- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06953947
Interscalene Versus Costoclavicular Blocks for Shoulder Surgery
A Comparison Between Interscalene and Costoclavicular Blocks for Pain Relief After Shoulder Surgery
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Sakarya, Turkey, 54290
- Sakarya University Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group CCB
The group of patients which received costoclavicular block
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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.
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.
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Experimental: Group ISB
The group of patients which received interscalene block
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Measurement
Time Frame: Measured at Postoperative 0.5, 1, 6, 12, 18, and 24 hours
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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.
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Measured at Postoperative 0.5, 1, 6, 12, 18, and 24 hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Postoperative Opioid Consumption
Time Frame: Postoperative 24 hours.
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The total amount of opioid analgesics used which measured by the patient controlled analgesia (PCA) device for the postoperative 24 hours
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Postoperative 24 hours.
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Time to first analgesic request
Time Frame: Postoperative 24 hours
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The period of time which describes the patient's first postoperative analgesic request.
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Postoperative 24 hours
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Rescue analgesic requirements
Time Frame: Postoperative 24 hours
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The drugs that used for additinoal analgesia.
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Postoperative 24 hours
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Adverse effects
Time Frame: Postoperative 24 hours
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Any adverse effects related to anesthetic and analgesic procedures.
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Postoperative 24 hours
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-16214662-050.01.04-176689116
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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