Randomized Clinical Trial of Rib Fixation Versus Medical Analgesia in Uncomplicated Rib Fractures on Pain Control.

NCT04745520 | Terminated DMC

• 1 other identifier: 2019-01688
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Uncomplicated costal fractures often result in persistent pain over the long term. Indeed, cohort studies showed that at 6 months, 22% of patients still had pain and 56% had functional disability. The impact of costal fractures on quality of life is underestimated. The socio-psycho-economic consequences are substantial. Previous studies have shown that an important factor for persistent pain and functional disability is the intensity of the initial pain. However, preliminary studies have shown promising results with surgical fixation of rib fractures: reduced need for analgesic drugs, reduced pain at 1 month, reduced complications and improved motor skills in patients over 65 years of age. To date, the only clinical trials that exist focused on the fixation of complicated rib dislocations. While fixation of uncomplicated rib fractures is a common practice, no randomized studies have been conducted to evaluate its impact on pain and quality of life in the medium and long term. In this context, the aim of our randomized study is to compare pain at 2 months between operated and non-operated patients with uncomplicated rib fractures.

Conditions

Rib Fractures

Keywords

thoracic trauma; rib fixation; medical device

Outcome Measures

Primary Outcomes (1)

• Pain severity

  Pain level reported by the participant, as assessed via the first part of the French version of the brief pain inventory (BPI) questionnaire. 0-10 scale. 10 indicating worst pain

  Two months after injury

Secondary Outcomes (41)

• Pain severity

  At recruitment (baseline)

• Pain severity

  One month after injury

• Pain severity

  Three months after injury

• Pain severity

  Six months after injury

• Pain severity

  Twelve months after injury

Study Arms (2)

Rib fixation (medical devices)

EXPERIMENTAL

Surgery and pain medication. The pain of patients will be treated with rib fixation and pain medication.

Device: Rib fixation; Drug: Analgesia

Pain medication (comparator treatment)

ACTIVE COMPARATOR

Pain medication only.

Drug: Analgesia

Interventions

Rib fixation DEVICE

Rib fixation is performed by a senior surgeon. The patient is under general anesthesia. A thoracotomy focused on the fracture is performed to optimize access to the rib to be repaired. Video-assisted thoracic surgery (VATS) can be performed to better localize rib fractures. Significant muscle division is avoided. Removal of the periosteum is not required. The broken rib segments are approximated with forceps and the medical devices are used to fix the fracture. The medical devices are implemented according to the manufacturers' recommendations. The goal is to stabilize the chest wall. It is not useful to fix all fractures to stabilize the wall. A chest tube can be placed at the end of the operation. Medical devices The following medical devices can be used: * MatrixRIB™, De Puy Synthes Companies, Zuchwill, Switzerland * STRATOS™, MedXpert GmbH, Heitersheim, Germany * NiTi Fixing PlatesTM, IAWAI, Yandzhou, China

Rib fixation (medical devices)

Analgesia DRUG

Epidural analgesia is continuing for 24 to 72 hours post-randomization to maximize outcome benefits. Afterwards, paracetamol, NSAID and/or opioid treatment are used according to pain severity. In case of opioid use, morphine treatment is preferred. However, other opioid drugs or doses can be considered to better customize the treatment.

Pain medication (comparator treatment); Rib fixation (medical devices)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 2 rib fractures
• At least 1 dislocated rib fracture
• Fractures accessible to surgery
• Thoracic epidural analgesia
• Written informed consent

You may not qualify if:

• Any other concomitant fractures excepted clavicle fracture
• Respiratory distress syndrome according to the Berlin definition
• Presence of \>1.5 liter of blood drained from the pleural space
• Hemostasis disorder defined by any of the following criteria:
• Platelet count \< 70'000/mm3,
• International Normalized Ratio (INR) \> 1.2 (Prothrombin \< 70%)
• activated partial thromboplastin time (aPTT) ≥ 60 seconds
• drugs such as: P2Y12 antagonists (clopidogrel, prasugrel) and glycoprotein IIb/IIIa antagonists (abciximab, tirofiban)
• Pathological rib fracture due to metastasis
• Hemodynamic instability: systolic blood pressure \< 100 mmHg and heart rate \> 100 beats per minute
• Neurologic disorder: Glasgow Coma Score \< 13 in the initial 24 hours, or intracerebral, epidural, subdural, or subarachnoid hemorrhages, or cerebral contusion
• Titanium allergy
• Known or suspected non-compliance to medical therapy due to drug or alcohol abuse
• Age \<18 years old
• Women who know they are pregnant or breast feeding

Sponsors & Collaborators

• Benoît Bédat: lead
• Centre Hospitalier Universitaire Vaudois: collaborator
• Hôpital du Valais: collaborator

Study Sites (1)

Unit of Thoracic and Endocrine Surgery, University Hospitals of Geneva

Geneva, 1205, Switzerland

Location

Related Publications (10)

• Kerr-Valentic MA, Arthur M, Mullins RJ, Pearson TE, Mayberry JC. Rib fracture pain and disability: can we do better? J Trauma. 2003 Jun;54(6):1058-63; discussion 1063-4. doi: 10.1097/01.TA.0000060262.76267.EF.

  PMID: 12813323 BACKGROUND

• Fabricant L, Ham B, Mullins R, Mayberry J. Prolonged pain and disability are common after rib fractures. Am J Surg. 2013 May;205(5):511-5; discusssion 515-6. doi: 10.1016/j.amjsurg.2012.12.007.

  PMID: 23592156 BACKGROUND

• Gordy S, Fabricant L, Ham B, Mullins R, Mayberry J. The contribution of rib fractures to chronic pain and disability. Am J Surg. 2014 May;207(5):659-62; discussion 662-3. doi: 10.1016/j.amjsurg.2013.12.012. Epub 2014 Jan 31.

  PMID: 24612969 BACKGROUND

• Marasco S, Lee G, Summerhayes R, Fitzgerald M, Bailey M. Quality of life after major trauma with multiple rib fractures. Injury. 2015 Jan;46(1):61-5. doi: 10.1016/j.injury.2014.06.014. Epub 2014 Jun 21.

  PMID: 25069400 BACKGROUND

• Katz J, Jackson M, Kavanagh BP, Sandler AN. Acute pain after thoracic surgery predicts long-term post-thoracotomy pain. Clin J Pain. 1996 Mar;12(1):50-5. doi: 10.1097/00002508-199603000-00009.

  PMID: 8722735 BACKGROUND

• de Moya M, Bramos T, Agarwal S, Fikry K, Janjua S, King DR, Alam HB, Velmahos GC, Burke P, Tobler W. Pain as an indication for rib fixation: a bi-institutional pilot study. J Trauma. 2011 Dec;71(6):1750-4. doi: 10.1097/TA.0b013e31823c85e9.

  PMID: 22182884 BACKGROUND

• Wu WM, Yang Y, Gao ZL, Zhao TC, He WW. Which is better to multiple rib fractures, surgical treatment or conservative treatment? Int J Clin Exp Med. 2015 May 15;8(5):7930-6. eCollection 2015.

  PMID: 26221350 BACKGROUND

• Fitzgerald MT, Ashley DW, Abukhdeir H, Christie DB 3rd. Rib fracture fixation in the 65 years and older population: A paradigm shift in management strategy at a Level I trauma center. J Trauma Acute Care Surg. 2017 Mar;82(3):524-527. doi: 10.1097/TA.0000000000001330.

  PMID: 28030506 BACKGROUND

• Peek J, Smeeing DPJ, Hietbrink F, Houwert RM, Marsman M, de Jong MB. Comparison of analgesic interventions for traumatic rib fractures: a systematic review and meta-analysis. Eur J Trauma Emerg Surg. 2019 Aug;45(4):597-622. doi: 10.1007/s00068-018-0918-7. Epub 2018 Feb 6.

  PMID: 29411048 BACKGROUND

• Perentes JY, Christodoulou M, Abdelnour-Berchtold E, Karenovics W, Gayet-Ageron A, Gonzalez M, Krueger T, Triponez F, Terrier P, Bedat B. Effectiveness of rib fixation compared to pain medication alone on pain control in patients with uncomplicated rib fractures: study protocol of a pragmatic multicenter randomized controlled trial-the PAROS study (Pain After Rib OSteosynthesis). Trials. 2022 Sep 2;23(1):732. doi: 10.1186/s13063-022-06509-0.

  PMID: 36056421 DERIVED

MeSH Terms

Conditions

Rib Fractures

Interventions

Analgesia

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Benoît Bédat, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

• Frédéric Triponez, Prof.

  University Hospital, Geneva

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: it is not possible to blind the patients and investigators regarding surgery.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Fellow

Model Details: This pragmatic trial is a multi-center, two-arm, parallel-group, superiority randomized-controlled trial.

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: February 9, 2021
• Study Start: March 12, 2021
• Primary Completion: November 16, 2023
• Study Completion: September 16, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)