ymphocyte opioid receptors as innovative biomarkers for osteoarthritic chronic pain: study protocol for the assessment and risk management of opioid tailored therapy, before hip surgery, to prevent chronic pain and opioids tolerance/addiction development

Phase 4

Completed

• Conditions: Total hip arthroplasty for osteoarthritis or aseptic necrosis of the femoral head; Surgery

• Registration Number: ISRCTN12559751
• Lead Sponsor: ISAL Foundation

Brief Summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29258584

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-23
• Study Completion: 2017-11-23
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patients who started opioid analgesics category and will undergo total hip arthroplasty for osteoarthritis or aseptic necrosis of the femoral head
2. Patients who started NonSteroidal Anti-Inflammatory Drugs (NSAIDs) and will undergo total hip arthroplasty (THA) for osteoarthritis or aseptic necrosis of the femoral head
3. Males and female adults (from 18 years old)

Exclusion Criteria

1. Unstable neurological pathologies
2. Uncompensated diabetes
3. Previous abdominal surgery with dynamic ileum risk
4. Viral infective pathologies
5. Patients unable to fill the informed consent form
6. Patients needing post-surgery mechanical ventilation
7. Patients attending a secondary surgery
8. Retreated patients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Expression and functional characteristics of opioid receptors on the lymphocyte surface, measured using peripheral blood analysis (Immunophenotype analysis, Q-PCR, western blotting, ELISA) at T0, T2, T3, T4 and T5<br>2. Bone marrow morphological and morphometric evaluation, using bone marrow biopsy, hematoxylin/eosin staining protocol and cellular immune-phenotypic typization at T2

Secondary Outcome Measures

Name	Time	Method
1. Hip movement, stability, strength, presence of any deformities, joint and functional limitations, evaluated using the Harris Hip Score at T0, T1, T2, T4, T5<br>2. Degree of arthritis/necrosis, measured using axial and anteroposterior pelvic radiographs at T0<br>3. Pain intensity, measured using the NRI scale at T0, T1,T2, T3, T4, T5<br>4. Electrocardiogram, oxygen saturation, invasive and non-invasive blood pressure monitoring at T2<br>5. Side effects evaluation (tolerance or addiction) at T2, T4, T5