Clinical trial NCT03919422: Paravertebral Block for Proximal Humeral Fracture Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proximal Humeral Fracture
Keywords: thoracic paravertebral block
regional anesthesia
elderly
proximal humeral fracture
brachial plexus block
cervical plexus block
intercostobrachial nerve
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2019-04-18
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Participant age≥ 65 years
2. Body mass index (BMI) \< 30kg/m2
3. American Society of Anesthesiologists (ASA) classification I-II
4. Anterior operative incision approach

Exclusion Criteria:

1. Request for general anesthesia
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)

Primary outcomes:
measure: Success Rate(Ability to Proceed With Surgery Without the Need for Intravenous Narcotics, General Anaesthesia, Rescue Blocks or Local Infiltration by the Surgeon)
timeFrame: throughout the operation duration, an average of 2 to 3 hours
Secondary outcomes:
measure: Assessment of Sensory Blockade
timeFrame: 20 minutes after all the nerve block operations have been finished
measure: Proportion of Participants Completed the Procedure With Remifentanil
timeFrame: throughout the operation duration, an average of 2 to 3 hours
measure: Proportion of Participants Conversed Into General Anesthesia(Laryngeal Mask Airway,LMA)
timeFrame: throughout the operation duration, an average of 2 to 3 hours
measure: Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine)
timeFrame: At the end of surgical procedure(an average of 2 to 3 hours)
measure: Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine)
timeFrame: At the end of surgical procedure(an average of 2 to 3 hours)
measure: Complications Related With Anesthesia
timeFrame: within 24 hours since the nerve block finished
measure: Intraoperative Adverse Reactions (Including Hypertension, Hypotension, Bradycardia, Tachycardia or Dyspnea)
timeFrame: throughout the operation duration, an average of 2 to 3 hours
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiao Tong University Affiliated Sixth People's Hospital
state: Shanghai
Study officials:
References:
citation: 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.
citation: 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.