Surgical Stabilization of Rib Fractures While Awake or Under Appropriate Sedation by Paravertebral Block

Study Overview
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Brief Summary
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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
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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.

Official Title
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Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Conditions
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Rib Fracture Multiple, Anesthesia, Local

Intervention / Treatment
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* Procedure: internal fixation of mulitiple rib fracture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paravertebral block in surgical stabilization of rib fractures under awake or appropriate sedation<br>patients receive internal fixation for multiple rib fractures using paravertebral nerve block anesthesia in awareness status and keep spontaneous breath | Procedure: internal fixation of mulitiple rib fracture<br>* The dislocated rib fracture was anatomically reduced, and then fixed with appropriate equipment to prevent the fracture from being displaced again<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| conversion to tracheal intubation | index of consciousness(IOC): If the scale low zhan 40 or high than 60, it need intubation | during surgery | 
| pain score | 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 | 6 hours after operation | 
| pain score | 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 | 12 hours after operation | 
| pain score | 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 | 24 hours after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operation time | operation time | during surgery | 
| blood loss | blood loss | during surgery | 
| days of stay hospital | days of stay hospital | from the date of hospitalization to the date of leave hospital,assessed up to 100 months | 
| costs of stay hospital | costs of stay hospital | from the date of hospitalization to the date of leave hospital,assessed up to 100 months | 
| PONV score | Visual analogue scale (VAS). 1-10 is used to represent different degrees of nausea and vomiting. 1   4 was mild, 5   6 was moderate, 7   10 was severe | 6 hours after operation | 
| PONV score | Visual analogue scale (VAS). 1-10 is used to represent different degrees of nausea and vomiting. 1   4 was mild, 5   6 was moderate, 7   10 was severe | 12 hours after operation | 
| PONV score | Visual analogue scale (VAS). 1-10 is used to represent different degrees of nausea and vomiting. 1   4 was mild, 5   6 was moderate, 7   10 was severe | 24 hours after operation |