Effect of pre-operative pain treatment on postoperative outcome after total hip or knee replacement surgery

Phase 1

• Conditions: MedDRA version: 19.0Level: PTClassification code 10031161Term: OsteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 19.0Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 19.0Level: LLTClassification code 10020108Term: Hips osteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Osteoarthritis (knee or hip); Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-004313-41-NL
• Lead Sponsor: MCG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-24
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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 49
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

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 clinical trial of medicinal product
• Study Design: Not specified