Oxidative Balance in Opioid Therapy

Medical University of Bialystok

Status: Completed

Conditions: Opioids; Pain

Treatments: Diagnostic Test: biochemical measurements

Study type: Interventional

Funder types: Other

Identifiers

NCT04227223

R-I-002/307/2019

Details and patient eligibility

About

The oxidative - antioxidative balance is the crucial mechanism of opioid-induced immunomodulation. Additionally, impairement of cognitive function during opioid therapy is another important side- effect. This phenomenon was clearly described in opioids abuse. This is interesting to evaluate the importance of this subjects in chronic pain patients. The aim of the study was to investigate the oxidative - antioxidative homeostasis and cognitive functions using serum total oxidative capacity (TOC) and total antioxidative capacity (TAC) tests and Brain Derivered Neutrophic Factor (BDNF) in patient with chronic non-cancer pain treated with opioids.

Full description

The project was approved in Ethical Committee and supported by Medical University of Bialystok (Poland). The serum TOC and TAC measurements were performed in total group of 50 adult patients: Study Group - 36 patients with chronic Low-Back Pain with opioids pharmacotherapy and Control Group - 14 patients, healthy volunteers. In Study Group anthropometric parameters, duration in opioid therapy, type of opioid, total dose, and form of application were registered.TOC, TAC, and BDNF measurements were performed using ImAnOx, PerOx, BDNF tests (Immundiagnostik, Germany).Data were analyzed using non-parametric tests.

Enrollment: 50 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• minimally, 6 months opioid therapy in chronic Low- Back Pain

Exclusion criteria

• depression, steroids- local or systemic administration

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Study Group

Experimental group

Description:

Study Group - 36 patients with chronic Low-Back Pain with opioids pharmacotherapy

Treatment:

Diagnostic Test: biochemical measurements

Control Group

Active Comparator group

Description:

Control Group - 14 patients, healthy volunteers.

Treatment:

Diagnostic Test: biochemical measurements