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

NCT04626869 | Completed Phase 4

• 1 other identifier: 2020.1234
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

arthroscopic shoulder surgery; Interscalene nerve block; Anterior suprascapular nerve block; Analgesia, postoperative; Diaphragm paralysis

Outcome Measures

Primary Outcomes (3)

• Pain rating

  Measured by VAS. Postoperative 30 minutes

  the first postoperative 30 minutes

• Pain rating

  Measured by VAS. Postoperative 6 hours

  Postoperative 6 hours

• Pain rating

  Measured by VAS. Postoperative 12 hours

  Postoperative 12 hours

Secondary Outcomes (2)

• Diaphragmatic movements

  30 minutes after the block application.

• Diaphragmatic movements

  At the first postoperative 24 hours

Study Arms (2)

Interscalene block

ACTIVE COMPARATOR

patients will be placed in a semi-sitting position with their heads facing the opposite side. Linear ultrasound probe (GE Loqic P9 7-15 MHz) to detect the brachial plexus. At the cervical level 5-6, the posterior brachial plexus will be approached as "in-plane" from the posterior with the needle (Contiplex C, Braun) through the catheter. The nerve structure will be confirmed with stimulation in the upper extremity muscles with a nerve stimulator and 5 ml 0.5% Bupivacaine will be injected.

Other: Evaluation of Diaphragm Movement

Anterior suprascapular nerve block

ACTIVE COMPARATOR

patients will be placed in a semi-sitting position with their heads facing the opposite side. Linear ultrasound probe (GE Loqic P9 7-15 MHz) will be placed in the suprascapular region in a coronal oblique manner. The omohyoid muscle, under it the suprascapular nerve, the brachial plexus and the subclavian artery will be identified. The suprascapular nerve will be approached from the posterior as "in-plane" with a needle (Contiplex C, Braun) through the catheter. The nerve structure will be confirmed by stimulation in the supraspinous muscle with a nerve stimulator and 5 ml 0.5% Bupivacaine will be injected.

Other: Evaluation of Diaphragm Movement

Interventions

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.

Anterior suprascapular nerve block; Interscalene block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Alper Tunga Dogan: lead

Study Sites (1)

VKV Amerikan Hastanesi

Istanbul, Sisli, 34365, Turkey (Türkiye)

Location

Related Publications (4)

• Tran DQ, Layera S, Bravo D, Cristi-Sanchez I, Bermudez L, Aliste J. Diaphragm-sparing nerve blocks for shoulder surgery, revisited. Reg Anesth Pain Med. 2019 Sep 20:rapm-2019-100908. doi: 10.1136/rapm-2019-100908. Online ahead of print.

  PMID: 31541010 RESULT

• 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. No abstract available.

  PMID: 28632682 RESULT

• 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 Trial. Anesthesiology. 2018 Jul;129(1):47-57. doi: 10.1097/ALN.0000000000002208.

  PMID: 29634491 RESULT

• 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 Pain Med. 2017 May/Jun;42(3):310-318. doi: 10.1097/AAP.0000000000000573.

  PMID: 28257388 RESULT

MeSH Terms

Conditions

Agnosia; Respiratory Paralysis

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Paralysis

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Diaphragm Measurements will be done by an expert unaware of the working groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiology specialist

Model Details: The patients will be divided into two groups as patients who underwent suprascapular nerve block with the supraclavicular approach and patients who underwent conventional interscalene nerve block. 5 ml of 0.5% Bupivacaine will be injected into both groups. Diaphragmatic movement will be evaluated with ultrasound at the right and left subcostal border with the patients in a semi-sitting position. The reduction in diaphragm motion will be calculated as the difference (in percent) in diaphragm motion measured before and 30 minutes after the block.

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: November 13, 2020
• Study Start: December 1, 2020
• Primary Completion: March 15, 2021
• Study Completion: April 1, 2021
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)