Opioid-Redox Study

NCT03105232 | Unknown

• 1 other identifier: N28/11/16
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Side effects of opioids can from practical view be divided into short-term and long-term. Nervous system disorders are manifested by psychological status changes of the patient and may cause confusion, mental and somatic dependency, dizziness and so on. Influencing the vegetative and cardiovascular system hypotension can occur what is manifestation of vasodilation and decreased myocardial inotropic activity. Another clinical sign is bradycardia and is characterized by general weakness, sweating, collapse can develop. Effects of opioids may cause respiratory depression, bronchospasm and bronchoconstriction. Side effects on the gastrointestinal tract are nausea, vomiting, constipation and less frequently dry mouth. The constipation does not develop tolerance and has to be avoided (dietary modification, laxatives prevention) respectively during long-term opioid treatment obstipation should be affected by blocking peripheral opioid receptors in the gastrointestinal tract by application of an opioid antagonist methylnaltrexone, which does not cross the blood brain barrier, or using naloxone, which is metabolized by "first-pass" metabolism in the liver for example combined preparation containing oxycodone and naloxone (Kulichová, 2012). Known side effects on parenchymatous organ especially on liver is restricted biliary excretion caused by spasm of the biliary tract. Skin manifestations caused by the effects of opioids are urticaria, dermatitis, and pruritus. Renal and urinary disorders may develop as urinary retention and ureteral spasm. Rarely can occur disorders of the immune system, which through the development of hypersensitivity may lead to the development of anaphylactic shock (Kulichová, 2012). Opioids have a negative effect and the endocrine system. Various studies have demonstrated the influence of opioids on regulatory mechanisms. Fundamental changes occur in hypothalamic-pituitary complex, which directs the activities of all the endocrine system. Secretion of hormones of the pituitary gland regulates the nervous system through the hypothalamus, which is the coordination center of autonomic function. The pituitary gland has coordinating function in relation to other endocrine glands, and by production of their hormones affects the peripheral endocrine organs and the targeting tissues (Kulichová, 2012), (Colameco, 2009). Opioids decrease the secretion of gonadotropin-stimulating hormone, resulting in reduced levels of luteinizing hormone. The result of these changes is reduced secretion of testosterone and estradiol what results in symptoms of hypogonadism. Chronic administration of exogenous opioids decreases the levels of adrenocorticotropic hormone and cortisol, as well as their circadian rhythms. The result is a reduction in the response to stress. Effect on prolactin is not entirely clear. Opioids can stimulate the hypothalamus through the thyroid stimulating hormone, which may cause prolonged and increased response to opioids in patients with hypothyroidism. Chronic use of opioids is associated with weight gain, hyperglycemia and diabetes can worsen (Kulichová, 2012). It may be related to central effects through the sympathetic nervous system and impaired insulin secretion. New laboratory measurements show the development of oxidative stress in patients receiving morphine and related drugs (Merdin, 2016). The consequences of these biochemical changes further negatively affect the clinical outcome of the patients. They may become predisposed to excessive progression of previously latent diseases whose manifestations in patients previously were not apparent and there is emergence of new diseases. The present data are essential to create a clinical prospective observational studies to clarify this issue and its conclusions would be essential for new therapeutic options for adjuvant therapy in patients suffering from chronic pain.

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

• Antioxidant enzymes

  SOD, CAT, GPX, Glutation reduktase, glutathion

  2 years

Secondary Outcomes (2)

• Numerical pain scale

  2 years

• Pain detetct score

  2 years

Study Arms (4)

Group A

Morphin, Hydromorfon, Oxycodon

Group B

Buprenorfin

Group C

Fentanyl

Group D

Opioid rotation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with chronic pain who start opioid longterm therapy

You may qualify if:

• opiod therapy

You may not qualify if:

• active chemotherapy or radiotherapy

Sponsors & Collaborators

• Pavol Jozef Safarik University: lead
• F.D. Roosevelt Teaching Hospital with Policlinic Banska Bystrica: collaborator

Study Sites (1)

1st clinic of anesthesiology and intesive care, University hospital of Louis Pasteur

Košice, 041 90, Slovakia

RECRUITING

Study Officials

• Janka Vašková, MD PhD

  Pavol Jozef Šafárik University in Kosice

  PRINCIPAL INVESTIGATOR

• Jana Šimonová, MD PhD

  Louis Pasteur University Hospital in Košice

  STUDY CHAIR

• Daniela Ogurčáková, MD PhD

  Pavol Jozef Šafárik University in Kosice

  STUDY CHAIR

• Peter Čandík, MD PhD

  East Slovak Institute of Cardiovascular Disease in Kosice

  STUDY CHAIR

Central Study Contacts

Ladislav Kocan, MD PhD

CONTACT

+421907440250; kocanladislav@yahoo.com

Igor Martuliak, MD PhD

CONTACT

+421907440250; imartuliak@nspbb.sk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Ladislav Kočan PhD

Study Record Dates

• First Submitted: April 2, 2017
• First Posted: April 7, 2017
• Study Start: August 20, 2021
• Primary Completion: November 21, 2021
• Study Completion: December 1, 2022
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)