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

Primary Purpose

Rib Fracture Multiple, Anesthesia, Local

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
internal fixation of mulitiple rib fracture
Sponsored by
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rib Fracture Multiple

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paravertebral block in surgical stabilization of rib fractures under awake or appropriate sedation

Arm Description

patients receive internal fixation for multiple rib fractures using paravertebral nerve block anesthesia in awareness status and keep spontaneous breath

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

operation time
operation time
blood loss
blood loss
days of stay hospital
days of stay hospital
costs of stay hospital
costs of stay hospital
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
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
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

Full Information

First Posted
August 7, 2020
Last Updated
April 23, 2021
Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04536311
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fracture Multiple, Anesthesia, Local

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paravertebral block in surgical stabilization of rib fractures under awake or appropriate sedation
Arm Type
Experimental
Arm Description
patients receive internal fixation for multiple rib fractures using paravertebral nerve block anesthesia in awareness status and keep spontaneous breath
Intervention Type
Procedure
Intervention Name(s)
internal fixation of mulitiple rib fracture
Intervention Description
The dislocated rib fracture was anatomically reduced, and then fixed with appropriate equipment to prevent the fracture from being displaced again
Primary Outcome Measure Information:
Title
conversion to tracheal intubation
Description
index of consciousness(IOC): If the scale low zhan 40 or high than 60, it need intubation
Time Frame
during surgery
Title
pain score
Description
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
Time Frame
6 hours after operation
Title
pain score
Description
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
Time Frame
12 hours after operation
Title
pain score
Description
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
Time Frame
24 hours after operation
Secondary Outcome Measure Information:
Title
operation time
Description
operation time
Time Frame
during surgery
Title
blood loss
Description
blood loss
Time Frame
during surgery
Title
days of stay hospital
Description
days of stay hospital
Time Frame
from the date of hospitalization to the date of leave hospital,assessed up to 100 months
Title
costs of stay hospital
Description
costs of stay hospital
Time Frame
from the date of hospitalization to the date of leave hospital,assessed up to 100 months
Title
PONV score
Description
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
Time Frame
6 hours after operation
Title
PONV score
Description
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
Time Frame
12 hours after operation
Title
PONV score
Description
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
Time Frame
24 hours after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Yang
Organizational Affiliation
Shanghai Jiao Tong University affiliated 6th people's hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
20030
Country
China

12. IPD Sharing Statement

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

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