An interventional study of Upper trunk block and Costoclavicular block in Shoulder Pain and Phrenic Nerve Paralysis, sponsored by Bezmialem Vakif University. Status unknown at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-04-05.
Sponsored by Bezmialem Vakif University · Not applicable, Interventional, and Treatment
Interscalene brachial plexus block is known as the gold standard for analgesia after shoulder surgery, but limits the use of ipsilateral phrenic nerve paralysis. Recently, interest in potential diaphragm-sparing alternative blocks has increased for patients undergoing shoulder surgery.Two of these blocks are upper trunk block (UTB) and costoclavicular brachial plexus (CCBPB) block. This randomized controlled trial will compare ultrasound-guided UTB and CCBPB in patients undergoing arthroscopic shoulder surgery.
The main outcome is pain intensity score at 30 minutes after arrival in the post anesthesia care unit (PACU) as measured by a numerical rating scale (NRS) from 0 to 10. The investigators research hypothesis is that UTB and CCBPB will result in equivalent postoperative analgesia at 30 minutes in the PACU.
724 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 577 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Bezmialem Vakif University is the lead sponsor of 351 studies on the registry; 57 are open to participants now.
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In the supraclavicular region, UTB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.
Procedure: Upper trunk block · Procedure: Diaphragmatic function assessment · Procedure: Cervical plexus blockade
In the infraclavicular region, CCBPB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.
Procedure: Costoclavicular block · Procedure: Diaphragmatic function assessment · Procedure: Cervical plexus blockade
Block will be applied to supraclavicular zone by 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine .
Also known as: Upper trunk brachial plexus block
Block will be applied to infraclavicular zone by 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.
Also known as: Costoclavicular brachial plexus block
Diaphragmatic excursion will be assessed under ultrasound immediately before and after regional anesthesia.
Also known as: Detection of diaphragmatic paralysis with ultrasound guidance
Block will be applied at thyroid cartilage level via 10 ml % 0.25 bupivacaine.
Also known as: Superficial cervical plexus blockade
Detection of diaphragmatic paralysis by ultrasonography
Ipsilateral diaphragmatic excursion 30 minutes after block completion
Time frame: 30 minutes after block application
Postoperative opioid consumption
Total amount of tramadol consumption during the first 24 hours after surgery. Patient controlled analgesia to be inserted.
Time frame: 24 hour after surgery
Pain intensity score
Postoperative pain assessed with verbal rating scale (VRS 0: no pain 10:pain as bad as can be )
Time frame: 30 minutes, 1,3, 6, 12, 24 hour after surgery
Block perform time
Block application time will be recorded
Time frame: The time from the needle enters the skin until the block is completed
Block onset time
Block onset time will be evaluated and recorded.
Time frame: Until sensory and motor block occurs
Intraoperative fentanyl requirement
During the operation, 0.5 μg/kg fentanyl was administered to the patient in case of a 20% increase in the mean blood pressure and heart rate compared to the baseline values
Time frame: From the beginning to the end of the operation
Patient satisfaction: NRS
Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 =very satisfied)
Time frame: 24 hour after surgery
Started May 2020 (actual). Primary completion is estimated for May 2023, 36 months after the start.
Of 327 non-industry interventional studies with no phase under Shoulder Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's planned 36 months is above that.
Counting every sponsor, half of 336 studies reached it within 11 months; a quarter within 5 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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