Pain Multidisciplinar Intervention in Major Trauma Patients

NCT05355441 | Completed

• 1 other identifier: DOLOTRAU
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Trauma; Chronic Pain; Psychological Trauma

Outcome Measures

Primary Outcomes (1)

• Perception of quality of life according to EQ-5D-5L questionnaire

  Perception of quality of life after multidisciplinar pain intervention according to European Quality of Life 5 Dimensions (EQ-5D-5L) questionnaire (0-100; poor health - good health)

  1 year

Secondary Outcomes (3)

• Type of pain according to EVA scale

  1 year

• Type of treatments requiered

  1 year

• Number of visits requiered in chronic pain and psychologic specialists

  1 year

Study Arms (1)

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: Paracetamol; Drug: Ibuprofen 600 mg; Drug: Tramadol; Drug: Morphine

Interventions

Paracetamol DRUG

Routine clinical practice treatments recommended by the medical team involved

Also known as: Psychological drugs

Multidisciplinar pain treatment patients

Ibuprofen 600 mg DRUG

Routine clinical practice treatments recommended by the medical team involved

Also known as: Psychological drugs

Multidisciplinar pain treatment patients

Tramadol DRUG

Routine clinical practice treatments recommended by the medical team involved

Also known as: Psychological drugs

Multidisciplinar pain treatment patients

Morphine DRUG

Routine clinical practice treatments recommended by the medical team involved

Also known as: Psychological drugs

Multidisciplinar pain treatment patients

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

Major trauma patients with moderate, severe or incapacitating pain after hospital discharge. Major trauma patients are defined as trauma patients that require an admission on the ICU.

You may qualify if:

• Major trauma patients with moderate, severe or incapacitating pain (according to EQ-5D-5L scale).

You may not qualify if:

• Death in the first 30 days after the trauma.
• Transferred to another center.

Sponsors & Collaborators

• Nuria Llorach-Perucho: lead
• Corporacion Parc Tauli: collaborator

Study Sites (1)

Corporació Sanitària Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

MeSH Terms

Conditions

Wounds and Injuries; Chronic Pain; Psychological Trauma

Interventions

Acetaminophen; Ibuprofen; Tramadol; Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Nuria Llorach-Perucho, MD

  Corporacion Parc Tauli

  PRINCIPAL INVESTIGATOR

• Salvador Navarro-Soto, MD, PhD

  Corporacion Parc Tauli

  STUDY DIRECTOR

• Heura Llaquet-Bayo, MD, PhD

  Corporacion Parc Tauli

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 2, 2022
• Study Start: April 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

ES (1)