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

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04536311
Enrollment
20
Registered
2020-09-02
Start date
2019-09-01
Completion date
2020-10-01
Last updated
2021-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Local, Rib Fracture Multiple

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.

Interventions

PROCEDUREinternal 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

Sponsors

Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
conversion to tracheal intubationduring surgeryindex of consciousness(IOC): If the scale low zhan 40 or high than 60, it need intubation
pain score6 hours after operationNumerical 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

MeasureTime frameDescription
days of stay hospitalfrom the date of hospitalization to the date of leave hospital,assessed up to 100 monthsdays of stay hospital
operation timeduring surgeryoperation time
PONV score6 hours after operationVisual 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
costs of stay hospitalfrom the date of hospitalization to the date of leave hospital,assessed up to 100 monthscosts of stay hospital
blood lossduring surgeryblood loss

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026