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

Primary Purpose

Trauma, Rib Fractures, Surgery

Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
NSAID
thoracic epidural anesthesia
opioids
paracetamol
operative fixation of rib fractures
Sponsored by
Sahlgren´s University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trauma focused on measuring prospective study, surgical management, rib fractures, trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Conservative management

Operative management

Arm Description

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

Operative fixation of rib fractures. Thoracic epidural anesthesia will be used togeteher with paracetamol. If not sufficient opioids and NSAID will be added.

Outcomes

Primary Outcome Measures

Pain: VAS (1-10)
VAS (1-10)

Secondary Outcome Measures

time spent in hospital
Length of stay
EQ-5D-5L
Quality of Life
DRI
Function and Activity

Full Information

First Posted
March 18, 2014
Last Updated
July 11, 2018
Sponsor
Sahlgren´s University Hospital
Collaborators
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02094807
Brief Title
Pain as Indication for Operative Treatment of Traumatic Rib Fractures
Acronym
potf
Official Title
A Prospective Randomized Controlled Trial of Pain as Indication for Operative Treatment of Traumatic Rib Fractures.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Slow inclusion rate. Awaiting results from NCT02132416.
Study Start Date
April 2014 (Actual)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgren´s University Hospital
Collaborators
Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Rib Fractures, Surgery, Pain
Keywords
prospective study, surgical management, rib fractures, trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conservative management
Arm Type
Other
Arm Description
Not operated. Thoracic epidural anesthesia will be used togeteher with paracetamol. If not sufficient opioids and NSAID will be added.
Arm Title
Operative management
Arm Type
Active Comparator
Arm Description
Operative fixation of rib fractures. Thoracic epidural anesthesia will be used togeteher with paracetamol. If not sufficient opioids and NSAID will be added.
Intervention Type
Drug
Intervention Name(s)
NSAID
Other Intervention Name(s)
Tramadol, Voltaren, Naprosyn, Diclofenac
Intervention Description
Will be used if other drugs are not tolerated.
Intervention Type
Procedure
Intervention Name(s)
thoracic epidural anesthesia
Intervention Description
Continous epidural anesthesia will be introduced by specialists in Anesthesia and Intensive care.
Intervention Type
Drug
Intervention Name(s)
opioids
Other Intervention Name(s)
Oxycotin, Oxynorm, Oxycodone, Morfin
Intervention Description
During firs 24 hours i.v will be used. Then slow releas tabletts will be preferred.
Intervention Type
Drug
Intervention Name(s)
paracetamol
Other Intervention Name(s)
Paracet, Alvedon, Panodil
Intervention Description
100mg x 4 i.v. during the first 24 hours. Then orally 100mg x 4.
Intervention Type
Procedure
Intervention Name(s)
operative fixation of rib fractures
Other Intervention Name(s)
Matrix RIB Fixation Systems (De Puy Synthes)
Intervention Description
Fractures will be stabilized on the outside of of the ribs.
Primary Outcome Measure Information:
Title
Pain: VAS (1-10)
Description
VAS (1-10)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
time spent in hospital
Description
Length of stay
Time Frame
6 weeks
Title
EQ-5D-5L
Description
Quality of Life
Time Frame
1 year
Title
DRI
Description
Function and Activity
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
The total cost
Description
Adding time spent in hospital, on ICU or high-care unit and time before return to work
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults ≥18 years of age with traumatic rib fractures that meet the following 2 criteria: A minimum of 4 rib fractures Pain that requires analgesia in the form of opioids in equivalent doses of > 25 mg iv morphine daily Exclusion Criteria: Concurrent spinal cord injuries with paralysis Severe head injury where normal level of consciousness is not present Severe neurological and musculoskeletal diseases that influence the function of the thoracic wall and lung volumes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Granhed, MD PhD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eva-Corina Caragounis, MD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden

12. IPD Sharing Statement

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Pain as Indication for Operative Treatment of Traumatic Rib Fractures

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