UDOPAL Study: Home-Based Interventional Approach to Pain Management in Home-Hospitalized Patients

NCT07265492 | Not Yet Recruiting

• 2 other identifiers: UDOPALCEIm La Fe Acta N.600-08.10.25
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The UDOPAL Study proposes an innovative home-based care approach for the management of pain in patients admitted to the Home Hospitalization Unit (UHD). This model incorporates interventional pain management techniques into the clinical practice of home-hospital professionals, supported when necessary by specialists from the Pain Medicine Unit. Pain is a prevalent and often undertreated problem in patients receiving home hospitalization, where complex or oncologic pain may require specialized procedures that traditionally are only performed in hospital settings. The UDOPAL model aims to bridge this gap by providing ultrasound-guided and minimally invasive pain procedures directly at the patient's home, including nerve blocks, infiltrations, and other targeted interventions. This observational, prospective study evaluates the feasibility, safety, and clinical impact of implementing interventional pain management at home. Adult patients with chronic, oncologic, or complex pain will be included. Outcomes include pain intensity, opioid use, functional improvement, quality of life, and patient satisfaction, as well as adverse events related to the techniques. The study seeks to provide scientific evidence supporting a new model of interventional home-based pain care that improves comfort, continuity of care, and efficient use of healthcare resources. The project was approved by the Ethics Committee (CEIm Hospital Universitario y Politécnico La Fe, Acta No. 600, 08/10/2025) and is conducted at Hospital de Manises (Valencia, Spain).

Conditions

Chronic Pain; Cancer Pain; Neuropathic Pain; Palliative Care

Keywords

UDOPAL; Home Hospitalization; Palliative Care; Palliative Pain Care; Nerve Blocks; Chronic Pain; Cancer Pain; Pain Relief; Opioid Reduction; Multidisciplinary Model; Hospital-at-Home; Home Health Care; Home Medical Services; Integrated Home Care; Hospital in the Home; Domiciliary Care; Home-Based Hospital Care; Interventional Pain Management

Outcome Measures

Primary Outcomes (2)

• Change in Pain Intensity (Numeric Rating Scale, NRS 0-10)

  Pain intensity will be assessed using the Numeric Rating Scale (NRS, 0-10) for patients able to self-report pain. The primary outcome represents the mean reduction in NRS pain intensity from baseline to each follow-up point.

  Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU)

• Change in Pain Intensity (PAINAD 0-10 for patients with cognitive impairment)

  Pain intensity will be assessed using the Pain Assessment in Advanced Dementia Scale (PAINAD, 0-10) for patients with cognitive impairment or communication difficulties. The primary outcome represents the mean reduction in PAINAD score from baseline to each follow-up point.

  Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU)

Secondary Outcomes (14)

• Opioid Consumption

  Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU)

• Functional Status

  Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU)

• Patient and Family Satisfaction

  Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU)

• Professional Perception of Feasibility

  baseline and at completion of the implementation phase (approximately 1 month)

• Change in Quality of Life (EQ-5D-5L Score)

  Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU)

Study Arms (1)

UDOPAL Cohort Description: Prospective observational cohort including patients admitted

Other: UDOPAL model

Interventions

UDOPAL model OTHER

The UDOPAL model proposes a novel clinical approach to manage pain in patients hospitalized at home through the use of interventional pain techniques. The model enables trained home-hospitalization professionals to perform minimally invasive, ultrasound-guided procedures at the patient's home when conventional pharmacological strategies are insufficient. This observational study evaluates the feasibility, safety, and clinical effectiveness of this innovative home-based pain management approach, focusing on pain intensity reduction, opioid-sparing effect, improvement in functional status, and patient and family satisfaction.

UDOPAL Cohort Description: Prospective observational cohort including patients admitted

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 admitted to the Home Hospitalization Unit (HHU) of the Manises Health Department who present with acute, chronic, oncologic, or complex pain requiring assessment for interventional pain management at home. The study population includes individuals with adequate clinical stability to undergo minimally invasive procedures in the domiciliary setting, as evaluated by a UDOPAL-trained physician. Patients may present a wide range of pain etiologies, functional limitations, or palliative needs commonly managed during home hospitalization.

You may qualify if:

• Adult patients (≥18 years old) admitted to the Home Hospitalization Unit (UHD) of the Manises Health Department.
• Presence of active pain, classified as mild, moderate, or severe.
• Clinical assessment indicating suitability for interventional pain management, as determined by a UDOPAL-trained physician.
• Physical and clinical conditions that allow the performance of interventional procedures at home under standardized safety precautions.
• Signed informed consent obtained from the patient and/or a legally authorized representative in cases of incapacity.

You may not qualify if:

• Very limited life expectancy (estimated survival \<72 hours) or terminal/agonal condition.
• Contraindication to interventional pain procedures, including:
• Uncorrectable coagulopathy.
• Systemic infection or local infection at the puncture site.
• Documented allergy to any of the planned medications.
• Tumor located in the infiltration area.
• Pregnancy or breastfeeding.
• Altered level of consciousness or severe cognitive impairment without a responsible family member or without the possibility of obtaining valid informed consent.
• Home environment conditions that do not ensure minimal hygiene, safety, or logistical support (e.g., inadequate lighting, lack of privacy, insufficient family assistance, or limited access for the medical team).
• Explicit refusal by the patient and/or family to undergo interventional pain procedures.
• Refusal to participate in the study.

Sponsors & Collaborators

• Hospital de Manises: lead

MeSH Terms

Conditions

Chronic Pain; Cancer Pain; Neuralgia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Estefanía Romero-Serrano, MD, PhD, EDAIC

CONTACT

961 84 50 00; romero_estserrano@gva.es; draromeroserrano@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, UDOPAL Intervention Program, Pain Medicine Unit, Hospital de Manises

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): October 8, 2026
• Study Completion (Estimated): October 8, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share