Clinical trial · Observational
UDOPAL Study: Home-Based Interventional Approach to Pain Management in Home-Hospitalized Patients
UDOPAL Study: Hospital-at-Home Interventional Approach to Pain Management in Patients Receiving Home-Based Hospital Care
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Pain | — | UNRESOLVED | — |
| Chronic Pain | — | UNRESOLVED | — |
| Neuropathic Pain | — | UNRESOLVED | — |
| Palliative Care | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UDOPAL model | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- UDOPAL Cohort Description: Prospective observational cohort including patients admitted
- interventionNames
- Other: UDOPAL model
Primary outcomes (2)
- measure
- Change in Pain Intensity (Numeric Rating Scale, NRS 0-10)
- timeFrame
- Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU)
- description
- 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.
- measure
- Change in Pain Intensity (PAINAD 0-10 for patients with cognitive impairment)
- timeFrame
- Baseline (Day 0), 24 hours, 48 hours, 1 week, 1 month, and at discharge from the Home Hospitalization Unit (HHU)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Very limited life expectancy (estimated survival \<72 hours) or terminal/agonal condition. * Contraindication to interventional pain procedures, including: 1. Uncorrectable coagulopathy. 2. Systemic infection or local infection at the puncture site. 3. Documented allergy to any of the planned medications. 4. Tumor located in the infiltration area. 5. 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.
References
Publications (0)
Data not yet available