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NCT Number: NCT02094807

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.

Why the study stopped: Slow inclusion rate. Awaiting results from NCT02132416.
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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

NSAID

Drug

Will be used if other drugs are not tolerated.

Other names: Tramadol, Voltaren, Naprosyn, Diclofenac

thoracic epidural anesthesia

Procedure

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

Opioids

Drug

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

Other names: Oxycotin, Oxynorm, Oxycodone, Morfin

Paracetamol

Drug

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

Other names: Paracet, Alvedon, Panodil

operative fixation of rib fractures

Procedure

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

Other names: Matrix RIB Fixation Systems (De Puy Synthes)

Primary outcomes

  1. Pain: Visual Analogue Scale (VAS) (1-10)

    Time frame: 1 year

    Visual Analogue Scale (VAS) (1-10; 1 better and 10 worse)

Secondary outcomes

  1. time spent in hospital

    Time frame: 6 weeks

    Length of stay

  2. EQ-5D-5L

    Time frame: 1 year

    Quality of Life

  3. Disability Rating Index (DRI)

    Time frame: 1 year

    Function and Activity

Other outcomes

  1. The total cost

    Time frame: 1 year

    Adding time spent in hospital, on ICU or high-care unit and time before return to work

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Acronym: potf

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Mar 24, 2014
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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