Interscalene Versus Costoclavicular Blocks for Shoulder Surgery

NCT ID: NCT06953947

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-03-16

Brief Summary

AIM: Shoulder surgeries are among the most painful surgical procedures in orthopedic practice. Interscalene brachial plexus block, although the most commonly utilized regional anesthesia technique for alleviating pain following shoulder surgery, may result in complications such as hemidiaphragmatic paresis, hoarseness. More distal blocks along the brachial plexus may provide postoperative analgesia while potentially having less effect on respiratory functions. The aim of this study is to determine whether there are differences in postoperative pain scores and opioid consumption between interscalene block (ISB) and costoclavicular brachial plexus block (CCB).

MATERIALS AND METHODS: Following ethical approval, all eligible patients undergoing for shoulder surgery under general anesthesia between 01.11.2022 and 01.11.2023 will be enrolled and to be divided into two groups following written informed consent, with one group receiving ISB and the other group receiving CCB. A blinded researcher will record pain scores at postoperative 0.5, 1, 6, 12, 18, and 24 hours. Demographic data of patients, postoperative opioid consumption, time to first analgesic request, rescue analgesic requirements, adverse effects and hemodynamic parameters will be compared statistically.

Conditions

Postoperative Pain; Shoulder Surgeries Operations; Regional Anesthesia; Costoclavicular Block; Interscalene Blocks

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group CCB

The group of patients which received costoclavicular block

Group Type: EXPERIMENTAL

Costoclavicular block

Intervention Type: PROCEDURE

The costoclavicular block was first described by Karmakar et al. in 2015. It is a type of brachial plexus block that targets the three cords located lateral to the axillary artery within the costoclavicular space. The costoclavicular space is defined as the area between the middle third of the clavicle and the anterior thoracic wall. Within this space, the cords of the brachial plexus are situated lateral to the axillary artery, positioned between the pectoralis major, subclavius, and serratus anterior muscles.

In contrast to the traditional infraclavicular approach, the cords in the costoclavicular block are located more superficially and are more consistently clustered lateral to the axillary artery, which may facilitate visualization and needle targeting. After the needle is placed between the three cords under ultrasound guidance, the local anesthetic (20 mL of 0.25% bupivacaine) is injected.

Costoclavicular block

Intervention Type: DRUG

In costoclavicular block, the course of the three cords of the brachial plexus is visualized under ultrasound guidance, adjacent to the brachial artery beneath the clavicle. Subsequently, after the needle is placed under ultrasound guidance between the three cords, 20 mL of 0.25% bupivacaine is injected as the local anesthetic.

Group ISB

The group of patients which received interscalene block

Group Type: EXPERIMENTAL

Interscalene block

Intervention Type: PROCEDURE

Originally described by Etienne in 1925, the technique was later refined into its modern clinical form by Alon Winnie in 1970. The interscalene approach, primarily preferred for shoulder surgeries, aims to target the upper roots of the brachial plexus (C5-C7). In interscalene block, a needle is placed under ultrasound guidance around the upper and middle trunks of the brachial plexus, which pass through the space between the anterior and middle scalene muscles, and the local anesthetic (20 mL of 0.25% bupivacaine) is injected while its spread is observed.

Interscalene Nerve Block

Intervention Type: DRUG

In interscalene block, using an ultrasound probe placed on the neck, the course of the brachial plexus trunks between the anterior and middle scalene muscles is visualized. Then, after the needle is inserted under ultrasound guidance between the anterior and middle scalene muscles, 20 mL of 0.25% bupivacaine is injected as the local anesthetic.

Interventions

Costoclavicular block

The costoclavicular block was first described by Karmakar et al. in 2015. It is a type of brachial plexus block that targets the three cords located lateral to the axillary artery within the costoclavicular space. The costoclavicular space is defined as the area between the middle third of the clavicle and the anterior thoracic wall. Within this space, the cords of the brachial plexus are situated lateral to the axillary artery, positioned between the pectoralis major, subclavius, and serratus anterior muscles.

In contrast to the traditional infraclavicular approach, the cords in the costoclavicular block are located more superficially and are more consistently clustered lateral to the axillary artery, which may facilitate visualization and needle targeting. After the needle is placed between the three cords under ultrasound guidance, the local anesthetic (20 mL of 0.25% bupivacaine) is injected.

Intervention Type: PROCEDURE

Interscalene block

Originally described by Etienne in 1925, the technique was later refined into its modern clinical form by Alon Winnie in 1970. The interscalene approach, primarily preferred for shoulder surgeries, aims to target the upper roots of the brachial plexus (C5-C7). In interscalene block, a needle is placed under ultrasound guidance around the upper and middle trunks of the brachial plexus, which pass through the space between the anterior and middle scalene muscles, and the local anesthetic (20 mL of 0.25% bupivacaine) is injected while its spread is observed.

Intervention Type: PROCEDURE

Costoclavicular block

In costoclavicular block, the course of the three cords of the brachial plexus is visualized under ultrasound guidance, adjacent to the brachial artery beneath the clavicle. Subsequently, after the needle is placed under ultrasound guidance between the three cords, 20 mL of 0.25% bupivacaine is injected as the local anesthetic.

Intervention Type: DRUG

Interscalene Nerve Block

In interscalene block, using an ultrasound probe placed on the neck, the course of the brachial plexus trunks between the anterior and middle scalene muscles is visualized. Then, after the needle is inserted under ultrasound guidance between the anterior and middle scalene muscles, 20 mL of 0.25% bupivacaine is injected as the local anesthetic.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients undergoing unilateral shoulder surgery
• ASA (American Society of Anesthesiology) class I, II and III patients

Exclusion Criteria

• Coagulopathy
• Chronic Pulmoner Disease
• Hypersensitivity to local anesthetics
• Ipsilateral neurological deficits
• Non-communicative patients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sakarya University

OTHER

Sponsor Role: lead

Responsible Party

Muhammed Halit Tekeci, MD

Anesthesiology and Reanimation Specialist, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sakarya University Training and Research Hospital

Sakarya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-16214662-050.01.04-176689116

Identifier Type: -

Identifier Source: org_study_id