Upper Trunk Block Versus Costoclavicular Block For Arthroscopic Shoulder Surgery

Shoulder Pain Clinical Trial

Official title:

Comparison of Perioperative Analgesic Efficacy of Ultrasonography Guided Upper Trunk Block and Costoclavicular Infraclavicular Brachial Plexus Block in Arthroscopic Shoulder Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04194385
• Other study ID #: 71306642-050-05-04-
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Paralysis
• Phrenic Nerve Paralysis
• Shoulder Pain

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