Clinical trial NCT06062108: Prevalence of Pain in Hospitalized Cirrhotic Patients
Official title: Etude de la prévalence de la Douleur Chez le Patient Cirrhotique hospitalisé
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cirrhosis
Hepatic Fibrosis
Pain, Acute
Pain, Chronic
Pain, Neuropathic
Keywords: cirrhosis
hepatic fibrosis
pain
evaluation or assessment
neuropathic pain
chronic pain
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with a diagnosis of cirrhosis in his history, hospitalized at the Center Hospitalier de la Dracénie

Brief summary: According to the WHO, pain is an "unpleasant sensory and emotional experience, linked to existing or potential tissue damage, or described in terms suggestive of such damage". It is a legal obligation to evaluate and take care of it (law of 03/04/2022). However, there are still areas where this is not addressed, particularly in cirrhotic patients (Piano V et al. 2023).

The global prevalence of cirrhosis increased by 74.53% between 1990 and 2017 (Liu YB et al, 2022, INSERM France file and Zhai M et al. 2021). In France, the prevalence of cirrhosis is estimated to be 200,000 patients (Cohorte Constances 2017; Serfaty 2019). The causes are varied: toxic (alcohol), viral (hepatitis B, C, HIV), genetic (hemochromatosis, primary biliary cirrhosis) but also iatrogenic or linked to a metabolic syndrome, non-alcoholic fatty liver disease.

The first symptoms of cirrhosis are fatigue, loss of appetite and weight, nausea and vomiting, discomfort and abdominal pain. More serious symptoms may appear such as depression, confusion, sleep disturbances, edema of the lower limbs, ascites, severe pruritus or jaundice. All of these symptoms can be the cause of the pain.

However, to date, there are no studies in France on the epidemiology of pain in patients with cirrhosis (Piano V et al. 2023, Klinge M, et al, 2018). To evaluate the prevalence of pain in cirrhotic patients hospitalized at the Center Hospitalier de la Dracénie in Draguignan. Patients hospitalized at the Dracénie CH with a diagnosis of cirrhosis in its patients will be identified in the various departments by a referring doctor who will have to contact Dr PIANO. The latter, as investigating doctor, will then be able to select the patients meeting the inclusion criteria of the protocol and the informants of the existence of the research. He will explain the study to them in detail, give them sufficient time for reflection before obtaining their oral agreement and giving them the information-no-opposition letter.

The research will require a single consultation lasting between 15 and 45 minutes.

During the visit, the patient will be asked whether or not they are experiencing pain.

Detailed description: The main objective of this study is to evaluate the prevalence of pain in cirrhotic patients hospitalized at the Dracénie hospital in Draguignan.

The secondary objectives of this study are as follows:

1. Assess pain pattern
2. Assess the intensity and chronicity of pain
3. Assess the type of chronic pain
4. Assess sleep in patients with chronic pain
5. Assess the emotional state of patients with chronic pain
6. Evaluate the quality of life of patients with chronic pain

Recruitment methods 30 participants will need to be recruited over a period of 6 months. Patients will be identified during their hospitalization at the Dracénie hospital as part of current practice. These patients must meet the inclusion criteria of the protocol to be recruited.

Eligibility criteria: Inclusion Criteria:

* Patient with a diagnosis of cirrhosis in his history, hospitalized at the Center Hospitalier de la Dracénie;
* Patient aged 18 or over;
* Patient understanding and speaking the French language.

Exclusion Criteria:

* Patient refusal;
* Patient under legal protection (guardianship, curatorship, etc.) or legal protection;
* Pregnant, parturient or breastfeeding woman;
* Patients unable to answer questions for cognitive reasons;
* Any other reason that, in the opinion of the investigator, could interfere with the evaluation of the study objectives.

Primary outcomes:
measure: Prevalence of pain in cirrhotic patients hospitalized at the Dracénie hospital in Draguignan
timeFrame: 1 day
Secondary outcomes:
measure: Assess pain location
timeFrame: 1 day
measure: Assess pain number
timeFrame: 1 day
measure: Assess the intensity and chronicity of pain
timeFrame: 1 day
measure: Assess the type of chronic pain
timeFrame: 1 day
measure: Evaluating sleep in patients with chronic pain
timeFrame: 1 day
measure: Evaluating quality of life in patients with chronic pain
timeFrame: 1 day
Other outcomes:
Locations:
city: Draguignan
country: France
facility: Centre Hospitalier de la Dracénie
state: Var
Study officials:
affiliation: Centre Hospitalier de la Dracénie, Draguignan
name: Virginie PIANO, MD
role: STUDY_DIRECTOR
References:
citation: Liu YB, Chen MK. Epidemiology of liver cirrhosis and associated complications: Current knowledge and future directions. World J Gastroenterol. 2022 Nov 7;28(41):5910-5930. doi: 10.3748/wjg.v28.i41.5910.
citation: Zhai M, Long J, Liu S, Liu C, Li L, Yang L, Li Y, Shu B. The burden of liver cirrhosis and underlying etiologies: results from the global burden of disease study 2017. Aging (Albany NY). 2021 Jan 12;13(1):279-300. doi: 10.18632/aging.104127. Epub 2021 Jan 12.
citation: Klinge M, Coppler T, Liebschutz JM, Dugum M, Wassan A, DiMartini A, Rogal S. The assessment and management of pain in cirrhosis. Curr Hepatol Rep. 2018 Mar;17(1):42-51. doi: 10.1007/s11901-018-0389-7. Epub 2018 Feb 22.
citation: Marchesini G, Bianchi G, Amodio P, Salerno F, Merli M, Panella C, Loguercio C, Apolone G, Niero M, Abbiati R; Italian Study Group for quality of life in cirrhosis. Factors associated with poor health-related quality of life of patients with cirrhosis. Gastroenterology. 2001 Jan;120(1):170-8. doi: 10.1053/gast.2001.21193.