NCT02094807

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• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sahlgrenska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Trauma
• Rib Fractures
• Surgery
• Pain

Interventions

Type	Name	Description
DRUG	NSAID	Will be used if other drugs are not tolerated.
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.
DRUG	paracetamol	100mg x 4 i.v. during the first 24 hours. Then orally 100mg x 4.
PROCEDURE	operative fixation of rib fractures	Fractures will be stabilized on the outside of of the ribs.

Timeline

• Start date: 2014-04-01
• Primary completion: 2020-05-01
• Completion: 2020-05-01
• First posted: 2014-03-24
• Last updated: 2018-07-12

Locations

1 site across 1 country: Sweden