NCT04745520: PAROS

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

Terminated NA Last updated 20 January 2025

What this trial tests

NA trial testing Rib fixation in Rib Fractures in 102 participants. Terminated before completion.

Timeline

12 March 2021

Primary endpoint
16 November 2023

16 September 2024

Quick facts

Lead sponsor	Benoît Bédat
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	102
Start date	12 March 2021
Primary completion	16 November 2023
Estimated completion	16 September 2024
Sites	1 location across Switzerland

Drugs / interventions tested

• Rib fixation
• Analgesia — full drug profile →

Conditions studied

• Rib Fractures — all drugs for Rib Fractures →

Sponsor

Benoît Bédat

Who can join

18 and older, any sex, with Rib Fractures. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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).
   Perentes JY, Christodoulou M, Abdelnour-Berchtold E, Karenovics W, et al · · 2022 · cited 4× · PMID 36056421 · DOI 10.1186/s13063-022-06509-0