Pain Multidisciplinar Intervention in Major Trauma Patients

Sponsor
Nuria Llorach-Perucho (Other)
Overall Status
Recruiting
CT.gov ID
NCT05355441
Collaborator
Corporacion Parc Tauli (Other)
80
1
31
2.6

Study Details

Study Description

Brief Summary

In Spain, major trauma continues to be the leading cause of death among young people. However, mortality rates represent only a relatively small part of the impact of trauma injuries on the health of the population. Pain and anxiety are two of the most poorly controlled factors that have a huge impact on a patient's quality of life.The type of therapy that has been shown to be most effective in treating post-traumatic pain is one that involves different specialists, given its multicausality, care should be multidisciplinary.

This investigation project consists in an observational study performed by a multidisciplinary team in our center. Major trauma patients with moderate, severe or incapacitating pain will be referred to consultations specialized in chronic pain and psychology. One year after the trauma, patients will be evaluated in terms of quality of life.

The aim of this study is to determinate the impact that multidisciplinary treatment of post-traumatic pain has on the perception of quality of life in severely injured patients.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pain Multidisciplinar Intervention Effect in Major Trauma Patients. Does it Improve the Quality of Life?
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Multidisciplinar pain treatment patients

Major trauma patients with moderate, severe or incapacitating pain will be referred to consultation specialized in chronic pain and psychology. Patients will be evaluated, in terms of quality of life, before and after the treatment.

Drug: Analgesic
Routine clinical practice treatments recommended by the medical team involved
Other Names:
  • Psychological drugs
  • Outcome Measures

    Primary Outcome Measures

    1. Perception of quality of life according to EQ-5D-5L questionnaire [1 year]

      Perception of quality of life after multidisciplinar pain intervention according to EQ-5D-5L questionnaire

    Secondary Outcome Measures

    1. Type of pain according to EVA scale [1 year]

      Type and severity of pain according to EVA (visual pain scale)

    2. Type of treatments requiered [1 year]

      Type of treatments required (anti inflammatory, opioid, adjuvants, invasive procedures)

    3. Number of visits requiered in chronic pain and psychologic specialists [1 year]

      Number of visits requiered in chronic pain and psychologic specialist

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Major trauma patients with moderate, severe or incapacitating pain (according to EQ-5D-5L scale).
    Exclusion Criteria:
    • Death in the first 30 days after the trauma.

    • Transferred to another center.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Corporació Sanitària Parc Taulí Sabadell Barcelona Spain 08208

    Sponsors and Collaborators

    • Nuria Llorach-Perucho
    • Corporacion Parc Tauli

    Investigators

    • Principal Investigator: Nuria Llorach-Perucho, MD, Corporacion Parc Tauli
    • Study Director: Salvador Navarro-Soto, MD, PhD, Corporacion Parc Tauli
    • Study Director: Heura Llaquet-Bayo, MD, PhD, Corporacion Parc Tauli

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nuria Llorach-Perucho, Principal Investigator, Corporacion Parc Tauli
    ClinicalTrials.gov Identifier:
    NCT05355441
    Other Study ID Numbers:
    • DOLOTRAU
    First Posted:
    May 2, 2022
    Last Update Posted:
    May 2, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 2, 2022