Paravertebral Block for Proximal Humeral Fracture Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Proximal Humeral Fracture
• Intervention / Treatment: Procedure: interscalene brachial plexus block and superficial cervical plexus block; Procedure: T2 paravertebral block

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200233
      • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IC group; Interscalene brachial plexus-Cervical plexus	Procedure: 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 Names: IC block
Experimental: ICTP group; Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade	Procedure: 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 Names: IC block; 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).; Other Names: T2 PVB(paravertebral blockade )

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai 6th People's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2019
• Primary Completion (Actual): August 25, 2020
• Study Completion (Actual): August 26, 2020

Study Registration Dates

• First Submitted: April 14, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 2, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: elderly; regional anesthesia; brachial plexus block; thoracic paravertebral block; cervical plexus block; proximal humeral fracture; intercostobrachial nerve
• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: 2019-030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No