NCT02094807

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

July 12, 2018

Status Verified

July 1, 2018

Enrollment Period

6.1 years

First QC Date

March 18, 2014

Last Update Submit

July 11, 2018

Conditions

TraumaRib FracturesSurgeryPain

Keywords

prospective studysurgical managementrib fracturestrauma

Outcome Measures

Primary Outcomes (1)

  • Pain: VAS (1-10)

    VAS (1-10)

    1 year

Secondary Outcomes (3)

  • time spent in hospital

    6 weeks

  • EQ-5D-5L

    1 year

  • DRI

    1 year

Other Outcomes (1)

  • The total cost

    1 year

Study Arms (2)

Conservative management

OTHER

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

Drug: NSAIDProcedure: thoracic epidural anesthesiaDrug: opioidsDrug: paracetamol

Operative management

ACTIVE COMPARATOR

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

Drug: NSAIDProcedure: thoracic epidural anesthesiaDrug: opioidsDrug: paracetamolProcedure: operative fixation of rib fractures

Interventions

NSAIDDRUG

Will be used if other drugs are not tolerated.

Also known as: Tramadol, Voltaren, Naprosyn, Diclofenac
Conservative managementOperative management
thoracic epidural anesthesiaPROCEDURE

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

Conservative managementOperative management
opioidsDRUG

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

Also known as: Oxycotin, Oxynorm, Oxycodone, Morfin
Conservative managementOperative management
paracetamolDRUG

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

Also known as: Paracet, Alvedon, Panodil
Conservative managementOperative management
operative fixation of rib fracturesPROCEDURE

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

Also known as: Matrix RIB Fixation Systems (De Puy Synthes)
Operative management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

MeSH Terms

Conditions

Wounds and InjuriesRib FracturesPain

Interventions

Anti-Inflammatory Agents, Non-SteroidalTramadolDiclofenacNaproxenAnalgesics, OpioidOxycodoneAcetaminophen

Condition Hierarchy (Ancestors)

Fractures, BoneThoracic InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic AgentsCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsPhenylacetatesAcids, CarbocyclicCarboxylic AcidsNaphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsNarcoticsCentral Nervous System DepressantsCentral Nervous System AgentsCodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesAcetanilidesAnilidesAmidesAniline Compounds

Study Officials

  • Hans Granhed, MD PhD

    Sahlgrenska University Hospital

    STUDY DIRECTOR

  • Eva-Corina Caragounis, MD

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 18, 2014

First Posted

March 24, 2014

Study Start

April 1, 2014

Primary Completion

May 1, 2020

Study Completion

May 1, 2020

Last Updated

July 12, 2018

Record last verified: 2018-07

Locations

SE(1)