TraumaNCT05355441
Pain Multidisciplinar Intervention in Major Trauma Patients
An observational study of Trauma and Chronic Pain, run by Nuria Llorach-Perucho at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Chronic Pain, Psychological Trauma
- What is being tested?
- Paracetamol, Ibuprofen 600 mg and Tramadol
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2022to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Major trauma patients with moderate, severe or incapacitating pain (according to EQ-5D-5L scale).
Who cannot join
- Death in the first 30 days after the trauma.
- Transferred to another center.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Trauma, Chronic Pain, Psychological Trauma
- Being tested
- Paracetamol, Ibuprofen 600 mg, Tramadol, Morphine
- Medical subject headings
- Wounds and Injuries, Chronic Pain, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Psychological drugs
Routine clinical practice treatments recommended by the medical team involved
Ibuprofen 600 mgDrug
Also called Psychological drugs
Routine clinical practice treatments recommended by the medical team involved
TramadolDrug
Also called Psychological drugs
Routine clinical practice treatments recommended by the medical team involved
MorphineDrug
Also called Psychological drugs
Routine clinical practice treatments recommended by the medical team involved
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Paracetamol; Drug: Ibuprofen 600 mg; Drug: Tramadol; Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (3)
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)
Measured: 1 year
Type of treatments requiered
Type of treatments required (anti inflammatory, opioid, adjuvants, invasive procedures)
Measured: 1 year
Number of visits requiered in chronic pain and psychologic specialists
Number of visits requiered in chronic pain and psychologic specialist
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start1 Apr 2022
- Primary completion1 Apr 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuria Llorach-Perucho
- Sponsor type
- University, hospital or other
- Collaborators
- Corporacion Parc Tauli
- Responsible party
- Sponsor-investigator, Nuria Llorach-Perucho, Corporacion Parc Tauli
- Investigators
- Nuria Llorach-Perucho, MD, Principal investigator, Corporacion Parc TauliSalvador Navarro-Soto, MD, PhD, Study director, Corporacion Parc TauliHeura Llaquet-Bayo, MD, PhD, Study director, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355441
- Sponsor's protocol ID
- DOLOTRAU
- Status last verified
- Feb 2025
- First submitted
- 21 Apr 2022
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Multidisciplinar Intervention Effect in Major Trauma Patients. Does it Improve the Quality of Life?
- ClinicalTrials.gov ID
- NCT05355441
- Acronym / sponsor ID
- DOLOTRAU
- Conditions
- Trauma, Chronic Pain, Psychological Trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Nuria Llorach-PeruchoUniversity, hospital or other
- Collaborators
- Corporacion Parc Tauli
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinar pain treatment patients | – | Drug: Paracetamol, Drug: Ibuprofen 600 mg, Drug: Tramadol, Drug: MorphineMajor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Major trauma patients with moderate, severe or incapacitating pain (according to EQ-5D-5L scale).
Key exclusion criteria (2 listed)
- Death in the first 30 days after the trauma.
- Transferred to another center.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolAlso: Psychological drugsRoutine clinical practice treatments recommended by the medical team involved | Drug | Multidisciplinar pain treatment patients |
| Ibuprofen 600 mgAlso: Psychological drugsRoutine clinical practice treatments recommended by the medical team involved | Drug | Multidisciplinar pain treatment patients |
| TramadolAlso: Psychological drugsRoutine clinical practice treatments recommended by the medical team involved | Drug | Multidisciplinar pain treatment patients |
| MorphineAlso: Psychological drugsRoutine clinical practice treatments recommended by the medical team involved | Drug | Multidisciplinar pain treatment patients |
Primary outcome
Perception of quality of life according to EQ-5D-5L questionnaire
Time frame: 1 year
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)
3 secondary outcomes
Type of pain according to EVA scale
Time frame: 1 year
Type of treatments requiered
Time frame: 1 year
Number of visits requiered in chronic pain and psychologic specialists
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuria Llorach-Perucho, MD principal investigator
Corporacion Parc Tauli
Salvador Navarro-Soto, MD, PhD study director
Corporacion Parc Tauli
Heura Llaquet-Bayo, MD, PhD study director
Corporacion Parc Tauli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Chronic Pain, run by Nuria Llorach-Perucho at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of quality of life according to EQ-5D-5L questionnaire (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.