Pain as Indication for Operative Treatment of Traumatic Rib Fractures

Pain Clinical Trial

— potf  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02094807
• Other study ID #: hg481115
• Secondary ID: epn887-13
• Status: Withdrawn
• Phase: N/A
• Start date: April 2014
• Est. completion date: May 2020

Study information

• Verified date: July 2018
• Source: Sahlgren´s University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Pain
• Rib Fractures
• Surgery
• Trauma

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg

Sponsors (2)

Lead Sponsor	Collaborator
Sahlgren´s University Hospital	Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The total cost	Adding time spent in hospital, on ICU or high-care unit and time before return to work	1 year
Primary	Pain: VAS (1-10)	VAS (1-10)	1 year
Secondary	time spent in hospital	Length of stay	6 weeks
Secondary	EQ-5D-5L	Quality of Life	1 year
Secondary	DRI	Function and Activity	1 year