Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- conversion to tracheal intubation
Overview
Brief 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.
Detailed Description
Rib fracture is common in the world,especially in chest trauma. Conservative treatment is used to it for many years but the effect is not well because of continuous pain caused by the dislocation of broken rib. Surgical stabiliazation of rib fractures can relieve the pain rapidly and help patient recover to work early. This kind of surgery is constantly conducted with tracheal intubation and general anesthesia. However,adverse effects such as sore throat, pain, hoarseness, and respiratory complications are common after that. So we think perform surgical stabiliazation of rib fractures under awake or appropriate sedation without endotracheal intubation keeping spontaneous respiration to investigate its safety and feasibility.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
- •Chronic obstructive pulmonary disease
- •Pregnant women.
Outcomes
Primary Outcomes
conversion to tracheal intubation
Time Frame: during surgery
index of consciousness(IOC): If the scale low zhan 40 or high than 60, it need intubation
pain score
Time Frame: 24 hours after operation
Numerical Rating Scale(NRS): 0-10 is used to represent different degrees of pain, 0 is painless and 10 is severe pain. The grading criteria of pain were: 0: no pain; 1-3: mild pain; 4-6: moderate pain; 7-10: severe pain
Secondary Outcomes
- operation time(during surgery)
- blood loss(during surgery)
- days of stay hospital(from the date of hospitalization to the date of leave hospital,assessed up to 100 months)
- costs of stay hospital(from the date of hospitalization to the date of leave hospital,assessed up to 100 months)
- PONV score(24 hours after operation)
Investigators
Weigang Zhao
Clinical Professor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital