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

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Evaluation of Diaphragm Movement
Sponsored by
Alper Tunga Dogan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diaphragm Paralysis Due to Local Anesthesia focused on measuring arthroscopic shoulder surgery, Interscalene nerve block, Anterior suprascapular nerve block, Analgesia, postoperative, Diaphragm paralysis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VKV Amerikan Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Interscalene block

Anterior suprascapular nerve block

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain rating
Measured by VAS. Postoperative 30 minutes
Pain rating
Measured by VAS. Postoperative 6 hours
Pain rating
Measured by VAS. Postoperative 12 hours

Secondary Outcome Measures

Diaphragmatic movements
Diaphragmatic movement will be evaluated with ultrasound. 30 minutes after the block application.
Diaphragmatic movements
Diaphragmatic movement will be evaluated with ultrasound. 24 hours after the block application.

Full Information

First Posted
September 16, 2020
Last Updated
November 28, 2021
Sponsor
Alper Tunga Dogan
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1. Study Identification

Unique Protocol Identification Number
NCT04626869
Brief Title
Anterior Suprascapular Nerve Block is an Effective and Diaphragm Protective Approach for Arthroscopic Shoulder Surgery
Official Title
Anterior Suprascapular Nerve Block is as Effective as Interscalene Nerve Block and Causes Less Diapragm Paralysis in Arthroscopic Shoulder Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
March 15, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alper Tunga Dogan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
Diaphragm Measurements will be done by an expert unaware of the working groups.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interscalene block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Anterior suprascapular nerve block
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Evaluation of Diaphragm Movement
Intervention Description
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 Outcome Measure Information:
Title
Pain rating
Description
Measured by VAS. Postoperative 30 minutes
Time Frame
the first postoperative 30 minutes
Title
Pain rating
Description
Measured by VAS. Postoperative 6 hours
Time Frame
Postoperative 6 hours
Title
Pain rating
Description
Measured by VAS. Postoperative 12 hours
Time Frame
Postoperative 12 hours
Secondary Outcome Measure Information:
Title
Diaphragmatic movements
Description
Diaphragmatic movement will be evaluated with ultrasound. 30 minutes after the block application.
Time Frame
30 minutes after the block application.
Title
Diaphragmatic movements
Description
Diaphragmatic movement will be evaluated with ultrasound. 24 hours after the block application.
Time Frame
At the first postoperative 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
VKV Amerikan Hastanesi
City
Istanbul
State/Province
Sisli
ZIP/Postal Code
34365
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31541010
Citation
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.
Results Reference
result
PubMed Identifier
28632682
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. No abstract available.
Results Reference
result
PubMed Identifier
29634491
Citation
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.
Results Reference
result
PubMed Identifier
28257388
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 Pain Med. 2017 May/Jun;42(3):310-318. doi: 10.1097/AAP.0000000000000573.
Results Reference
result

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

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