Effect of pre-operative pain treatment by means of duloxetine on postoperative outcome after total hip or knee arthroplasty

Phase 3

Completed

• Conditions: degenerative arthritis; Osteoarthritis; 10023213

• Registration Number: NL-OMON41519
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 119

Inclusion Criteria

1. Primary hip/knee osteoarthritis (based on clinical and radiological ACR-criteria)
2. Age >18 years
3. A neuropathic or at least a mixed neuropathic / nociceptive pain phenotype (m-painDETECT-score >12)

Exclusion Criteria

General exclusion criteria:
1. Surgical hip or knee joint procedures less than 1 year previously
2. Cognitive and/or neurological disorders that could interfere strongly with questionnaire surveys (e.g. Dementia)
3. Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation.
4. Planned or intended to perform THA or TKA within the study duration (present planned arthroplasty not included)
5. A history of peripheral nerve injury
6. Previous exposure to Duloxetine;Duloxetine related exclusion criteria:
7. Allergy to study medication or compounds of the Duloxetine capsule (or another SNRI);
8. History of peptic ulcer disease or bleeding disorder (or other substantial risk factor for bleeding)
9. Psychiatric disorders, other than depression;
10. Severe depression (HADS score >15 on depression subscale);
11. A history of alcohol or other substance abuse (excluding nicotine and caffeine) or dependence within the five years prior to enrollment;
12. Currently pregnant or lactating, our planned to become pregnant within the study period
13. History of cardiac arrhythmias, cardiac failure, myocardial infarct;
14. impaired function of the liver, or known cirrhosis or liver transplantation;
15. severe renal impairment, or had renal transplantation or receiving renal dialysis;
16. Hyponatraemia, or a history of frequent hyponatremias;
17. History of uncontrolled hypertension, history of glaucoma (or with increased intraocular pressure) ,uncontrolled thyroid disease and a history of uncontrolled seizures;
18. Usage of non selective monoamine oxidase (MAO) inhibitors, TCA*s , SSRIs, SNRIs in the last year;
19. Usage of strong CYP1A2-inhibitors

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The degree of postoperative pain, assessed with the pain subscales of the Knee<br /><br>injury and Osteoarthritis Outcome Score (KOOS) or the Hip disability and<br /><br>Osteoarthritis Outcome Score (HOOS).</p><br>