Upper Trunk Block Versus Costoclavicular Block For Arthroscopic Shoulder Surgery

NCT ID: NCT04194385

Last Updated: 2023-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-10

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Shoulder Pain Phrenic Nerve Paralysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Upper trunk block

In the supraclavicular region, UTB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.

Group Type ACTIVE_COMPARATOR

Upper trunk block

Intervention Type PROCEDURE

Block will be applied to supraclavicular zone by 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine .

Diaphragmatic function assessment

Intervention Type PROCEDURE

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

Cervical plexus blockade

Intervention Type PROCEDURE

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

Costoclavicular brachial plexus block

In the infraclavicular region, CCBPB will be applied with 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.

Group Type ACTIVE_COMPARATOR

Costoclavicular block

Intervention Type PROCEDURE

Block will be applied to infraclavicular zone by 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.

Diaphragmatic function assessment

Intervention Type PROCEDURE

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

Cervical plexus blockade

Intervention Type PROCEDURE

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

Interventions

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Upper trunk block

Block will be applied to supraclavicular zone by 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine .

Intervention Type PROCEDURE

Costoclavicular block

Block will be applied to infraclavicular zone by 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.

Intervention Type PROCEDURE

Diaphragmatic function assessment

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

Intervention Type PROCEDURE

Cervical plexus blockade

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

Intervention Type PROCEDURE

Other Intervention Names

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Upper trunk brachial plexus block Costoclavicular brachial plexus block Detection of diaphragmatic paralysis with ultrasound guidance Superficial cervical plexus blockade

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Serdar Yeşiltaş, Instructor

Role: PRINCIPAL_INVESTIGATOR

Bezmialem Vakif University

Locations

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Bezmialem Vakıf University

Istanbul, Fatih, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Serdar Yeşiltaş, Instructor

Role: CONTACT

+90 542 363 26 30

Facility Contacts

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Serdar Yeşiltaş, Assist.Prof

Role: primary

Other Identifiers

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71306642-050-05-04-

Identifier Type: -

Identifier Source: org_study_id

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