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

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ClinicalTrials.gov Identifier: NCT04536311
Recruitment Status : Completed
First Posted : September 2, 2020
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Weigang Zhao, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rib Fracture Multiple Anesthesia, Local Procedure: internal fixation of mulitiple rib fracture Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Actual Study Start Date : September 1, 2019
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : October 1, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Paravertebral block in surgical stabilization of rib fractures under awake or appropriate sedation
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
The dislocated rib fracture was anatomically reduced, and then fixed with appropriate equipment to prevent the fracture from being displaced again


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. pain score [ Time Frame: 6 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

  3. pain score [ Time Frame: 12 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

  4. 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 Outcome Measures :
  1. operation time [ Time Frame: during surgery ]
    operation time

  2. blood loss [ Time Frame: during surgery ]
    blood loss

  3. days of stay hospital [ Time Frame: from the date of hospitalization to the date of leave hospital,assessed up to 100 months ]
    days of stay hospital

  4. costs of stay hospital [ Time Frame: from the date of hospitalization to the date of leave hospital,assessed up to 100 months ]
    costs of stay hospital

  5. PONV score [ Time Frame: 6 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

  6. PONV score [ Time Frame: 12 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

  7. PONV score [ Time Frame: 24 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04536311


Locations
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China, Shanghai
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai, China, 20030
Sponsors and Collaborators
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Investigators
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Study Chair: Yi Yang Shanghai Jiao Tong University affiliated 6th people's hospital
More Information
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Responsible Party: Weigang Zhao, Clinical Professor, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
ClinicalTrials.gov Identifier: NCT04536311    
Other Study ID Numbers: 2020-036-(1)
First Posted: September 2, 2020    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fractures, Bone
Rib Fractures
Fractures, Multiple
 Wounds and Injuries
Thoracic Injuries
Multiple Trauma