Paravertebral Block for Proximal Humeral Fracture Surgery
NCT ID: NCT03919422
Last Updated: 2021-01-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2019-05-05
2020-08-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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IC group
Interscalene brachial plexus-Cervical plexus
interscalene brachial plexus block and superficial cervical plexus block
An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
ICTP group
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
T2 paravertebral block
Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).
interscalene brachial plexus block and superficial cervical plexus block
An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
Interventions
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T2 paravertebral block
Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).
interscalene brachial plexus block and superficial cervical plexus block
An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Body mass index (BMI) \< 30kg/m2
3. American Society of Anesthesiologists (ASA) classification I-II
4. Anterior operative incision approach
Exclusion Criteria
2. Nerve block is unable to be performed due to various reasons
3. Coagulation dysfunction or anticoagulation therapy
4. History of upper limb nerve injury or phrenic nerve injury
5. Multiple trauma
6. Uncontrolled respiratory disease (severe chronic obstructive pulmonary disease, asthma, pulmonary infection, pneumothorax, etc.)
7. Uncontrolled hypertension (systolic pressure over 180mmHg or diastolic pressure over 110mmHg)
8. Uncontrolled heart disease (coronary heart disease, valvular disease or arrhythmia, etc.)
9. Stroke or cognitive dysfunction (unable to communicate or cooperate)
10. Hypersensitivity or allergy to anesthetics (ropivacaine or remifentanil)
65 Years
ALL
No
Sponsors
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Shanghai 6th People's Hospital
OTHER
Responsible Party
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Xiaofeng WANG
Principal Investigator
Locations
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Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Countries
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References
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Wang X, Zhang H, Chen Y, Zhang Q, Xie Z, Liao J, Jiang W, Zhang J. Is It Useful and Necessary to Add a T2 Paravertebral Block to the Regional Anesthesia During Proximal Humeral Fracture Surgery in Elderly Patients? A Prospective and Randomized Controlled Trial. Front Surg. 2022 Mar 14;9:755298. doi: 10.3389/fsurg.2022.755298. eCollection 2022.
Wang X, Zhang H, Xie Z, Zhang Q, Jiang W, Zhang J. The effectiveness of additional thoracic paravertebral block in improving the anesthetic effects of regional anesthesia for proximal humeral fracture surgery in elderly patients: study protocol for a randomized controlled trial. Trials. 2020 Feb 19;21(1):204. doi: 10.1186/s13063-020-4078-9.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2019-030
Identifier Type: -
Identifier Source: org_study_id
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