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

Anesthesia, Local Clinical Trial

Official title:

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536311
• Other study ID #: 2020-036-(1)
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: April 2021
• Source: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 1, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local
• Fractures, Bone
• Rib Fracture Multiple
• Rib Fractures

Intervention

Procedure:
• internal fixation of mulitiple rib fracture
The dislocated rib fracture was anatomically reduced, and then fixed with appropriate equipment to prevent the fracture from being displaced again

Locations

Country	Name	City	State
China	Shanghai Jiao Tong University Affiliated Sixth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	conversion to tracheal intubation	index of consciousness(IOC): If the scale low zhan 40 or high than 60, it need intubation	during surgery
Primary	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
Primary	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
Primary	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	operation time	operation time	during surgery
Secondary	blood loss	blood loss	during surgery
Secondary	days of stay hospital	days of stay hospital	from the date of hospitalization to the date of leave hospital,assessed up to 100 months
Secondary	costs of stay hospital	costs of stay hospital	from the date of hospitalization to the date of leave hospital,assessed up to 100 months
Secondary	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
Secondary	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
Secondary	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