Pain Multidisciplinar Intervention in Major Trauma Patients

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05355441
• Other study ID #: DOLOTRAU
• Status: Recruiting
• Start date: April 1, 2022
• Est. completion date: November 1, 2024

Study information

• Verified date: February 2024
• Source: Corporacion Parc Tauli
• Contact: Nuria Llorach-Perucho, MD
• Phone: 0034656336708
• Email: nuriallorachperucho[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Psychological Trauma
• Trauma
• Wounds and Injuries

Intervention

Drug:
• Paracetamol
Routine clinical practice treatments recommended by the medical team involved
• Ibuprofen 600 mg
Routine clinical practice treatments recommended by the medical team involved
• Tramadol
Routine clinical practice treatments recommended by the medical team involved
• Morphine
Routine clinical practice treatments recommended by the medical team involved

Locations

Country	Name	City	State
Spain	Corporació Sanitària Parc Taulí	Sabadell	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Nuria Llorach-Perucho	Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Type of treatments requiered	Type of treatments required (anti inflammatory, opioid, adjuvants, invasive procedures)	1 year
Secondary	Number of visits requiered in chronic pain and psychologic specialists	Number of visits requiered in chronic pain and psychologic specialist	1 year