A Phase 4 interventional study of Evaluation of Diaphragm Movement in Diaphragm Paralysis Due to Local Anesthesia, Anterior Suprascapular Nerve Block and Analgesia, Arthroscopic Shoulder Surgery, sponsored by Alper Tunga Dogan. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-30.
Sponsored by Alper Tunga Dogan · Phase 4, Interventional, and Treatment
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.
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.
37 studies on the registry are indexed under Respiratory Paralysis; 7 are open to participants now.
This study's enrollment of 50 is close to the median of 48 across 19 interventional studies indexed under Respiratory Paralysis.
Browse Respiratory Paralysis studies →This is the only study on the registry with Alper Tunga Dogan as lead sponsor.
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Exclusion Criteria:
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
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
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.
Pain rating
Measured by VAS. Postoperative 30 minutes
Time frame: the first postoperative 30 minutes
Pain rating
Measured by VAS. Postoperative 6 hours
Time frame: Postoperative 6 hours
Pain rating
Measured by VAS. Postoperative 12 hours
Time frame: Postoperative 12 hours
Diaphragmatic movements
Diaphragmatic movement will be evaluated with ultrasound. 30 minutes after the block application.
Time frame: 30 minutes after the block application.
Diaphragmatic movements
Diaphragmatic movement will be evaluated with ultrasound. 24 hours after the block application.
Time frame: At the first postoperative 24 hours
Plan to share: No
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