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

NCT ID: NCT04536311

Last Updated: 2021-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Rib Fracture Multiple Anesthesia, Local

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

internal fixation of mulitiple rib fracture

Intervention Type PROCEDURE

The dislocated rib fracture was anatomically reduced, and then fixed with appropriate equipment to prevent the fracture from being displaced again

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Weigang Zhao

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yi Yang

Role: STUDY_CHAIR

Shanghai Jiao Tong University affiliated 6th people's hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 40119455 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-036-(1)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.