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

Anterior Suprascapular Nerve Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04626869
• Other study ID #: 2020.1234
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: November 2021
• Source: V.K.V. American Hospital, Istanbul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 1, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia, Arthroscopic Shoulder Surgery
• Anterior Suprascapular Nerve Block
• Diaphragm Paralysis Due to Local Anesthesia
• Paralysis
• Respiratory Paralysis

Intervention

Other:
• Evaluation of Diaphragm Movement
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.

Locations

Country	Name	City	State
Turkey	VKV Amerikan Hastanesi	Istanbul	Sisli

Sponsors (1)

Lead Sponsor	Collaborator
Alper Tunga Dogan

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Auyong DB, Hanson NA, Joseph RS, Schmidt BE, Slee AE, Yuan SC. Comparison of Anterior Suprascapular, Supraclavicular, and Interscalene Nerve Block Approaches for Major Outpatient Arthroscopic Shoulder Surgery: A Randomized, Double-blind, Noninferiority Tr — View Citation

Bansal V, Shastri U, Canlas C, Gadsden JC. Diaphragm-Sparing Nerve Blocks for Shoulder Surgery: An Alternative Approach. Reg Anesth Pain Med. 2017 Jul/Aug;42(4):544-545. doi: 10.1097/AAP.0000000000000606. — View Citation

Tran DQ, Layera S, Bravo D, Cristi-Sanchéz I, Bermudéz L, Aliste J. Diaphragm-sparing nerve blocks for shoulder surgery, revisited. Reg Anesth Pain Med. 2019 Sep 20. pii: rapm-2019-100908. doi: 10.1136/rapm-2019-100908. [Epub ahead of print] — View Citation

Wiegel M, Moriggl B, Schwarzkopf P, Petroff D, Reske AW. Anterior Suprascapular Nerve Block Versus Interscalene Brachial Plexus Block for Shoulder Surgery in the Outpatient Setting: A Randomized Controlled Patient- and Assessor-Blinded Trial. Reg Anesth P — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain rating	Measured by VAS. Postoperative 30 minutes	the first postoperative 30 minutes
Primary	Pain rating	Measured by VAS. Postoperative 6 hours	Postoperative 6 hours
Primary	Pain rating	Measured by VAS. Postoperative 12 hours	Postoperative 12 hours
Secondary	Diaphragmatic movements	Diaphragmatic movement will be evaluated with ultrasound. 30 minutes after the block application.	30 minutes after the block application.
Secondary	Diaphragmatic movements	Diaphragmatic movement will be evaluated with ultrasound. 24 hours after the block application.	At the first postoperative 24 hours