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The effect of a new peripheral nerve block, popliteal plexus block, on postoperative opioid use, postoperative pain, muscle strength of the leg and mobilization after total knee replacement surgery - a randomized, controlled, blinded study

Phase 1
Conditions
Postoperative pain following a total knee arthroplasty surgery
MedDRA version: 21.1Level: LLTClassification code 10036236Term: Postoperative pain reliefSystem Organ Class: 100000004865
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Registration Number
EUCTR2021-000242-17-DK
Lead Sponsor
Region Hospital Silkeborg
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
165
Inclusion Criteria

Scheduled to undergo primary total knee arthroplasty in spinal anesthesia

Able to perform a Timed Up and Go (TUG) test

Age > 50 years old

Ability to give their written informed consent to participating in the study after having fully understood the contents of the study

American Society of Anesthesiologists (ASA) physical status 1, 2, or 3

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120

Exclusion Criteria

Patients who cannot cooperate

Patients who cannot understand or speak Danish.

Patients with allergy or intolerance to the medicines used in the study

Patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl)

Patients suffering from alcohol and/or drug abuse – based on the investigator's assessment

Diagnosed with chronic central or peripheral neurodegenerative disorders

Body Mass Index > 40

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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