Rib Fracture MultipleNCT04536311
Surgical Stabilization of Rib Fractures While Awake or Under Appropriate Sedation by Paravertebral Block
A study testing internal fixation of mulitiple rib fracture in people with Rib Fracture Multiple and Anesthesia, Local, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rib Fracture Multiple, Anesthesia, Local
- What is being tested?
- internal fixation of mulitiple rib fracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- ASA grade I-II
- BMI<30
- Preoperative arterial partial pressure of oxygen > 60mmhg
- Partial pressure of carbon dioxide < 50mmhg
Who cannot join
- Difficult airway
- History of esophageal reflux
- Myasthenia gravis
- Coagulation disorders
- Gastrointestinal ulcer
- Gastrointestinal bleeding
Show all 10Show fewer
- Anesthetic drugs allergy history
- Asthma
- Chronic obstructive pulmonary disease
- Pregnant women.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality, 20030
About this study
Official title: 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.
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.
- Conditions
- Rib Fracture Multiple, Anesthesia, Local
- Being tested
- internal fixation of mulitiple rib fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internal fixation of mulitiple rib fractureProcedure or surgery
The dislocated rib fracture was anatomically reduced, and then fixed with appropriate equipment to prevent the fracture from being displaced again
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral block in surgical stabilization of rib fractures under awake or appropriate sedation | Experimental | patients receive internal fixation for multiple rib fractures using paravertebral nerve block anesthesia in awareness status and keep spontaneous breath Receives: Procedure: internal fixation of mulitiple rib fracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
conversion to tracheal intubation
index of consciousness(IOC): If the scale low zhan 40 or high than 60, it need intubation
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours after operation
Secondary outcomes (7)
operation time
operation time
Measured: during surgery
blood loss
blood loss
Measured: during surgery
days of stay hospital
days of stay hospital
Measured: from the date of hospitalization to the date of leave hospital,assessed up to 100 months
costs of stay hospital
costs of stay hospital
Measured: 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
Measured: 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
Measured: 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
Measured: 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Sep 2019
- Primary completion30 Sep 2019
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rib Fracture MultipleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weigang Zhao, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Investigators
- Yi Yang, Study chair, Shanghai Jiao Tong University affiliated 6th people's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536311
- Sponsor's protocol ID
- 2020-036-(1)
- Status last verified
- Apr 2021
- First submitted
- 7 Aug 2020
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu W, Gao X, Liu P, Zhao W, Yang Y. Paravertebral block analgesia during surgical stabilization for rib fractures patients under conscious state: a single-arm, pilot study and post-hoc analysis. J Cardiothorac Surg. 2025 Mar 21;20(1):161. doi: 10.1186/s13019-025-03397-8.
PubMed 40119455
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- ClinicalTrials.gov ID
- NCT04536311
- Acronym / sponsor ID
- 2020-036-(1)
- Conditions
- Rib Fracture Multiple, Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paravertebral block in surgical stabilization of rib fractures under awake or appropriate sedation | Experimental | Procedure: internal fixation of mulitiple rib fracturepatients receive internal fixation for multiple rib fractures using paravertebral nerve block anesthesia in awareness status and keep spontaneous breath |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Simple rib fracutures patients
- No other truama
- Unilatieral rib fractures
- Total number of rib fractures is less than 5
- At least one rib dislocation
Key exclusion criteria (10 listed)
- Difficult airway
- History of esophageal reflux
- Myasthenia gravis
- Coagulation disorders
- Gastrointestinal ulcer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| internal fixation of mulitiple rib fractureThe dislocated rib fracture was anatomically reduced, and then fixed with appropriate equipment to prevent the fracture from being displaced again | Procedure or surgery | Paravertebral block in surgical stabilization of rib fractures under awake or appropriate sedation |
Primary outcome
conversion to tracheal intubation
Time frame: during surgery
index of consciousness(IOC): If the scale low zhan 40 or high than 60, it need intubation
pain score
Time frame: 6 hours after operation
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
Time frame: 12 hours after operation
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
Time frame: 24 hours after operation
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
7 secondary outcomes
operation time
Time frame: during surgery
blood loss
Time frame: during surgery
days of stay hospital
Time frame: from the date of hospitalization to the date of leave hospital,assessed up to 100 months
costs of stay hospital
Time frame: from the date of hospitalization to the date of leave hospital,assessed up to 100 months
PONV score
Time frame: 6 hours after operation
PONV score
Time frame: 12 hours after operation
PONV score
Time frame: 24 hours after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Derived from this study: PubMed 40119455Wu W, Gao X, Liu P, Zhao W, Yang Y. Paravertebral block analgesia during surgical stabilization for rib fractures patients under conscious state: a single-arm, pilot study and post-hoc analysis. J Cardiothorac Surg. 2025 Mar 21;20(1):161. doi: 10.1186/s13019-025-03397-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Yang study chair
Shanghai Jiao Tong University affiliated 6th people's hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internal fixation of mulitiple rib fracture in people with Rib Fracture Multiple and Anesthesia, Local, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
conversion to tracheal intubation (time frame: during surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04536311, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.