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

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.

Timeline

Start

2021-03-12

Primary completion

2023-11-16

Completion

2024-09-16

Outcome

Outcome not reported

Stopped (Enrollment): “Participant recruitment was too low. One of the reasons is the overly strict exclusion criteria.”

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Drugs

Indications

No indication recorded.