Pain as Indication for Operative Treatment of Traumatic Rib Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2020-05-31

Brief Summary

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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.

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Detailed Description

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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

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Trauma Rib Fractures Surgery Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conservative management

Not operated. Thoracic epidural anesthesia will be used togeteher with paracetamol. If not sufficient opioids and NSAID will be added.

Group Type OTHER

NSAID

Intervention Type DRUG

Will be used if other drugs are not tolerated.

thoracic epidural anesthesia

Intervention Type PROCEDURE

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

opioids

Intervention Type DRUG

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

paracetamol

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

NSAID

Intervention Type DRUG

Will be used if other drugs are not tolerated.

thoracic epidural anesthesia

Intervention Type PROCEDURE

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

opioids

Intervention Type DRUG

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

paracetamol

Intervention Type DRUG

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

operative fixation of rib fractures

Intervention Type PROCEDURE

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

Interventions

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NSAID

Will be used if other drugs are not tolerated.

Intervention Type DRUG

thoracic epidural anesthesia

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

Intervention Type PROCEDURE

opioids

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

Intervention Type DRUG

paracetamol

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

Intervention Type DRUG

operative fixation of rib fractures

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

Intervention Type PROCEDURE

Other Intervention Names

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Tramadol Voltaren Naprosyn Diclofenac Oxycotin Oxynorm Oxycodone Morfin Paracet Alvedon Panodil Matrix RIB Fixation Systems (De Puy Synthes)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No