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Clinical Trials/CTIS2022-501221-21-00
CTIS2022-501221-21-00
Recruiting
Phase 1

Randomized trial on Spinal Anaesthesia vs. General Anaesthesia (SAGA) on recovery after total hip, total knee, and unicompartmental knee arthroplasty

Hvidovre Hospital0 sites222 target enrollmentAugust 19, 2022

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Osteoarthritis of the hip and knee
Sponsor
Hvidovre Hospital
Enrollment
222
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 19, 2022
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Clinical and radiological knee osteoarthritis meeting the indications for primary total hip, total knee or unicompartmental knee arthroplasty. \=18 years of age. Able to speak and understand Danish. Able to give informed consent and must be cognitively intact.

Exclusion Criteria

  • Lives in an institution. Uses walking aid such as a walker or a wheelchair. Terminal illness. Has contraindications for either general or spinal anaesthesia. Has objections to receiving either general or spinal anaesthesia. Requires anxiolytics as premedication prior to anaesthesia. Traumatic aetiology as a basis for surgical indication. Altered pain perception and / or neurologic affection due to diabetes or other disorders. Daily preoperative use of opioids \> 30 mg of morphine milligram equivalents (MME). Standard primary arthroplasty procedure is evaluated not to be suitable.

Outcomes

Primary Outcomes

Not specified

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