NCT06953947

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

1.5 years

First QC Date

April 5, 2025

Last Update Submit

April 29, 2025

Conditions

Keywords

analgesiabrachial plexuspostoperative painshoulder surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain Measurement

    The pain measurements of the patients after surgery which evaluated with visual analogue scale (VAS), ranging from 0 to 10 while 0 describes no pain at all and 10 describes the most severe pain a person can experience.

    Measured at Postoperative 0.5, 1, 6, 12, 18, and 24 hours

Secondary Outcomes (4)

  • Postoperative Opioid Consumption

    Postoperative 24 hours.

  • Time to first analgesic request

    Postoperative 24 hours

  • Rescue analgesic requirements

    Postoperative 24 hours

  • Adverse effects

    Postoperative 24 hours

Study Arms (2)

Group CCB

EXPERIMENTAL

The group of patients which received costoclavicular block

Procedure: Costoclavicular blockDrug: Costoclavicular block

Group ISB

EXPERIMENTAL

The group of patients which received interscalene block

Procedure: Interscalene blockDrug: Interscalene Nerve Block

Interventions

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.

Group CCB

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.

Group ISB

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.

Group ISB

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University Training and Research Hospital

Sakarya, 54290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
A blinded researcher recorded pain scores at postoperative 0.5, 1, 6, 12, 18, and 24 hours
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A total of 62 patients undergoing for shoulder surgery under general anesthesia between 01.11.2022 and 01.11.2023 were divided into two groups following written informed consent, with one group receiving ISB and the other group receiving CCB. A blinded researcher recorded pain scores at postoperative 0.5, 1, 6, 12, 18, and 24 hours
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation Specialist, M.D.

Study Record Dates

First Submitted

April 5, 2025

First Posted

May 1, 2025

Study Start

October 1, 2022

Primary Completion

March 15, 2024

Study Completion

March 16, 2024

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations