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CompletedNCT04536311Updated Apr 27, 2021

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

An interventional study of internal fixation of mulitiple rib fracture in Rib Fracture Multiple and Anesthesia, Local, sponsored by Shanghai Jiao Tong University Affiliated Sixth People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-27.

Sponsored by Shanghai Jiao Tong University Affiliated Sixth People's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Sep 2019, registered Aug 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Rib Fracture Multiple
  • Anesthesia, Local
03

In context

Fractures, Multiple

14 studies on the registry are indexed under Fractures, Multiple; 4 are open to participants now.

Browse Fractures, Multiple studies →

Lead sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital is the lead sponsor of 40 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • I-II
  • \<30
  • Preoperative arterial partial pressure of oxygen > 60mmhg
  • Partial pressure of carbon dioxide \< 50mmhg

Exclusion criteria

Exclusion Criteria:

  • Difficult airway
  • History of esophageal reflux
  • Myasthenia gravis
  • Coagulation disorders
  • Gastrointestinal ulcer
  • Gastrointestinal bleeding
  • Anesthetic drugs allergy history
  • Asthma
  • Pregnant women.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • 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

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

06

What researchers measure

Primary outcomes

  1. conversion to tracheal intubation

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

    Time frame: during surgery

  2. 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

    Time frame: 6 hours after operation

  3. 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

    Time frame: 12 hours after operation

  4. 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

    Time frame: 24 hours after operation

Secondary outcomes

  1. operation time

    operation time

    Time frame: during surgery

  2. blood loss

    blood loss

    Time frame: during surgery

  3. days of stay hospital

    days of stay hospital

    Time frame: from the date of hospitalization to the date of leave hospital,assessed up to 100 months

  4. costs of stay hospital

    costs of stay hospital

    Time frame: from the date of hospitalization to the date of leave hospital,assessed up to 100 months

  5. 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

    Time frame: 6 hours after operation

  6. 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

    Time frame: 12 hours after operation

  7. 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

    Time frame: 24 hours after operation

07

Study locations

1 site
  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital
    Shanghai, Shanghai 20030, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04536311
Lead sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Responsible party
Weigang Zhao (Clinical Professor, Shanghai Jiao Tong University Affiliated Sixth People's Hospital) — Principal investigator
First posted
Sep 2, 2020
Start date
Sep 1, 2019
Primary completion
Sep 30, 2019
Completion
Oct 1, 2020
Last update
Apr 27, 2021

Study contacts

Yi Yang
study chair · Shanghai Jiao Tong University affiliated 6th people's hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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