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

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Rib Fracture Multiple
• Intervention / Treatment: Procedure: internal fixation of mulitiple rib fracture

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 20030
      • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
conversion to tracheal intubation	index of consciousness(IOC): If the scale low zhan 40 or high than 60, it need intubation	during surgery
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
operation time	operation time	during surgery
blood loss	blood loss	during surgery
days of stay hospital	days of stay hospital	from the date of hospitalization to the date of leave hospital,assessed up to 100 months
costs of stay hospital	costs of stay hospital	from the date of hospitalization to the date of leave hospital,assessed up to 100 months
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
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
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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
• Investigators: Study Chair: Yi Yang, Shanghai Jiao Tong University affiliated 6th people's hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: August 7, 2020
• First Submitted That Met QC Criteria: August 27, 2020
• First Posted (Actual): September 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Multiple Trauma; Rib Fractures; Fractures, Multiple
• Other Study ID Numbers: 2020-036-(1)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No