Pain Multidisciplinar Intervention in Major Trauma Patients

Pain Multidisciplinar Intervention Effect in Major Trauma Patients. Does it Improve the Quality of Life?

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Trauma; Psychological Trauma
• Intervention / Treatment: Drug: Paracetamol; Drug: Ibuprofen 600 mg; Drug: Tramadol; Drug: Morphine

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporacio Sanitaria Parc Tauli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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: Paracetamol; Routine clinical practice treatments recommended by the medical team involved; Other Names: Psychological drugs; Drug: Ibuprofen 600 mg; Routine clinical practice treatments recommended by the medical team involved; Other Names: Psychological drugs; Drug: Tramadol; Routine clinical practice treatments recommended by the medical team involved; Other Names: Psychological drugs; Drug: Morphine; Routine clinical practice treatments recommended by the medical team involved; Other Names: Psychological drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of treatments requiered	Type of treatments required (anti inflammatory, opioid, adjuvants, invasive procedures)	1 year
Number of visits requiered in chronic pain and psychologic specialists	Number of visits requiered in chronic pain and psychologic specialist	1 year
Type of pain according to EVA scale	Type and severity of pain according to EVA (visual pain scale: 0-10; no pain to lot of pain)	1 year

Collaborators and Investigators

• Sponsor: Nuria Llorach-Perucho
• Collaborators: Corporacion Parc Tauli
• Investigators: Study Director: Heura Llaquet-Bayo, MD, PhD, Corporación Parc Taulí; Principal Investigator: Nuria Llorach-Perucho, MD, Corporación Parc Taulí; Study Director: Salvador Navarro-Soto, MD, PhD, Corporación Parc Taulí

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Pain; Neurologic Manifestations; Mental Disorders; Stress Disorders, Traumatic; Psychological Trauma; Chronic Pain; Wounds and Injuries; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Analgesics, Opioid; Narcotics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Acetaminophen; Morphine; Tramadol; Ibuprofen
• Other Study ID Numbers: DOLOTRAU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No