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Completed

NCT Number: NCT04626869

Anterior Suprascapular Nerve Block is an Effective and Diaphragm Protective Approach for Arthroscopic Shoulder Surgery

Interscalene block is still the gold standard in shoulder surgery analgesia. The most important side effect is diaphragm paralysis due to the phrenic nerve being affected. It may cause symptomatic dyspnea, especially in patients with limited respiratory capacity. There are studies showing that an effective analgesia, as much as the interscalene block can do, can be provided by blocking the suprascapular nerve in the neck region.

The aim of our study is to show that the anterior suprascapular block applied with ultra-low volume (5ml) in shoulder arthroscopy operations is at least as effective as the interscalene block and does not cause diaphragm paralysis.

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Key information

Conditions

Diaphragm Paralysis Due to Local Anesthesia Agnosia Analgesia, Arthroscopic Shoulder Surgery Anterior Suprascapular Nerve Block Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Perceptual Disorders Respiration Disorders Respiratory Insufficiency Respiratory Paralysis Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

VKV Amerikan Hastanesi

Istanbul, Sisli, 34365, Turkey (Türkiye)

About this study

Interscalene block is still the gold standard in shoulder surgery analgesia. The most important side effect is diaphragm paralysis due to the phrenic nerve being affected. It may cause symptomatic dyspnea, especially in patients with limited respiratory capacity. More distal brachial plexus blocks have been defined to avoid diaphragmatic paralysis . Thus, it is aimed to apply the local anesthetic drug further from the phrenic nerve. With the application of ultrasound, the amount of local anesthetic drug was reduced to less than 20 ml.

There are studies showing that an effective analgesia, as much as the interscalene block can do, can be provided by blocking the suprascapular nerve in the neck region. Although it has been shown in a cadaver study that the phrenic nerve can be stained after anterior suprascapular nerve block, the clinical effect is not fully known.

The effect of continuous local anesthetic drug administration on respiratory muscles through catheters placed in the peripheral nerve is another matter of concern. The method that will not affect the phrenic nerve at all and at the same time provide an effective analgesia is still under investigation.

The aim of our study is to show that the anterior suprascapular block applied with ultra-low volume (5ml) in shoulder arthroscopy operations is at least as effective as the interscalene block and does not cause diaphragm paralysis. One of the questions that our research aims to answer is how the continuous application of local anesthetic drugs affects the diaphragm muscle with the insertion of catheters in both regions.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients > 18 years old
  • American Society of Anesthesiology (ASA) score of 1-3
  • Scheduled for elective surgery.

Exclusion criteria

  • Patients with a condition that prevents peripheral nerve block
  • Coagulopathies
  • Chronic opioid use
  • Stroke
  • Polyneuropathy
  • Cognitive dysfunction
  • Communication difficulties
  • Allergies to drugs used

Treatment and study plan

Evaluation of Diaphragm Movement

Other

Diaphragmatic movement will be evaluated with ultrasonography and a 5-2 MHz convex transducer will be used. The ultrasound probe is placed between the mid-clavicular line and the anterior axillary line by directing it vertically and slightly cranially. During quiet breathing and deep breathing, diaphragm movement will be measured. The reduction in diaphragm motion will be calculated as the difference (in percent) in diaphragm motion measured before and 30 minutes after the block. Each test will be done 3 times and the values will be averaged. A decrease between 75% and 100% will be defined as complete paresis, a decrease between 25% and 75% as partial paresis, and less than 25% decrease in diaphragmatic movement will be defined as no paresis. In order to investigate the effect of continuous local anesthetic drug administration on diaphragm movement via nerve catheter, the same procedure will be repeated 24 hours after surgery.

Primary outcomes

  1. Pain rating

    Time frame: the first postoperative 30 minutes

    Measured by VAS. Postoperative 30 minutes

  2. Pain rating

    Time frame: Postoperative 6 hours

    Measured by VAS. Postoperative 6 hours

  3. Pain rating

    Time frame: Postoperative 12 hours

    Measured by VAS. Postoperative 12 hours

Secondary outcomes

  1. Diaphragmatic movements

    Time frame: 30 minutes after the block application.

    Diaphragmatic movement will be evaluated with ultrasound. 30 minutes after the block application.

  2. Diaphragmatic movements

    Time frame: At the first postoperative 24 hours

    Diaphragmatic movement will be evaluated with ultrasound. 24 hours after the block application.

Sponsors and collaborators

Lead sponsor

Alper Tunga Dogan

Other

Registry information

Official study title

Anterior Suprascapular Nerve Block is as Effective as Interscalene Nerve Block and Causes Less Diapragm Paralysis in Arthroscopic Shoulder Surgery

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 13, 2020
Registry last updated
Nov 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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