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

Sponsor
Shanghai Jiao Tong University Affiliated Sixth People's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04536311
Collaborator
(none)
20
1
1
13
1.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: internal fixation of mulitiple rib fracture
N/A

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

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Actual Study Start Date :
Sep 1, 2019
Actual Primary Completion Date :
Sep 30, 2019
Actual Study Completion Date :
Oct 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. conversion to tracheal intubation [during surgery]

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

  2. pain score [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 [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 [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 Outcome Measures

  1. operation time [during surgery]

    operation time

  2. blood loss [during surgery]

    blood loss

  3. days of stay hospital [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 [from the date of hospitalization to the date of leave hospital,assessed up to 100 months]

    costs of stay hospital

  5. PONV score [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Jiao Tong University Affiliated Sixth People's Hospital Shanghai Shanghai China 20030

Sponsors and Collaborators

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Investigators

  • Study Chair: Yi Yang, Shanghai Jiao Tong University affiliated 6th people's hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weigang Zhao, Clinical Professor, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
ClinicalTrials.gov Identifier:
NCT04536311
Other Study ID Numbers:
  • 2020-036-(1)
First Posted:
Sep 2, 2020
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2021