Clinical trial NCT04536311: Surgical Stabilization of Rib Fractures While Awake or Under Appropriate Sedation by Paravertebral Block
Official title: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rib Fracture Multiple
Anesthesia, Local
Lead sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: conversion to tracheal intubation
timeFrame: during surgery
measure: pain score
timeFrame: 6 hours after operation
measure: pain score
timeFrame: 12 hours after operation
measure: pain score
timeFrame: 24 hours after operation
Secondary outcomes:
measure: operation time
timeFrame: during surgery
measure: blood loss
timeFrame: during surgery
measure: days of stay hospital
timeFrame: from the date of hospitalization to the date of leave hospital,assessed up to 100 months
measure: costs of stay hospital
timeFrame: from the date of hospitalization to the date of leave hospital,assessed up to 100 months
measure: PONV score
timeFrame: 6 hours after operation
measure: PONV score
timeFrame: 12 hours after operation
measure: PONV score
timeFrame: 24 hours after operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Jiao Tong University affiliated 6th people's hospital
name: Yi Yang
role: STUDY_CHAIR
References: