Paravertebral Block for Proximal Humeral Fracture Surgery

NCT03919422 | Completed Results

• 1 other identifier: 2019-030
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Humeral Fracture

Keywords

thoracic paravertebral block; regional anesthesia; elderly; proximal humeral fracture; brachial plexus block; cervical plexus block; intercostobrachial nerve

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Assessment of Sensory Blockade

  20 minutes after all the nerve block operations have been finished

• Proportion of Participants Completed the Procedure With Remifentanil

  throughout the operation duration, an average of 2 to 3 hours

• Proportion of Participants Conversed Into General Anesthesia(Laryngeal Mask Airway,LMA)

  throughout the operation duration, an average of 2 to 3 hours

• Cumulative Doses of Intraoperative Vasoactive Medications (Urapidil,Atropine, Ephedrine)

  At the end of surgical procedure(an average of 2 to 3 hours)

• Cumulative Doses of Intraoperative Vasoactive Medications (Deoxyepinephrine)

  At the end of surgical procedure(an average of 2 to 3 hours)

Study Arms (2)

IC group

ACTIVE COMPARATOR

Interscalene brachial plexus-Cervical plexus

Procedure: interscalene brachial plexus block and superficial cervical plexus block

ICTP group

EXPERIMENTAL

Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade

Procedure: T2 paravertebral block; Procedure: interscalene brachial plexus block and superficial cervical plexus block

Interventions

T2 paravertebral block PROCEDURE

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).

Also known as: T2 PVB(paravertebral blockade )

ICTP group

interscalene brachial plexus block and superficial cervical plexus block PROCEDURE

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.

Also known as: IC block

IC group; ICTP group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

Related Publications (2)

• 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.

  PMID: 35360431 DERIVED

• 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.

  PMID: 32075674 DERIVED

MeSH Terms

Conditions

Shoulder Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Shoulder Injuries

Results Point of Contact

• Title: Dr. Junfen Zhang, director of the clinical trial
• Organization: Department of Anesthesiology, Shanghai Jiao Tong University Affiliated Sixth People's Hospital

zhangjunfeng@sjtu.edu.cn

+8618930173689

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2019
• First Posted: April 18, 2019
• Study Start: May 5, 2019
• Primary Completion: August 25, 2020
• Study Completion: August 26, 2020
• Last Updated: January 5, 2021
• Results First Posted: January 5, 2021

Record last verified: 2021-01

Locations

CN (1)