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Paravertebral Block for Proximal Humeral Fracture Surgery

Shanghai Jiao Tong University logo

Shanghai Jiao Tong University

Status

Completed

Conditions

Proximal Humeral Fracture

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03919422
2019-030

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

IC group
Active Comparator group
Description:
Interscalene brachial plexus-Cervical plexus
Treatment:
Procedure: interscalene brachial plexus block and superficial cervical plexus block
ICTP group
Experimental group
Description:
Interscalene brachial plexus-Cervical plexus combined with T2 Paravertebral blockade
Treatment:
Procedure: interscalene brachial plexus block and superficial cervical plexus block
Procedure: T2 paravertebral block

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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