Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04745520
Status:
UNKNOWN
Last Update Posted:
2022-05-18
First Post:
2020-12-06
Brief Title:
Randomized Clinical Trial of Rib Fixation Versus Medical Analgesia in Uncomplicated Rib Fractures on Pain Control
Sponsor:
Benoît Bédat
Organization:
University Hospital Geneva
Study Overview
Official Title:
Comparison of Rib Fixation With Medical Analgesia in Patients With Uncomplicated Rib Fractures on Pain Control a Multi-center Randomized Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAROS
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
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
Detailed Description:
Background Until recently functional disability and chronic pain and following uncomplicated rib fractures have been scarcely studied Studies described persistent pain and disability in respectively 59 and 76 of patients at two months and in 22 and 53 of patients at 6 months In a retrospective study including 216 patients with an isolated thoracic injury only 342 of patients had a good recovery at one year and the six-month return to work rate is of 63 Persistent pain and disability following rib fractures therefore result in a large psycho-socio-economic impact for health-care system The only predictive factor for persistent pain and disability is the pain intensity within the first few days after injury Similarly the intensity of pain within the first days after thoracotomy predicts long-term post-thoracotomy pain In a recent meta-analysis epidural analgesia provides better acute pain relief than intravenous paravertebral and intercostal interventions While meta-analyses conclude that operative fixation of complicated flail chest provide better outcome the impact of surgery on pain in uncomplicated rib fracture is seldom studied Some retrospective studies showed promising results of rib fixation with surgery in patients with uncomplicated rib fractures A study showed that rib fixation reduced postoperative analgesic requirements Similarly another study showed that pain was significantly reduced one month after surgery as compared to a non-surgical approach Finally it has been recently observed a decreased mortality and respiratory complications after surgery in patients over 65 years old as well as a better functional status at two weeks two months and four months
Trial objectives No previous studies have provided definitive evidence for recommending rib fixation over simple pain medication to control pain Our hypothesis is that a surgical approach may have further benefits as compared to a conservative treatment The primary objective of the study is to compare pain two months after injury between two groups group 1 patients who are treated with surgery and analgesic treatment and group 2 patients who are treated with analgesic treatment alone The secondary objective is to perform a longitudinal analysis over one year of the following parameters amount of pain medication quality of life anxiety and depression pulmonary capacity return to work and adverse events Financial aspects are also investigated
Trial objectives No previous studies have provided definitive evidence for recommending rib fixation over simple pain medication to control pain Our hypothesis is that a surgical approach may have further benefits as compared to a conservative treatment The primary objective of the study is to compare pain two months after injury between two groups group 1 patients who are treated with surgery and analgesic treatment and group 2 patients who are treated with analgesic treatment alone The secondary objective is to perform a longitudinal analysis over one year of the following parameters amount of pain medication quality of life anxiety and depression pulmonary capacity return to work and adverse events Financial aspects are also investigated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None