Comparing the Efficacy of Conservative Treatment With Minimally Invasive Surgery in the Treatment of Rib Fractures

Not Applicable

• Conditions: Rib Fractures; Chest Trauma; Surgery--Complications
• Interventions: Procedure: Conservative treatment; Procedure: surgical treatment

• Registration Number: NCT04541758
• Lead Sponsor: Shanghai 6th People's Hospital

Brief Summary

Open, randomized, parallel controlled prospective clinical study design was used in this study.Subjects were patients with 2-4 displaced non-flail rib fractures.Operation group (Group 1) : minimally invasive internal fixation operation group under spontaneous breathing anesthesia.In the operation group of minimally invasive internal fixation under autonomic respiratory anesthesia, the fracture was determined preoperatively by chest CT+ three-dimensional reconstruction of the ribs, and the optimal incision location was determined. The fracture was exposed through as many small incisions as possible, and fixed with titanium plate or clon-type plate. During the operation, the autonomic respiratory anesthesia and paraviral nerve block technology was adopted.In the conservative group (group 2), routine treatment measures such as analgesia and chest strap fixed were adopted.The purpose of this study was to evaluate the safety, feasibility, and efficacy of minimally invasive and conservative treatment for rib fractures with different Numbers of displaced ends.

Detailed Description

An open, randomized, parallel controlled prospective clinical study design type was used in this study. Subjects were patients with two to four displaced non-flail chest fractures of the ribs. Operation group (Group 1) : minimally invasive internal fixation operation group under spontaneous breathing anesthesia. In the operation group of minimally invasive internal fixation under autonomic respiratory anesthesia, the fracture was determined preoperatively by chest CT+ three-dimensional reconstruction of the ribs, and the optimal incision location was determined. The fracture was exposed through as many small incisions as possible, and fixed with titanium plate or clon-type plate. During the operation, the autonomic respiratory anesthesia and paraviral nerve block technology was adopted. In the conservative group (group 2), routine treatment measures such as analgesia, hemostasis and chest band fixation were adopted. The effects of the two treatments on lung function, pain index, complications and QoL were evaluated. It provides theoretical basis for the treatment of rib fracture

Study Timeline

• Study First Submitted: 2020-08-15
• Study First Submitted QC: 2020-09-07
• Study First Posted: 2020-09-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-17
• Last Update Posted: 2021-01-20
• Study Start: 2021-03-01
• Primary Completion: 2023-06-10
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

1. Unilateral thoracic trauma, fractured ends of rib fractures displaced 2-4 places
2. Displaced fracture（CT image shows double displacement of bone cortex） located in the 3rd to 10th rib
3. The number of broken ends of displaced fractures is greater than that of undisplaced fractures
4. The length of time from injury to hospitalization <24 hours
5. Age range（18-70）
6. ASA grade I-II
7. BMI < 30
8. Preoperative partial arterial oxygen pressure >60mmHg, partial arterial carbon dioxide pressure <50mmHg

Exclusion Criteria

1. Difficult airway
2. History of esophageal reflux
3. Myasthenia gravis
4. Abnormal coagulation system
5. History of gastrointestinal ulcer or bleeding
6. History of anaesthesia related drug allergy

A history of asthma or chronic obstructive emphysema

8. Women during pregnancy

9. Flail chest

10. Combined with severe craniocerebral trauma and external abdominal injuries

11. Recent use of clopidogrel, warfarin and aspirin seriously affects blood clotting

12. Self-administered analgesics after injury

13.Massive hemopneumothorax requires emergency surgery

14. Patients who cannot tolerate surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative treatment	Conservative treatment	analgesic treatment and chest strap fixation
surgical treatment	surgical treatment	Minimally invasive internal fixation under spontaneous respiratory anesthesia and analgesic treatment and chest strap fixation
surgical treatment	Conservative treatment	Minimally invasive internal fixation under spontaneous respiratory anesthesia and analgesic treatment and chest strap fixation

Primary Outcome Measures

Name	Time	Method
Percentage improvement of lung function FEV1(Forced expiratory volume in one second)	FEV1%(One week after treatment)-FEV1%(Admitted)	FEV1(Forced expiratory volume in one second)，FEV1% ：percentage of the expected value

Secondary Outcome Measures

Name	Time	Method
Percentage improvement of lung function FVC	FVC%(One week after treatment)-FVC%(Admitted)	FVC（forced vital capacity），FVC%：percentage of the expected value
Pain index	Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year	visual analogue scale，VAS（0-10）0：no pain；10：severe pain
Cost of treatment	One year	Sum of all treatment costs
Pleural effusion	Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year	Measured by chest CT
Mortality rate	Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year	Deaths associated with this study
Chronic pain	Three month after treatment;Half a year;One year	Pain lasting more than three months（It is suggested in the related article that pain lasting more than 3 months is chronic pain）visual analogue scale，VAS（0-10）0：no pain；10：severe pain
Duration of analgesic medication	intraoperative；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year	Duration of analgesic medication
Percentage improvement of lung function PEF	PEF%(One week after treatment)-PEF%(Admitted)	PEF（peak expiratory flow ），PEF%：percentage of the expected value
Length of hospital stay	Admitted；One week after treatment；One month after treatment;Three month after treatment;Half a year;One year	Length of hospital stay
Quality of Life score	One week after treatment；One month after treatment;Three month after treatment;Half a year;One year	The Barthel index of ADL
Time to resume routine work	One week after treatment；One month after treatment;Three month after treatment;Half a year;One year	Time to resume routine work