Prevalence of Pain in Hospitalized Cirrhotic Patients

Cirrhosis Clinical Trial

— LIVERPAIN  

Official title:

Etude de la prévalence de la Douleur Chez le Patient Cirrhotique hospitalisé

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06062108
• Other study ID #: 2023-CHITS-009
• Secondary ID: 2023-A01529-36
• Status: Recruiting
• Start date: November 10, 2023
• Est. completion date: November 2024

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
• Contact: Sophie LAFOND
• Phone: 0483772062
• Email: sophie.lafond[@]ch-toulon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Cirrhosis
• Fibrosis
• Hepatic Fibrosis
• Neuralgia
• Pain, Acute
• Pain, Chronic
• Pain, Neuropathic

Intervention

Other:
• Pain evaluation
All included patients will have an evaluation of their pain, if they have no pain, the assessment stop with one date (pain or no pain), if they have pain, an assessment is done (localization of the pain, pain intensity), if they have a pain duration over 3 months, a DN4 questionnaire, HAD scale, ISI scale and SF-1 questionnaire is evaluated.

Locations

Country	Name	City	State
France	Centre Hospitalier de la Dracénie	Draguignan	Var

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of pain in cirrhotic patients hospitalized at the Dracénie hospital in Draguignan	The investigator ask the participant about the presence or absence of pain felt by the patient.	1 day
Secondary	Assess pain location	The pain location will be assessed using a topographic self-assessment tool used in adults	1 day
Secondary	Assess pain number	The pain location will be assessed using a topographic self-assessment tool used in adults	1 day
Secondary	Assess the intensity and chronicity of pain	The intensity of pain will be assessed by the numerical pain scale : Minimum : 0 (no pain) and Maximum : 10 (intense pain). Pain will be considered chronic if the patient has had at least one pain for more than 3 months according to the International Association for the study of Pain definition.	1 day
Secondary	Assess the type of chronic pain	The type of chronic pain will be assessed using the DN4 questionnaire, questions 1 and 2 only relating to the patient's interview. The patient's score is rated out of 7 points and the diagnosis of neuropathic pain (ND) is made if the score is equal to or greater than 3/7.	1 day
Secondary	Evaluating sleep in patients with chronic pain	The sleep of patients with chronic pain will be assessed using the "Sleep Severity Index" (ISI) sleep scale. The total score varies between 0 and 28; between 0-7 = Absence of insomnia, between 8-14 = Subclinical insomnia (mild), between 15-21 = Clinical insomnia (moderate) and between 22-28 = Clinical insomnia (severe).	1 day
Secondary	Evaluating quality of life in patients with chronic pain	Quality of life will be assessed by SF-12 questionnaire. The SF-12 questionnaire is a validated 12-item quality-of-life self-assessment scale translated into French. It is a shortened version of the Medical Outcomes Study Short-Form General Health Survey (SF-36), comprising only 12 of the 36 questions, and determines a respondent's profile in 8 domains: physical function, physical role, physical pain, general health, vitality, social functioning, emotional role and mental health.; Each question is evaluated on a scale with 3 or 5 possible response levels. Several items are grouped together to form a score for each domain, ranging from 0 to 100.; The quality of life of patients with chronic pain is assessed by the overall score obtained on the SF-12 questionnaire. A high score corresponds to a better state of health/quality of life.	1 day

External Links

•   Cirrhose une maladie du foie inflammatoire. 13/07/2017. Consultable sur ce lien: Cirrhose · Inserm, La science pour la santé.
•   Serfaty L. Données de la cohorte CONSTANCES. SNFGE/AFEF 2019.