Upper Trunk Block Versus Costoclavicular Block For Arthroscopic Shoulder Surgery

NCT04194385 | Unknown

• 1 other identifier: 71306642-050-05-04-
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Shoulder Pain; Phrenic Nerve Paralysis

Keywords

bupivacaine; costoclavicular block; upper trunk block

Outcome Measures

Primary Outcomes (1)

• Detection of diaphragmatic paralysis by ultrasonography

  Ipsilateral diaphragmatic excursion 30 minutes after block completion

  30 minutes after block application

Secondary Outcomes (6)

• Postoperative opioid consumption

  24 hour after surgery

• Pain intensity score

  30 minutes, 1,3, 6, 12, 24 hour after surgery

• Block perform time

  The time from the needle enters the skin until the block is completed

• Block onset time

  Until sensory and motor block occurs

• Intraoperative fentanyl requirement

  From the beginning to the end of the operation

Study Arms (2)

Upper trunk block

ACTIVE COMPARATOR

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

Costoclavicular brachial plexus block

ACTIVE COMPARATOR

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

Interventions

Upper trunk block PROCEDURE

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

Upper trunk block

Costoclavicular block PROCEDURE

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

Costoclavicular brachial plexus block

Diaphragmatic function assessment PROCEDURE

Diaphragmatic excursion will be assessed under ultrasound immediately before and after regional anesthesia.

Also known as: Detection of diaphragmatic paralysis with ultrasound guidance

Costoclavicular brachial plexus block; Upper trunk block

Cervical plexus blockade PROCEDURE

Block will be applied at thyroid cartilage level via 10 ml % 0.25 bupivacaine.

Also known as: Superficial cervical plexus blockade

Costoclavicular brachial plexus block; Upper trunk block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Association of Anesthesiologists (ASA) physical status I - III
• BMI 20 to 35 kg / m2
• Patients scheduled for elective arthroscopic shoulder surgery

You may not qualify if:

• Patients who refuse to participate in the study,
• Pre-existing (obstructive or restrictive) lung disease,
• Coagulopathy,
• Sepsis,
• Hepatic or renal insufficiency,
• Pregnancy
• Allergy to local anesthetic drugs,
• Chronic pain condition requiring opioid intake at home,
• Surgery in the neck or infraclavicular region
• BMI above 40.
• History of psychiatric diseases needing treatment.
• Failure of nerve block performed in the preoperative block room
• Substance abuse history

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Fatih, 34093, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Interventions

Cervical Plexus Block

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Serdar Yeşiltaş, Instructor

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serdar Yeşiltaş, Instructor

CONTACT

+90 542 363 26 30; syesiltas@bezmialem.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: May 10, 2020
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-04

Locations

TU (1)