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Completed

NCT Number: NCT04536311

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

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.

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Key information

Conditions

Rib Fracture Multiple Anesthesia, Local

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, 20030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

internal fixation of mulitiple rib fracture

Procedure

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. operation time

    Time frame: during surgery

    operation time

  2. blood loss

    Time frame: during surgery

    blood loss

  3. days of stay hospital

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

    days of stay hospital

  4. costs 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

  5. PONV score

    Time frame: 6 hours after operation

    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

  6. PONV score

    Time frame: 12 hours after operation

    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

  7. PONV score

    Time frame: 24 hours after operation

    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

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Other

Registry information

Official study title

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Sep 2, 2020
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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