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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Rib Fracture | Study protocol

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)

Authors: Jean Yaniss Perentes, Michel Christodoulou, Etienne Abdelnour-Berchtold, Wolfram Karenovics, Angèle Gayet-Ageron, Michel Gonzalez, Thorsten Krueger, Frédéric Triponez, Philippe Terrier, Benoît Bédat

Published in: Trials | Issue 1/2022

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Abstract

Background

Persistent pain and disability following rib fractures result in a large psycho-socio-economic impact for health-care system. Benefits of rib osteosynthesis are well documented in patients with flail chest that necessitates invasive ventilation. In patients with uncomplicated and simple rib fractures, indication for rib osteosynthesis is not clear. The aim of this trial is to compare pain at 2 months after rib osteosynthesis versus medical therapy.

Methods

This trial is a pragmatic multicenter, randomized, superiority, controlled, two-arm, not-blinded, trial that compares pain evolution between rib fixation and standard pain medication versus standard pain medication alone in patients with uncomplicated rib fractures. The study takes place in three hospitals of Thoracic Surgery of Western Switzerland. Primary outcome is pain measured by the brief pain inventory (BPI) questionnaire at 2 months post-surgery. The study includes follow-up assessments at 1, 2, 3, 6, and 12 months after discharge. To be able to detect at least 2 point-difference on the BPI between both groups (standard deviation 2) with 90% power and two-sided 5% type I error, 46 patients per group are required. Adjusting for 10% drop-outs leads to 51 patients per group.

Discussion

Uncomplicated rib fractures have a significant medico-economic impact. Surgical treatment with rib fixation could result in better clinical recovery of patients with uncomplicated rib fractures. These improved outcomes could include less acute and chronic pain, improved pulmonary function and quality of life, and shorter return to work. Finally, surgical treatment could then result in less financial costs.

Trial registration

ClinicalTrials.​govNCT04745520. Registered on 8 February 2021.
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Metadata
Title
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)
Authors
Jean Yaniss Perentes
Michel Christodoulou
Etienne Abdelnour-Berchtold
Wolfram Karenovics
Angèle Gayet-Ageron
Michel Gonzalez
Thorsten Krueger
Frédéric Triponez
Philippe Terrier
Benoît Bédat
Publication date
01-12-2022
Publisher
BioMed Central
Keyword
Rib Fracture
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06509-0

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