TraumapotfNCT02094807
Pain as Indication for Operative Treatment of Traumatic Rib Fractures
A study testing NSAID, thoracic epidural anesthesia and opioids in people with Trauma and Rib Fractures, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
The purpose of this prospective randomized controlled study is to determine whether acute and chronic pain in patients who suffer multiple traumatic rib fractures is decreased after surgical management as compared to conservative management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Rib Fractures, Surgery
- What is being tested?
- NSAID, thoracic epidural anesthesia and opioids
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2014to Jan 2020
- Phase
- Interventional
- 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
Who may be able to join
- Adults ≥18 years of age with traumatic rib fractures that meet the following 2 criteria:
- A minimum of 4 rib fractures
- Pain that requires analgesia in the form of opioids in equivalent doses of > 25 mg iv morphine daily
Who cannot join
- Concurrent spinal cord injuries with paralysis
- Severe head injury where normal level of consciousness is not present
- Severe neurological and musculoskeletal diseases that influence the function of the thoracic wall and lung volumes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Trial of Pain as Indication for Operative Treatment of Traumatic Rib Fractures.
The purpose of this prospective randomized controlled study is to determine whether acute and chronic pain in patients who suffer multiple traumatic rib fractures is decreased after surgical management as compared to conservative management.
Read the detailed description
Patients meeting the inclusion criteria and giving their informed consent will be enrolled in this prospective randomized controlled study. In total 60 patients will be randomized to either surgical or conservative management of rib fractures. 3D reconstructions of computed tomography images of the Thorax done at admission to hospital will be used in order to evaluate injury according to Lung Injury Scale and Chest wall Injury Scale and for calculating radiological lung volumes and plan surgical procedure in the intervention group. Surgery will be performed as soon as possible after randomization. MatrixRIB® (DePuy Synthes) Fixation system is used for stabilizing rib fractures with plates and angular locked screws. Unless there is a medical indication or the patient has a chest tube pre-operatively, thoracotomy will be avoided. In cases where thoracotomy is done the patients will receive an anterior and posterior chest tube and wound drain with active suction. All patients, both in the intervention and in the control group will be offered thoracic epidural anaesthesia. Broad-spectrum antibiotic therapy iv is given as long as the patient has chest tubes. Thrombotic prophylaxis with LMWH is given until the patient is mobilized but for a minimum of 7 days. Patients will be followed-up 6 weeks, 6 months and 1 year post-operatively by surgeon and physiotherapist. A low-dosage computer tomography of the thorax will be done after 6 months in order to evaluate healing of the rib cage, possible non-union or dysfunction of osteosynthetic material and measure remaining lung volume. This examination will be compared to the initial computer tomography image done when the patient was admitted. At follow-ups complaints, possible late complications, usage of analgesia and return to work will be recorded. Evaluated instruments, EQ-5D-5L, VAS with Pain-O-Meter (POM) and Disability Rating Index (DRI) will be used to evaluate quality of life, pain and physical function. Range of motion in the thorax, thoracic spine and shoulders will be evaluated for every patient. Breathing movements will be measured by using a Respiratory movement measuring instrument (RMMI, ReMo Inc) and lung function tests will be performed in a standardized manner.
- Conditions
- Trauma, Rib Fractures, Surgery, Pain
- Being tested
- NSAID, thoracic epidural anesthesia, opioids, paracetamol, operative fixation of rib fractures
- Keywords
- prospective study, surgical management, rib fractures, trauma
- Medical subject headings
- Wounds and Injuries, Rib Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NSAIDDrug
Also called Tramadol, Voltaren, Naprosyn, Diclofenac
Will be used if other drugs are not tolerated.
thoracic epidural anesthesiaProcedure or surgery
Continous epidural anesthesia will be introduced by specialists in Anesthesia and Intensive care.
opioidsDrug
Also called Oxycotin, Oxynorm, Oxycodone, Morfin
During firs 24 hours i.v will be used. Then slow releas tabletts will be preferred.
paracetamolDrug
Also called Paracet, Alvedon, Panodil
100mg x 4 i.v. during the first 24 hours. Then orally 100mg x 4.
operative fixation of rib fracturesProcedure or surgery
Also called Matrix RIB Fixation Systems (De Puy Synthes)
Fractures will be stabilized on the outside of of the ribs.
| Study group | Role | What they receive |
|---|---|---|
| Conservative management | Other | Not operated. Thoracic epidural anesthesia will be used togeteher with paracetamol. If not sufficient opioids and NSAID will be added. Receives: Drug: NSAID; Procedure: thoracic epidural anesthesia; Drug: opioids; Drug: paracetamol |
| Operative management | Active comparator | Operative fixation of rib fractures. Thoracic epidural anesthesia will be used togeteher with paracetamol. If not sufficient opioids and NSAID will be added. Receives: Drug: NSAID; Procedure: thoracic epidural anesthesia; Drug: opioids; Drug: paracetamol; Procedure: operative fixation of rib fractures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain: Visual Analogue Scale (VAS) (1-10)
Visual Analogue Scale (VAS) (1-10; 1 better and 10 worse)
Measured: 1 year
Secondary outcomes (3)
time spent in hospital
Length of stay
Measured: 6 weeks
EQ-5D-5L
Quality of Life
Measured: 1 year
Disability Rating Index (DRI)
Function and Activity
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 posted24 Mar 2014 (estimated)
- Study startJan 2014 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: Slow inclusion rate. Awaiting results from NCT02132416.
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.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva-Corina Caragounis, Sahlgrenska University Hospital
- Investigators
- Hans Granhed, MD PhD, Study director, Sahlgrenska University HospitalEva-Corina Caragounis, MD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02094807
- Sponsor's protocol ID
- hg481115
- Other IDs
- epn887-13
- Acronym
- potf
- Status last verified
- May 2024
- First submitted
- 18 Mar 2014
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of Pain as Indication for Operative Treatment of Traumatic Rib Fractures.
- ClinicalTrials.gov ID
- NCT02094807
- Acronym / sponsor ID
- potf / hg481115
- Conditions
- Trauma, Rib Fractures, Surgery, Pain
- Keywords
- prospective study, surgical management, rib fractures, trauma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Slow inclusion rate. Awaiting results from NCT02132416.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Jan 2014 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 24 Mar 2014 (estimated)
- 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.
The purpose of this prospective randomized controlled study is to determine whether acute and chronic pain in patients who suffer multiple traumatic rib fractures is decreased after surgical management as compared to conservative management.
Detailed description
Patients meeting the inclusion criteria and giving their informed consent will be enrolled in this prospective randomized controlled study. In total 60 patients will be randomized to either surgical or conservative management of rib fractures. 3D reconstructions of computed tomography images of the Thorax done at admission to hospital will be used in order to evaluate injury according to Lung Injury Scale and Chest wall Injury Scale and for calculating radiological lung volumes and plan surgical procedure in the intervention group. Surgery will be performed as soon as possible after randomization. MatrixRIB® (DePuy Synthes) Fixation system is used for stabilizing rib fractures with plates and angular locked screws. Unless there is a medical indication or the patient has a chest tube pre-operatively, thoracotomy will be avoided. In cases where thoracotomy is done the patients will receive an anterior and posterior chest tube and wound drain with active suction. All patients, both in the intervention and in the control group will be offered thoracic epidural anaesthesia. Broad-spectrum antibiotic therapy iv is given as long as the patient has chest tubes. Thrombotic prophylaxis with LMWH is given until the patient is mobilized but for a minimum of 7 days. Patients will be followed-up 6 weeks, 6 months and 1 year post-operatively by surgeon and physiotherapist. A low-dosage computer tomography of the thorax will be done after 6 months in order to evaluate healing of the rib cage, possible non-union or dysfunction of osteosynthetic material and measure remaining lung volume. This examination will be compared to the initial computer tomography image done when the patient was admitted. At follow-ups complaints, possible late complications, usage of analgesia and return to work will be recorded. Evaluated instruments, EQ-5D-5L, VAS with Pain-O-Meter (POM) and Disability Rating Index (DRI) will be used to evaluate quality of life, pain and physical function. Range of motion in the thorax, thoracic spine and shoulders will be evaluated for every patient. Breathing movements will be measured by using a Respiratory movement measuring instrument (RMMI, ReMo Inc) and lung function tests will be performed in a standardized manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative management | Other | Drug: NSAID, Procedure: thoracic epidural anesthesia, Drug: opioids, Drug: paracetamolNot operated. Thoracic epidural anesthesia will be used togeteher with paracetamol. If not sufficient opioids and NSAID will be added. |
| Operative management | Active comparator | Drug: NSAID, Procedure: thoracic epidural anesthesia, Drug: opioids, Drug: paracetamol, Procedure: operative fixation of rib fracturesOperative fixation of rib fractures. Thoracic epidural anesthesia will be used togeteher with paracetamol. If not sufficient opioids and NSAID will be added. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A minimum of 4 rib fractures
- Pain that requires analgesia in the form of opioids in equivalent doses of > 25 mg iv morphine daily
Key exclusion criteria (3 listed)
- Concurrent spinal cord injuries with paralysis
- Severe head injury where normal level of consciousness is not present
- Severe neurological and musculoskeletal diseases that influence the function of the thoracic wall and lung volumes
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 |
|---|---|---|
| NSAIDAlso: Tramadol, Voltaren, Naprosyn, DiclofenacWill be used if other drugs are not tolerated. | Drug | Conservative management, Operative management |
| thoracic epidural anesthesiaContinous epidural anesthesia will be introduced by specialists in Anesthesia and Intensive care. | Procedure or surgery | Conservative management, Operative management |
| opioidsAlso: Oxycotin, Oxynorm, Oxycodone, MorfinDuring firs 24 hours i.v will be used. Then slow releas tabletts will be preferred. | Drug | Conservative management, Operative management |
| paracetamolAlso: Paracet, Alvedon, Panodil100mg x 4 i.v. during the first 24 hours. Then orally 100mg x 4. | Drug | Conservative management, Operative management |
| operative fixation of rib fracturesAlso: Matrix RIB Fixation Systems (De Puy Synthes)Fractures will be stabilized on the outside of of the ribs. | Procedure or surgery | Operative management |
Primary outcome
Pain: Visual Analogue Scale (VAS) (1-10)
Time frame: 1 year
Visual Analogue Scale (VAS) (1-10; 1 better and 10 worse)
3 secondary outcomes
time spent in hospital
Time frame: 6 weeks
EQ-5D-5L
Time frame: 1 year
Disability Rating Index (DRI)
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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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.
Hans Granhed, MD PhD study director
Sahlgrenska University Hospital
Eva-Corina Caragounis, MD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NSAID, thoracic epidural anesthesia and opioids in people with Trauma and Rib Fractures, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 17 Sep 2026. 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 Sweden. 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 was withdrawn before enrolling participants, so there are no results.
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?
Pain: Visual Analogue Scale (VAS) (1-10) (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 17 Sep 2026.