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

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• Status: Withdrawn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: Pain; Trauma; Surgery; Rib Fractures
• Intervention / Treatment: Drug: NSAID; Procedure: thoracic epidural anesthesia; Drug: opioids; Drug: paracetamol; Procedure: operative fixation of rib fractures

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

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

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: VAS (1-10)	VAS (1-10)	1 year

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sahlgren´s University Hospital
• Collaborators: Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2014
• Primary Completion (ANTICIPATED): May 1, 2020
• Study Completion (ANTICIPATED): May 1, 2020

Study Registration Dates

• First Submitted: March 18, 2014
• First Submitted That Met QC Criteria: March 21, 2014
• First Posted (ESTIMATE): March 24, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2018
• Last Update Submitted That Met QC Criteria: July 11, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: trauma; prospective study; rib fractures; surgical management
• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries; Fractures, Bone; Rib Fractures; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Diclofenac; Tramadol; Oxycodone
• Other Study ID Numbers: hg481115; epn887-13 (REGISTRY: Ethical approval committe)