Spinal Anaesthesia vs. General Anaesthesia for THA, TKA and UKA

NCT05706844 | Completed Phase 4

• 1 other identifier: 2022-501221-21-00
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this randomized clinical trial is to investigate the postoperative recovery following hip and knee arthroplasty procedures depending on the use of either spinal anaesthesia (SA) or general anaesthesia (GA). The main questions are:

• Are more patients able to be safely mobilized within 6 hours postoperatively when using GA compared to SA?
• Does postoperative pain, nausea and vomiting, dizzyness, occurence of delirium and urinary retention differ between the anaesthetic methods? Participants, scheduled for total hip, total knee and unicomartmental knee arthroplasty, will be randomized to recieve spinal anaesthesia or general anaesthesia in relation to surgery. At 6 hours postoperatively a physiotherapist will conduct a 5-meter walking test to evaluate whether the participant can be safely mobilized.

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee

Keywords

Hip arthroplasty; Knee arthroplasty; Unicompartmental knee arthroplasty; General anaesthesia; Spinal anaesthesia; Hip osteoarthritis; Knee osteoarthritis; Fast-track surger

Outcome Measures

Primary Outcomes (1)

• Ability to be mobilsed safely within 6 hours of surgery

  5-meter walking test where a physiotherapist evaluates whether the participant can be safely mobilized within 6 hours of surgery.

  within 6 hours postoperatively.

Secondary Outcomes (4)

• Fulfilment of discharge criteria

  On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted.

• Pain score

  On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted.

• Opioid use in Morphine Milligram Equivilents within the first 6 hours of surgery

  On the day of surgery: Within the first 6 hours after surgery.

• Nausea Score

  On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted.

Other Outcomes (3)

• Vital signs - systolic blood pressure

  On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted.

• Vital signs - diastolic blood pressure

  On the day of surgery: at 4 hours postoperatively and 6 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00 and at 18.00. This will be asses as long as the patient is admitted.

• Quality of Recovery-15 score

  On the day of surgery: at 4 hours postoperatively. From postoperative day 1 and until discharge (on average 1 day): at 10.00. This will be asses as long as the patient is admitted.

Study Arms (2)

Spinal Anaesthesia (SA)

EXPERIMENTAL

Patients undergoing total hip, total knee or unicompartmental knee arthroplasty are anaesthetized using: Plain or heavy Bupivacaine hydrochloride 10 mg (2 mL)

Drug: Spinal anesthesia

General Anaesthesia (GA)

EXPERIMENTAL

Patients undergoing total hip, total knee or unicompartmental knee arthroplasty are anaesthetized using: Propofol (induction: 1.0-2.0 mg/kg. infusion: 3-5 mg/kg/hour) + Remifentanil (induction: 3-5 mcg/kg, infusion: 0.5 mcg/kg/min)

Drug: General anaesthesia

Interventions

Spinal anesthesia DRUG

plain or heavy Bupivacaine hydrochloride 10 mg (2 mL) injected in the spinal canal

Also known as: Spinal anaesthesia

Spinal Anaesthesia (SA)

General anaesthesia DRUG

Propofol (induction: 1.0-2.0 mg/kg. infusion: 3-5 mg/kg/hour) + Remifentanil (induction: 3-5 mcg/kg, infusion: 0.5 mcg/kg/min) given intravenously

General Anaesthesia (GA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical and radiological hip or 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.

You may not qualify if:

• 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.
• Women considered fertile but without sufficient birth control.

Sponsors & Collaborators

• Anders Troelsen: lead
• Vejle Hospital: collaborator

Study Sites (2)

Christian Bredgaard Jensen

Hvidovre, 2650, Denmark

Location

Vejle Hospital

Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee

Interventions

Anesthesia, Spinal; Anesthesia, General

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Anders Troelsen, MD, DMSc

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Physcians and nurses in the surgical department are not able to be blinded. But outcome assesors (ie. physiotherapists, research personel) are not aware of the treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, consultant physician

Model Details: Each of the three arthroplasty procedures are investigated in a 2-arm randomised trial: Total hip arthroplasty - either spinal anaesthesia or general anaesthesia. Total knee arthroplasty - either spinal anaesthesia or general anaesthesia. Unicompartmental knee arthroplasty - either spinal anaesthesia or general anaesthesia.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 31, 2023
• Study Start: March 6, 2023
• Primary Completion: April 6, 2025
• Study Completion: April 6, 2025
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)