Upper Trunk Block Versus Costoclavicular Block For Arthroscopic Shoulder Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Pain; Phrenic Nerve Paralysis
• Intervention / Treatment: Procedure: Upper trunk block; Procedure: Diaphragmatic function assessment; Procedure: Cervical plexus blockade; Procedure: Costoclavicular block

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Serdar Yeşiltaş, Instructor; Phone Number: +90 542 363 26 30; Email: syesiltas@bezmialem.edu.tr

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Recruiting
      • Bezmialem Vakıf University
      • Contact: Serdar Yeşiltaş, Assist.Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Upper trunk block; In the supraclavicular region, UTB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.	Procedure: Upper trunk block; Block will be applied to supraclavicular zone by 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine .; Other Names: Upper trunk brachial plexus block; Procedure: Diaphragmatic function assessment; Diaphragmatic excursion will be assessed under ultrasound immediately before and after regional anesthesia.; Other Names: Detection of diaphragmatic paralysis with ultrasound guidance; Procedure: Cervical plexus blockade; Block will be applied at thyroid cartilage level via 10 ml % 0.25 bupivacaine.; Other Names: Superficial cervical plexus blockade
Active Comparator: Costoclavicular brachial plexus block; In the infraclavicular region, CCBPB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.	Procedure: Diaphragmatic function assessment; Diaphragmatic excursion will be assessed under ultrasound immediately before and after regional anesthesia.; Other Names: Detection of diaphragmatic paralysis with ultrasound guidance; Procedure: Cervical plexus blockade; Block will be applied at thyroid cartilage level via 10 ml % 0.25 bupivacaine.; Other Names: Superficial cervical plexus blockade; Procedure: Costoclavicular block; Block will be applied to infraclavicular zone by 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.; Other Names: Costoclavicular brachial plexus block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of diaphragmatic paralysis by ultrasonography	Ipsilateral diaphragmatic excursion 30 minutes after block completion	30 minutes after block application

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Block perform time	Block application time will be recorded	The time from the needle enters the skin until the block is completed
Block onset time	Block onset time will be evaluated and recorded.	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	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)	24 hour after surgery

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2020
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: December 9, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 11, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: bupivacaine; costoclavicular block; upper trunk block
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Paralysis
• Other Study ID Numbers: 71306642-050-05-04-

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No