Pain as Indication for Operative Treatment of Traumatic Rib Fractures (potf)

September 14, 2026 updated by: Eva-Corina Caragounis, Sahlgrenska University Hospital

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, 413 45
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Conservative management
Not operated. Thoracic epidural anesthesia will be used togeteher with paracetamol. If not sufficient opioids and NSAID will be added.
Drug: NSAID
Will be used if other drugs are not tolerated.
Other Names:
  • Voltaren
  • Diclofenac
  • Naprosyn
  • Tramadol
Procedure: thoracic epidural anesthesia
Continous epidural anesthesia will be introduced by specialists in Anesthesia and Intensive care.
Drug: opioids
During firs 24 hours i.v will be used. Then slow releas tabletts will be preferred.
Other Names:
  • Morfin
  • Oxycodone
  • Oxynorm
  • Oxycotin
Drug: paracetamol
100mg x 4 i.v. during the first 24 hours. Then orally 100mg x 4.
Other Names:
  • Panodil
  • Paracet
  • Alvedon
Active Comparator: Operative management
Operative fixation of rib fractures. Thoracic epidural anesthesia will be used togeteher with paracetamol. If not sufficient opioids and NSAID will be added.
Drug: NSAID
Will be used if other drugs are not tolerated.
Other Names:
  • Voltaren
  • Diclofenac
  • Naprosyn
  • Tramadol
Procedure: thoracic epidural anesthesia
Continous epidural anesthesia will be introduced by specialists in Anesthesia and Intensive care.
Drug: opioids
During firs 24 hours i.v will be used. Then slow releas tabletts will be preferred.
Other Names:
  • Morfin
  • Oxycodone
  • Oxynorm
  • Oxycotin
Drug: paracetamol
100mg x 4 i.v. during the first 24 hours. Then orally 100mg x 4.
Other Names:
  • Panodil
  • Paracet
  • Alvedon
Procedure: operative fixation of rib fractures
Fractures will be stabilized on the outside of of the ribs.
Other Names:
  • Matrix RIB Fixation Systems (De Puy Synthes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain: Visual Analogue Scale (VAS) (1-10)
Time Frame: 1 year
Visual Analogue Scale (VAS) (1-10; 1 better and 10 worse)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time spent in hospital
Time Frame: 6 weeks
Length of stay
6 weeks
EQ-5D-5L
Time Frame: 1 year
Quality of Life
1 year
Disability Rating Index (DRI)
Time Frame: 1 year
Function and Activity
1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The total cost
Time Frame: 1 year
Adding time spent in hospital, on ICU or high-care unit and time before return to work
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital

Collaborators

Sahlgrenska University Hospital, Sweden

Investigators

  • Study Director: Hans Granhed, MD PhD, Sahlgrenska University Hospital
  • Principal Investigator: Eva-Corina Caragounis, MD, Sahlgrenska University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2014

Primary Completion (Estimated)

January 1, 2020

Study Completion (Estimated)

January 1, 2020

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 21, 2014

First Posted (Estimated)

March 24, 2014

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • hg481115
  • epn887-13 (Registry Identifier: Ethical approval committe)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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