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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04194385
Other study ID # 71306642-050-05-04-
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 10, 2020
Est. completion date June 2023

Study information

Verified date April 2023
Source Bezmialem Vakif University
Contact Serdar Yesiltas, Instructor
Phone +90 542 363 26 30
Email syesiltas@bezmialem.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 2023
Est. primary completion date May 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. American Association of Anesthesiologists (ASA) physical status I - III 2. BMI 20 to 35 kg / m2 3. Patients scheduled for elective arthroscopic shoulder surgery Exclusion Criteria: 1. Patients who refuse to participate in the study, 2. Pre-existing (obstructive or restrictive) lung disease, 3. Coagulopathy, 4. Sepsis, 5. Hepatic or renal insufficiency, 6. Pregnancy 7. Allergy to local anesthetic drugs, 8. Chronic pain condition requiring opioid intake at home, 9. Surgery in the neck or infraclavicular region 10. BMI above 40. 11. History of psychiatric diseases needing treatment. 12. Failure of nerve block performed in the preoperative block room 13. Substance abuse history

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Upper trunk block
Block will be applied to supraclavicular zone by 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine .
Costoclavicular block
Block will be applied to infraclavicular zone by 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.
Diaphragmatic function assessment
Diaphragmatic excursion will be assessed under ultrasound immediately before and after regional anesthesia.
Cervical plexus blockade
Block will be applied at thyroid cartilage level via 10 ml % 0.25 bupivacaine.

Locations

Country Name City State
Turkey Bezmialem Vakif University Istanbul Fatih

Sponsors (1)

Lead Sponsor Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Detection of diaphragmatic paralysis by ultrasonography Ipsilateral diaphragmatic excursion 30 minutes after block completion 30 minutes after block application
Secondary Postoperative opioid consumption Total amount of tramadol consumption during the first 24 hours after surgery. Patient controlled analgesia to be inserted. 24 hour after surgery
Secondary Pain intensity score Postoperative pain assessed with verbal rating scale (VRS 0: no pain 10:pain as bad as can be ) 30 minutes, 1,3, 6, 12, 24 hour after surgery
Secondary Block perform time Block application time will be recorded The time from the needle enters the skin until the block is completed
Secondary Block onset time Block onset time will be evaluated and recorded. Until sensory and motor block occurs
Secondary 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 From the beginning to the end of the operation
Secondary Patient satisfaction: NRS Patient satisfaction measured using a NRS 0 to 10 (0 = unsatisfied; 10 =very satisfied) 24 hour after surgery
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