Prevalence of Pain in Hospitalized Cirrhotic Patients

NCT06062108 | Completed

• 2 other identifiers: 2023-CHITS-0092023-A01529-36
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Fibrosis; Pain, Acute; Cirrhosis; Pain, Chronic; Pain, Neuropathic

Keywords

cirrhosis; hepatic fibrosis; pain; evaluation or assessment; neuropathic pain; chronic pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Assess pain location

  1 day

• Assess pain number

  1 day

• Assess the intensity and chronicity of pain

  1 day

• Assess the type of chronic pain

  1 day

• Evaluating sleep in patients with chronic pain

  1 day

Study Arms (1)

Patients with cirrhosis

Patients hospitalized during the inclusion period with cirrhosis medical history

Other: Pain evaluation

Interventions

Pain evaluation OTHER

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.

Also known as: Pain assessment

Patients with cirrhosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer: lead

Study Sites (1)

Centre Hospitalier de la Dracénie

Draguignan, Var, 83300, France

Location

Related Publications (4)

• 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.

  PMID: 36405106 BACKGROUND

• 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.

  PMID: 33436531 BACKGROUND

• 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.

  PMID: 29552453 BACKGROUND

• 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.

  PMID: 11208726 BACKGROUND

Related Links

• Piano V, Bellone M, Pouymayou J. Antalgie et insuffisance hépatique : La quadrature du cercle ? Le Flyer, Nov 2023.
• 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.

MeSH Terms

Conditions

Fibrosis; Liver Cirrhosis; Acute Pain; Chronic Pain; Neuralgia; Pain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases; Neurologic Manifestations; Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Virginie PIANO, MD

  Centre Hospitalier de la Dracénie, Draguignan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 2, 2023
• Study Start: November 10, 2023
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)