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

Not Applicable
Completed
Conditions
Anesthesia, Local
Rib Fracture Multiple
Interventions
Procedure: internal fixation of mulitiple rib fracture
Registration Number
NCT04536311
Lead Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Paravertebral block in surgical stabilization of rib fractures under awake or appropriate sedationinternal fixation of mulitiple rib fracturepatients receive internal fixation for multiple rib fractures using paravertebral nerve block anesthesia in awareness status and keep spontaneous breath
Primary Outcome Measures
NameTimeMethod
conversion to tracheal intubationduring surgery

index of consciousness(IOC): If the scale low zhan 40 or high than 60, it need intubation

pain score24 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 Outcome Measures
NameTimeMethod
operation timeduring surgery

operation time

blood lossduring surgery

blood loss

days of stay hospitalfrom the date of hospitalization to the date of leave hospital,assessed up to 100 months

days of stay hospital

costs of stay hospitalfrom the date of hospitalization to the date of leave hospital,assessed up to 100 months

costs of stay hospital

PONV score24 hours after operation

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

Trial Locations

Locations (1)

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

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Shanghai, Shanghai, China

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