaesthesia; Participants scheduled for orthopaedic surgery performed in spinal anaesthesia with or without sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of spinal anasthesia 1	Time from subarachnoid LA administration to Bromage score < 3	12 hours
Duration of spinal anaesthesia 2	Time from subarachnoid LA administration to Bromage score = 1	12 hours

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Collaborators: Aleris Hospital
• Investigators: Principal Investigator: Kai HW Lange, MD, Dept. of Anaesthesiology, Nordsjællands Hospital Hillerød, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: June 4, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Regional anaesthesia; Spinal anaesthesia
• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: p-2024-15423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No