Surgical Stabilization of Rib Fractures While Awake or Under Appropriate Sedation by Paravertebra… (NCT04536311) | Clinical Trial Compass
CompletedNot Applicable
Surgical Stabilization of Rib Fractures While Awake or Under Appropriate Sedation by Paravertebral Block
China20 participantsStarted 2019-09-01
Plain-language summary
Tracheal intubation and general anesthesia has been considered a safe and conventional routine methodology for thoracic surgery, include multiple rib fratcure. However,adverse effects such as sore throat, pain, hoarseness, and respiratory complications are common after that. In this study, we decide to perform surgical stabiliazation of rib fractures by paravertebral block surgical stabiliazation of rib fractures under awake or appropriate sedation without endotracheal intubation keeping spontaneous respiration to investigate its safety and feasibility.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Simple rib fracutures patients
* No other truama
* Unilatieral rib fractures
* Total number of rib fractures is less than 5
* At least one rib dislocation
* 18-80 years old
* ASA grade I-II
* BMI\<30
* Preoperative arterial partial pressure of oxygen \> 60mmhg
* Partial pressure of carbon dioxide \< 50mmhg
Exclusion Criteria:
* Difficult airway
* History of esophageal reflux
* Myasthenia gravis
* Coagulation disorders
* Gastrointestinal ulcer
* Gastrointestinal bleeding
* Anesthetic drugs allergy history
* Asthma
* Chronic obstructive pulmonary disease
* Pregnant women.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
conversion to tracheal intubation
Timeframe: during surgery
2
pain score
Timeframe: 6 hours after operation
3
pain score
Timeframe: 12 hours after operation
4
pain score
Timeframe: 24 hours after operation
Trial details
NCT IDNCT04536311
SponsorShanghai Jiao Tong University Affiliated Sixth People's Hospital