Cognitive Study on the Use of Central Analgesic Drugs in the Management of Chronic Pain
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Parma
- Enrollment
- 300
- Primary Endpoint
- adherence to therapy
Study Overview
Brief Summary
Chronic pain is defined as pain that persists after healing of the wound that caused it, and can occur even in the absence of any obvious pathological trigger. In our country, there is a growing interest in the proper management of the disease "pain".
Pain is also the first symptom of the disease in 20 -50% of patients with neoplastic disease and from 75% to 90% of patients with advanced cancer suffers from chronic pain .
However, pain management is mostly inadequate. This study aims to assess the Italian clinical practice in reference to the pharmacological management of chronic pain by health professionals involved in the treatment of pain in some centers belonging to the Italian network of pain therapy.
Detailed Description
Chronic pain is defined as pain that persists after healing of the wound that caused it, and can occur even in the absence of any obvious pathological trigger. In our country, there is a growing interest in the proper management of the disease "pain".
In fact, the Ministry of Health, first in Europe, introduced a law in 2010 (March 15, 2010, No. 38) to provide for the sick, cancer or not, easy access to the necessary care and to provide specialists a specific training course.
Pain is also the first symptom of the disease in 20 -50% of patients with neoplastic disease and from 75% to 90% of patients with advanced cancer suffers from chronic pain (Marcus 2011).
The "pain disease" is one of the most common causes of access to medical care so it should be recognized as a complex health and research problem, being one of the most expensive and investigated conditions in our society (Pizzo and Clark, 2012; Gupta et al. , 2010; Dagenais et al., 2008).
It has a significant impact on the subjective perception of health status, influence daily activities and is associated with symptoms of depression and other psychological problems that affect the quality of life of the patient (end of 2011 Gureje et al., 1998; Bair et al., 2003, Portenoy, 1996).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Males and females over the age of 18 years
- •Chronic neuropathic and / or nociceptive and / or mixed pain, whereby clinicians considers necessary to start opioid therapy
- •Signed informed consent
Exclusion Criteria
- •Males and females aged under 18 years
- •Patients already receiving opioid analgesic drugs or drugs of the class MOR-NRI.
- •Taking abuse drugs or alcohol abuse
- •Patients with contraindications to the use of central analgesic drugs
- •Patients who refuse participation
- •Prior cognitive impairment or mental retardation
- •Severe immunodeficiency (WBC <4,000)
- •Severe renal impairment (serum creatinine > 2g/dl or Creatinine clearance <30 ml / h)
- •Hepatic impairment (Cholinesterase <2.000UI or INR> 2)
Outcomes
Primary Outcomes
adherence to therapy
Time Frame: 18 months
to evaluate the proportion of patients who continues therapy with benefit after one month of enrollment
Secondary Outcomes
- adherence at 6 months(18 months)
- side effects(18 months)
- quality of life(18 months)
Investigators
Christian Compagnone
MD
University of Parma