Shoulder ArthroscopyNCT06660875
Comparison of Postoperative Analgesic Efficacy of SPSIPB and Combination of IBPB and SCPB
A study testing Serratus posterior superior intercostal plane block and Interscalene brachial plexus block and superficial cervical plexus block in people with Shoulder Arthroscopy and İnterscalene Brachial Plexus Block, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Shoulder arthroscopy is one of the frequently performed surgical procedures today. After shoulder surgery, ensuring sufficent analgesia is necessary for both the patient's comfort and for the early and regular performance of the required postoperative rehabilitation exercises. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Arthroscopy, İnterscalene Brachial Plexus Block, Superficial Cervical Plexus Block
- What is being tested?
- Serratus posterior superior intercostal plane block and Interscalene brachial plexus block and superficial cervical plexus block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Nov 2024to 21 May 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years old
- American Society of Anesthesiologists (ASA) physical status I-II-III
- Body mass index 18 to 30 kg/m2
- Elective shoulder arthroscopy surgery
Who cannot join
- Under 18 and over 65
- ASA score IV and above
- Advanced co-morbidity
- History of bleeding diathesis
- BMI under 18 kg/m2 and over 30 kg/m2
- Patient refusing the procedure
Show all 10Show fewer
- Patients who have previously undergone shoulder surgery
- Chronic opioid or analgesic use
- Patients who will operate under emergency conditions
- Patients who will not undergo shoulder surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Yenimahalle, Ankara, 06170
About this study
Official title: Comparison of Postoperative Analgesic Efficacy of Serratus Posterior Superıor Intercostal Plane Block and Combination of Interscalene Brachial Plexus Block and Superfisial Plexus Block in Shoulder Arthroscopies
Shoulder arthroscopy is one of the frequently performed surgical procedures today. After shoulder surgery, ensuring sufficent analgesia is necessary for both the patient's comfort and for the early and regular performance of the required postoperative rehabilitation exercises. Nerve blocks provide better pain control, opioid consumption in the postoperative period, and consequently have advantages such as fewer side effects and lower risks of pulmonary and cardiac complications. Multimodal analgesia approach is preferred for patients undergoing shoulder arthroscopy. Along with intravenous analgesic agents, peripheral nerve blocks (applied to every suitable and consenting patient) are performed based on patient preference. This study aims to compare the analgesic efficacy in the postoperative period of patients undergoing shoulder arthroscopy with a combination of interscalene brachial plexus block and superficial cervical plexus block with serratus posterior superior intercostal plane block.
- Conditions
- Shoulder Arthroscopy, İnterscalene Brachial Plexus Block, Superficial Cervical Plexus Block, Serratus Posterior Superior Intercostal Plane Block
- Being tested
- Serratus posterior superior intercostal plane block, Interscalene brachial plexus block and superficial cervical plexus block
- Keywords
- Remifantanile conception, Acute pain, Postoperatif pain
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serratus posterior superior intercostal plane blockDrug
Serratus posterior superior intercostal plane block is performed, under US guidance, before the surgical operation, and the induction of anesthesia, and when the patient is placed in the prone position.
Interscalene brachial plexus block and superficial cervical plexus blockDrug
İnterscalene brachial plexus block and superficial cervical plexus block is performed, under US guidance, before the surgical operation, and the induction of anesthesia, and when the patient is placed in the prone position.
| Study group | Role | What they receive |
|---|---|---|
| Serratus posterior superior intercostal plane block | Active comparator | With the patient in the prone position the skin is disinfected .Linear USG probe is placed on the spine of the scapula using an in-plane technique and moved medially. The 3rd rib is identified just on the medial scapular border. After visualizing the trapezius, rhomboid major, and serratus posterior superior muscles (from top to bottom) under USG guidance, a 22-G X 80-mm block needle is directed caudally and advanced until it contacted the rib. To confirm and obtain a plane between the serratus posterior superior and intercostal muscles, hydrodissection is performed using 2 ml of isotonic solution. After the needle site is confirmed, 30 ml of 0.25% bupivacaine is injected ; the local anesthetic spread is confirmed by USG. Receives: Drug: Serratus posterior superior intercostal plane block |
| Interscalene brachial plexus block and superficial cervical plexus block | Active comparator | İBPB:While the patient is in the supine position, the ultrasound probe is placed on the cricoid cartilage and moved laterally to visualize the trachea, thyroid, carotid artery, internal jugular vein, and sternocleidomastoid muscle. The brachial plexus is identified by directing it posteriorly and laterally between the anterior and middle scalene muscles. After entering between the roots using the in-plane technique and confirming the location with a 2 ml isotonic sodium injection, 20 ml of 0.25% bupivacaine is injected.
SCPB:While the patient is in the supine position, the ultrasound probe is placed at the midpoint of the sternocleidomastoid (SCM) muscle. The cervical plexus is visualized deep to the posterior border of the SCM muscle. The needle is inserted deep to the SCM, directed towards the levator scapula. After confirming the location with a 2 ml isotonic sodium injection, 10 ml of 0.25% bupivacaine is injected. Receives: Drug: Interscalene brachial plexus block and superficial cervical plexus block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative remifentanil consumption
The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded
Measured: During The intraoperatif period
Secondary outcomes (1)
Pain scores
Pain will be assessed at rest and while movement using the from 0 (no pain) to 10 (worst pain). Pain assessment will be done at the 1st, 2nd, 4th, 12th, and 24th hours after surgery
Measured: First 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start11 Nov 2024
- Primary completion11 May 2026
- Study completion21 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthroscopyStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muruvvet Taskir Turan, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660875
- Sponsor's protocol ID
- AEŞH-BADEK-1003-2024
- Status last verified
- Jul 2026
- First submitted
- 11 Oct 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Efficacy of Serratus Posterior Superıor Intercostal Plane Block and Combination of Interscalene Brachial Plexus Block and Superfisial Plexus Block in Shoulder Arthroscopies
- ClinicalTrials.gov ID
- NCT06660875
- Acronym / sponsor ID
- AEŞH-BADEK-1003-2024
- Conditions
- Shoulder Arthroscopy, İnterscalene Brachial Plexus Block, Superficial Cervical Plexus Block, Serratus Posterior Superior Intercostal Plane Block
- Keywords
- Remifantanile conception, Acute pain, Postoperatif pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 21 May 2026 (actual)
- First posted
- 28 Oct 2024 (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.
Shoulder arthroscopy is one of the frequently performed surgical procedures today. After shoulder surgery, ensuring sufficent analgesia is necessary for both the patient's comfort and for the early and regular performance of the required postoperative rehabilitation exercises. Nerve blocks provide better pain control, opioid consumption in the postoperative period, and consequently have advantages such as fewer side effects and lower risks of pulmonary and cardiac complications. Multimodal analgesia approach is preferred for patients undergoing shoulder arthroscopy. Along with intravenous analgesic agents, peripheral nerve blocks (applied to every suitable and consenting patient) are performed based on patient preference. This study aims to compare the analgesic efficacy in the postoperative period of patients undergoing shoulder arthroscopy with a combination of interscalene brachial plexus block and superficial cervical plexus block with serratus posterior superior intercostal plane block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus posterior superior intercostal plane block | Active comparator | Drug: Serratus posterior superior intercostal plane blockWith the patient in the prone position the skin is disinfected .Linear USG probe is placed on the spine of the scapula using an in-plane technique and moved medially. The 3rd rib is identified just on the medial scapular border. After visualizing the trapezius, rhomboid major, and serratus posterior superior muscles (from top to bottom) under USG guidance, a 22-G X 80-mm block needle is directed caudally and advanced until it contacted the rib. To confirm and obtain a plane between the serratus posterior superior and intercostal muscles, hydrodissection is performed using 2 ml of isotonic solution. After the needle site is confirmed, 30 ml of 0.25% bupivacaine is injected ; the local anesthetic spread is confirmed by USG. |
| Interscalene brachial plexus block and superficial cervical plexus block | Active comparator | Drug: Interscalene brachial plexus block and superficial cervical plexus blockİBPB:While the patient is in the supine position, the ultrasound probe is placed on the cricoid cartilage and moved laterally to visualize the trachea, thyroid, carotid artery, internal jugular vein, and sternocleidomastoid muscle. The brachial plexus is identified by directing it posteriorly and laterally between the anterior and middle scalene muscles. After entering between the roots using the in-plane technique and confirming the location with a 2 ml isotonic sodium injection, 20 ml of 0.25% bupivacaine is injected. SCPB:While the patient is in the supine position, the ultrasound probe is placed at the midpoint of the sternocleidomastoid (SCM) muscle. The cervical plexus is visualized deep to the posterior border of the SCM muscle. The needle is inserted deep to the SCM, directed towards the levator scapula. After confirming the location with a 2 ml isotonic sodium injection, 10 ml of 0.25% bupivacaine is injected. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 to 65 years old
- American Society of Anesthesiologists (ASA) physical status I-II-III
- Body mass index 18 to 30 kg/m2
- Elective shoulder arthroscopy surgery
Key exclusion criteria (10 listed)
- Under 18 and over 65
- ASA score IV and above
- Advanced co-morbidity
- History of bleeding diathesis
- BMI under 18 kg/m2 and over 30 kg/m2
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 |
|---|---|---|
| Serratus posterior superior intercostal plane blockSerratus posterior superior intercostal plane block is performed, under US guidance, before the surgical operation, and the induction of anesthesia, and when the patient is placed in the prone position. | Drug | Serratus posterior superior intercostal plane block |
| Interscalene brachial plexus block and superficial cervical plexus blockİnterscalene brachial plexus block and superficial cervical plexus block is performed, under US guidance, before the surgical operation, and the induction of anesthesia, and when the patient is placed in the prone position. | Drug | Interscalene brachial plexus block and superficial cervical plexus block |
Primary outcome
Intraoperative remifentanil consumption
Time frame: During The intraoperatif period
The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded
1 secondary outcome
Pain scores
Time frame: First 24 hours after surgery
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 6 Jul 2026.
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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 Serratus posterior superior intercostal plane block and Interscalene brachial plexus block and superficial cervical plexus block in people with Shoulder Arthroscopy and İnterscalene Brachial Plexus Block, run by Ankara Etlik City Hospital 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 4 inclusion and 10 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 6 Jul 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?
Intraoperative remifentanil consumption (time frame: During The intraoperatif period). 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 6 Jul 2026.