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

NCT06459986 | Recruiting

• 1 other identifier: p-2024-15423
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Orthopedic Disorder

Keywords

Regional anaesthesia; Spinal anaesthesia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Spinal anaesthesia

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants scheduled for elective surgical procedures performed in spinal anaesthesia

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Aleris Hospital: collaborator

Study Sites (2)

Anæstesiologisk Afd

Hillerød, 3400, Denmark

RECRUITING

Aleris-Ringsted

Ringsted, 4100, Denmark

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Kai HW Lange, MD

  Dept. of Anaesthesiology, Nordsjællands Hospital Hillerød, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai HW Lange, MD

CONTACT

+4531909730; Kai.henrik.wiborg.lange@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 14, 2024
• Study Start: June 3, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)