Paravertebral Block for Proximal Humeral Fracture Surgery

Proximal Humeral Fracture Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03919422
• Other study ID #: 2019-030
• Status: Completed
• Phase: N/A
• Start date: May 5, 2019
• Est. completion date: August 26, 2020

Study information

• Verified date: January 2021
• Source: Shanghai 6th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 26, 2020
• Est. primary completion date: August 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humeral Fracture
• Shoulder Fractures

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Shanghai Jiao Tong University Affiliated Sixth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 6th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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