Paravertebral Block for Proximal Humeral Fracture Surgery

Study Overview
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Brief Summary
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This study evaluates the effects of T2 paravertebral block block improving interscalene brachial plexus block and superficial cervical plexus block on the relief of pain intensity during elderly proximal humerus fracture fixation surgery. The brachial plexus and cervical plexus block(IC block) will be performed in half of participants, while the T2 paravertebral block combined with IC block will be performed in the other half.

Official Title
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Effectiveness of Additional Thoracic Paravertebral Block in Improving Anesthetic Effects of Regional Anesthesia for Proximal Humeral Fracture Surgery in Elderly Patients: Study Protocol for a Randomized Controlled Trial

Conditions
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Proximal Humeral Fracture

Intervention / Treatment
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* Procedure: T2 paravertebral block
* Procedure: interscalene brachial plexus block and superficial cervical plexus block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant age≥ 65 years Body mass index (BMI) < 30kg/m2 American Society of Anesthesiologists (ASA) classification I-II Anterior operative incision approach Exclusion Criteria: Request for general anesthesia Nerve block is unable to be performed due to various reasons Coagulation dysfunction or anticoagulation therapy History of upper limb nerve injury or phrenic nerve injury Multiple trauma Uncontrolled respiratory disease (severe chronic obstructive pulmonary disease, asthma, pulmonary infection, pneumothorax, etc.) Uncontrolled hypertension (systolic pressure over 180mmHg or diastolic pressure over 110mmHg) Uncontrolled heart disease (coronary heart disease, valvular disease or arrhythmia, etc.) Stroke or cognitive dysfunction (unable to communicate or cooperate) Hypersensitivity or allergy to anesthetics (ropivacaine or remifentanil)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IC group<br>Interscalene brachial plexus-Cervical plexus | Procedure: interscalene brachial plexus block and superficial cervical plexus block<br>* 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.<br>* Other names: IC block;|
| Experimental: ICTP group<br>Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade | Procedure: T2 paravertebral block<br>* 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).<br>* Other names: T2 PVB(paravertebral blockade );Procedure: interscalene brachial plexus block and superficial cervical plexus block<br>* 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.<br>* Other names: IC block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate(Ability to Proceed With Surgery Without the Need for Intravenous Narcotics, General Anaesthesia, Rescue Blocks or Local Infiltration by the Surgeon) | Success rate - was equivalent to surgical anesthesia, defined as the ability to proceed with surgery without the need for intravenous narcotics, general anaesthesia, rescue blocks or local infiltration by the surgeon. | throughout the operation duration, an average of 2 to 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Sensory Blockade | Sensory blockade graded from 0 to 2(0= normal sensation, 1= decreased sensation and 2= no perception) by applying pinprick and cold test to the different parts of shoulder | 20 minutes after all the nerve block operations have been finished | 
| Proportion of Participants Completed the Procedure With Remifentanil | When the primary outcome of the participant is assessed by failure during the surgery, 0.25μg/kg/min remifentanil will be given via intravenous infusion. Two minutes later, the procedure will continue if the participant can tolerate the pain. | throughout the operation duration, an average of 2 to 3 hours | 
| Proportion of Participants Conversed Into General Anesthesia(Laryngeal Mask Airway,LMA) | When the primary outcome of the participant is assessed by failure during the surgery, 0.25μg/kg/min remifentanil will be given via intravenous infusion. Two minutes later, if the participant cannot tolerate the pain, a general anesthesia with LMA will be given. | throughout the operation duration, an average of 2 to 3 hours | 
| Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine) | Cumulative doses of vasoactive drugs required such as urapidil,atropine, ephedrine during the surgery. | At the end of surgical procedure(an average of 2 to 3 hours) | 
| Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine) | Cumulative doses of intravenous deoxyepinephrine required during the surgery. | At the end of surgical procedure(an average of 2 to 3 hours) | 
| Complications Related With Anesthesia | Presence or absence of local anesthetic systemic toxicity, pneumothorax, and epidural block, total spinal block, hematoma | within 24 hours since the nerve block finished | 
| Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea) | Number of participants with hypertension, hypotension, bradycardia, tachycardia or dyspnea during the surgery. | throughout the operation duration, an average of 2 to 3 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thoracic paravertebral block, regional anesthesia, elderly, proximal humeral fracture, brachial plexus block, cervical plexus block, intercostobrachial nerve