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Pain as Indication for Operative Treatment of Traumatic Rib Fractures

A Prospective Randomized Controlled Trial of Pain as Indication for Operative Treatment of Traumatic Rib Fractures.

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02094807
Acronym
potf
Enrollment
0
Registered
2014-03-24
Start date
2014-01-01
Completion date
2020-01-01
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Rib Fractures, Surgery, Trauma

Keywords

prospective study, surgical management, rib fractures, trauma

Brief 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.

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.

Interventions

DRUGNSAID

Will be used if other drugs are not tolerated.

Continous epidural anesthesia will be introduced by specialists in Anesthesia and Intensive care.

DRUGopioids

During firs 24 hours i.v will be used. Then slow releas tabletts will be preferred.

DRUGparacetamol

100mg x 4 i.v. during the first 24 hours. Then orally 100mg x 4.

PROCEDUREoperative fixation of rib fractures

Fractures will be stabilized on the outside of of the ribs.

Sponsors

Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults ≥18 years of age with traumatic rib fractures that meet the following 2 criteria: 1. A minimum of 4 rib fractures 2. Pain that requires analgesia in the form of opioids in equivalent doses of \> 25 mg iv morphine daily

Exclusion criteria

1. Concurrent spinal cord injuries with paralysis 2. Severe head injury where normal level of consciousness is not present 3. Severe neurological and musculoskeletal diseases that influence the function of the thoracic wall and lung volumes

Design outcomes

Primary

MeasureTime frameDescription
Pain: Visual Analogue Scale (VAS) (1-10)1 yearVisual Analogue Scale (VAS) (1-10; 1 better and 10 worse)

Secondary

MeasureTime frameDescription
time spent in hospital6 weeksLength of stay
EQ-5D-5L1 yearQuality of Life
Disability Rating Index (DRI)1 yearFunction and Activity

Countries

Sweden

Contacts

STUDY_DIRECTORHans Granhed, MD PhD

Sahlgrenska University Hospital

PRINCIPAL_INVESTIGATOREva-Corina Caragounis, MD

Sahlgrenska University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026