UDOPAL Study: Home-Based Interventional Approach to Pain Management in Home-Hospitalized Patients
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital de Manises
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Very limited life expectancy (estimated survival <72 hours) or terminal/agonal condition.
Uncorrectable coagulopathy.
Systemic infection or local infection at the puncture site.
Documented allergy to any of the planned medications.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
UDOPAL model
Other interventionThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: UDOPAL Cohort Description: Prospective observational cohort including patients admitted1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU)2
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.
Time frame
Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU)Secondary outcomes
1
Opioid Consumption
Daily opioid use will be converted into oral morphine equivalent dose (mg/day) and compared across all follow-up points. The outcome evaluates the potential opioid-sparing effect of home-based interventional pain management.
Time frame
Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU)2
Functional Status
Functional capacity will be measured using the Barthel Index (0-100), comparing baseline scores with those at 1 week, 1 month, and at discharge.
Time frame
Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU)3
Patient and Family Satisfaction
Satisfaction with pain control and overall home-based care will be assessed using a 5-point Likert scale questionnaire at discharge and 1 month.
Time frame
Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU)4
Professional Perception of Feasibility
UHD professionals will complete a structured survey on the perceived feasibility, safety, and impact of interventional pain management at home after the first implementation phase.
Time frame
baseline and at completion of the implementation phase (approximately 1 month)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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