Postoperative PainNCT06953947
Interscalene Versus Costoclavicular Blocks for Shoulder Surgery
A study testing Costoclavicular block, Interscalene block and Interscalene Nerve Block in people with Postoperative Pain and Shoulder Surgeries Operations, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain, Shoulder Surgeries Operations, Regional Anesthesia
- What is being tested?
- Costoclavicular block, Interscalene block and Interscalene Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 16 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing unilateral shoulder surgery
- ASA (American Society of Anesthesiology) class I, II and III patients
Who cannot join
- Coagulopathy
- Chronic Pulmoner Disease
- Hypersensitivity to local anesthetics
- Ipsilateral neurological deficits
- Non-communicative patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University Training and Research Hospital
Sakarya, 54290
About this study
Official title: 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.
- Conditions
- Postoperative Pain, Shoulder Surgeries Operations, Regional Anesthesia, Costoclavicular Block, Interscalene Blocks
- Being tested
- Costoclavicular block, Interscalene block, Interscalene Nerve Block
- Keywords
- analgesia, brachial plexus, postoperative pain, shoulder surgery
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Costoclavicular blockProcedure or surgery
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.
Interscalene blockProcedure or surgery
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.
Costoclavicular blockDrug
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.
Interscalene Nerve BlockDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group CCB | Experimental | The group of patients which received costoclavicular block Receives: Procedure: Costoclavicular block; Drug: Costoclavicular block |
| Group ISB | Experimental | The group of patients which received interscalene block Receives: Procedure: Interscalene block; Drug: Interscalene Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured at Postoperative 0.5, 1, 6, 12, 18, and 24 hours
Secondary outcomes (4)
Postoperative Opioid Consumption
The total amount of opioid analgesics used which measured by the patient controlled analgesia (PCA) device for the postoperative 24 hours
Measured: Postoperative 24 hours.
Time to first analgesic request
The period of time which describes the patient's first postoperative analgesic request.
Measured: Postoperative 24 hours
Rescue analgesic requirements
The drugs that used for additinoal analgesia.
Measured: Postoperative 24 hours
Adverse effects
Any adverse effects related to anesthetic and analgesic procedures.
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Oct 2022
- Primary completion1 Nov 2023
- Study completion16 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Halit Tekeci, MD, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953947
- Sponsor's protocol ID
- E-16214662-050.01.04-176689116
- Status last verified
- Apr 2025
- First submitted
- 5 Apr 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Interscalene and Costoclavicular Blocks for Pain Relief After Shoulder Surgery
- ClinicalTrials.gov ID
- NCT06953947
- Acronym / sponsor ID
- E-16214662-050.01.04-176689116
- Conditions
- Postoperative Pain, Shoulder Surgeries Operations, Regional Anesthesia, Costoclavicular Block, Interscalene Blocks
- Keywords
- analgesia, brachial plexus, postoperative pain, shoulder surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 16 Mar 2024 (actual)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Group CCB | Experimental | Procedure: Costoclavicular block, Drug: Costoclavicular blockThe group of patients which received costoclavicular block |
| Group ISB | Experimental | Procedure: Interscalene block, Drug: Interscalene Nerve BlockThe group of patients which received interscalene block |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing unilateral shoulder surgery
- ASA (American Society of Anesthesiology) class I, II and III patients
Key exclusion criteria (5 listed)
- Coagulopathy
- Chronic Pulmoner Disease
- Hypersensitivity to local anesthetics
- Ipsilateral neurological deficits
- Non-communicative patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Costoclavicular blockThe 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. | Procedure or surgery | Group CCB |
| Interscalene blockOriginally 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. | Procedure or surgery | Group ISB |
| Costoclavicular blockIn 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. | Drug | Group CCB |
| Interscalene Nerve BlockIn 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. | Drug | Group ISB |
Primary outcome
Postoperative Pain Measurement
Time frame: Measured at Postoperative 0.5, 1, 6, 12, 18, and 24 hours
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.
4 secondary outcomes
Postoperative Opioid Consumption
Time frame: Postoperative 24 hours.
Time to first analgesic request
Time frame: Postoperative 24 hours
Rescue analgesic requirements
Time frame: Postoperative 24 hours
Adverse effects
Time frame: Postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Costoclavicular block, Interscalene block and Interscalene Nerve Block in people with Postoperative Pain and Shoulder Surgeries Operations, run by Sakarya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Measurement (time frame: Measured at Postoperative 0.5, 1, 6, 12, 18, and 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.