Clinical trial on Spinal Anaesthesia vs. General Anaesthesia (SAGA) on recovery after hip and knee replacements

Phase 1

Recruiting

• Conditions: Osteoarthritis of the hip and knee; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; Therapeutic area: Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]

• Registration Number: CTIS2022-501221-21-00
• Lead Sponsor: Hvidovre Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-19
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 222

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified