Postoperative PainNCT06973447
Combined ASSNB and ICBPB vs CCBPB in Shoulder Arthroscopy
A study testing Anterior suprascapular nerve block (ASSNB), Infraclavicular Brachial Plexus Block (ICBPB) and Costoclavicular brachial plexus block (CCBPB) in people with Postoperative Pain and Shoulder Arthroscopy, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim is to compare the postoperative analgesic and hemidiaphragmatic effects of Anterior SupraScapular Nerve Block (ASSNB) and InfraClavicular Brachial Plexus Block (ICBPB) combination versus CostoClavicular Brachial Plexus Block (CCBPB) in patients undergoing shoulder arthroscopic surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pain, Shoulder Arthroscopy
- What is being tested?
- Anterior suprascapular nerve block (ASSNB), Infraclavicular Brachial Plexus Block (ICBPB) and Costoclavicular brachial plexus block (CCBPB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2024to 30 Sep 2025
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients older than 18 years of age who underwent arthroscopic shoulder surgery under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.
Who cannot join
- patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with local anesthetic drug allergies,
- patients with unstable hemodynamics,
- patients who could not cooperate during postoperative pain assessment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sivas Cumhuriyet University
Sivas, Sivas, 58140
About this study
Official title: Comparison of the Effects of Combined Anterior Suprascapular Nerve Block and Infraclavicular Brachial Plexus Block Versus Costoclavicular Brachial Plexus Block on Postoperative Pain and Hemidiaphragmatic Paralysis in Shoulder Arthroscopy
The aim is to compare the postoperative analgesic and hemidiaphragmatic effects of Anterior SupraScapular Nerve Block (ASSNB) and InfraClavicular Brachial Plexus Block (ICBPB) combination versus CostoClavicular Brachial Plexus Block (CCBPB) in patients undergoing shoulder arthroscopic surgery.
Read the detailed description
Patients were divided into two randomized groups: Group 1 (ASSNB+ICBPB Combination group, n=15) and Group 2 (CCBPB group, n=15). All patients will receive the same standard general anesthesia per hospital protocol. All blocks will be applied with the same ultrasonography and block equipment, and by the same physician. Before the anesthesia induction, ipsilateral diaphragmatic excursion will be measured via Ultrasonography (USG). After the anesthesia induction, patients in Group 1 will receive anterior suprascapular nerve block (ASSNB) with 10 mL of 0.25% bupivacaine and infraclavicular brachial plexus block (ICBPB) with 15 mL of 0.25% bupivacaine (with a total volume of 25 mL). Patients in Group 2 will receive costoclavicular brachial plexus block (CCBPB) with 15 mL of 0.25% bupivacaine. All patients will receive Paracetamol 1gr and Dexketoprofen 50mg intravenous (IV) 10 minutes prior to skin closure. After 30 minutes of emergence from anesthesia (upon reaching 9 points on modified Aldrete scoring), ipsilateral diaphragmatic excursion will be assessed again. Pre- and postblock excursion differences will be recorded. Routine analgesic procedure consisting of 3x1gr Paracetamol and 2x50mg Dexketoprofen will be followed postoperatively for 24 hours. Numeric Rating Scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hours after the surgery. Quality of Recovery-15 Patient Survey will be done both preoperatively for a baseline score, and postoperatively at 24th hour to assess the quality of recovery from the patients' view. Tramadol 50mg IV will be administered as a rescue analgesic for all patients if NRS score is equal to or higher than 4. Total Tramadol consumption will be calculated.
- Conditions
- Postoperative Pain, Shoulder Arthroscopy
- Being tested
- Anterior suprascapular nerve block (ASSNB), Infraclavicular Brachial Plexus Block (ICBPB), Costoclavicular brachial plexus block (CCBPB)
- Keywords
- postoperative pain, shoulder arthroscopy, regional anesthesia, costoclavicular brachial plexus block, infraclavicular brachial plexus block, anterior suprascapular nerve block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior suprascapular nerve block (ASSNB)Procedure or surgery
10 mL of 0.25% bupivacaine
Infraclavicular Brachial Plexus Block (ICBPB)Procedure or surgery
15 mL of 0.25% bupivacaine
Costoclavicular brachial plexus block (CCBPB)Procedure or surgery
15 mL of 0.25% bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Combined ASSNB and ICBPB | Active comparator | For this group, ASSNB and ICBPB blocks will be performed on the ipsilateral side of the patient right after the anesthesia induction with the patients in supine position. For ICBPB, a high frequency linear transducer USG is placed over the lateral infraclavicular fossa in a sagittal orientation medial to the coracoid process and caudal to the clavicle. The block needle is inserted in-plane from a cephalad-to-caudal direction, just inferior to the clavicle to pass through the pectoralis major and minor muscles, aiming toward the posterior aspect of the axillary artery. 15 mL of 0.25% bupivacaine is administered. For ASSNB, the transducer is positioned in a sagittal oblique orientation over the supraclavicular fossa to image the subclavian artery and the brachial plexus. While tracing the plexus craniocaudally, the suprascapular nerve is identified. The needle is advanced in-plane from posterior to anterior. 10 mL of 0.25% bupivacaine is administered. Receives: Procedure: Anterior suprascapular nerve block (ASSNB); Procedure: Infraclavicular Brachial Plexus Block (ICBPB) |
| CCBPB | Active comparator | For this group, CCBPC will be performed on the ipsilateral side of the patient right after the anesthesia induction with the patients in supine position. For CCBPB, a high frequency linear transducer of the USG is placed in the medial infraclavicular fossa parallel and next to the clavicle to identify the axillary artery. The transducer is then tilted cephalad to image the brachial plexus and the artery in a perpendicular orientation between the subclavius muscle and the serratus anterior. The needle is advanced in-plane in a lateral-to-medial direction, adjusting the angle to reach the space in between the three cords. 15 mL of 0.25% bupivacaine is administered. Receives: Procedure: Costoclavicular brachial plexus block (CCBPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale (NRS) Scores
Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
Measured: Postoperative 24 hours
Diaphragmatic Excursion Difference
Ipsilateral diaphragmatic excursions will be measured both preoperatively right before the anesthesia induction, and postoperatively after 30 minutes of emergence from anesthesia (upon reaching 9 points on modified Aldrete scoring). A diaphragmatic excursion change of up to 25% indicates no nerve involvement, a change between 25%-75% indicates partial involvement, and a change exceeding 75% indicates complete involvement of the phrenic nerve.
Measured: Preoperatively right before the anesthesia induction, and postoperatively after 30 minutes of emergence from anesthesia (upon reaching 9 points on modified Aldrete scoring)
Secondary outcomes (2)
Quality of Recovery-15 Patient Survey (QoR-15)
The widespread use of minimally invasive interventions to reduce postoperative mortality and morbidity, combined with the implementation of Enhanced Recovery After Surgery (ERAS) protocols, has heightened overall interest in the postoperative recovery period and the importance of outcome evaluation. To address the emerging needs in this field, new tools prioritizing patient satisfaction have been developed alongside traditional scales that measure classical parameters. The Quality of Recovery-15 Patient Survey (QoR-15) stands out as one of the most up-to-date and reliable examples among these tools. The survey is done both preoperatively to record patients' baseline score, and postoperatively at 24th hour. Higher scores mean better quality of recovery after surgery. Mininum and maximum scores can be '0 (zero)' and '150 (one hundred and fifty)' respectively.
Measured: Preoperatively and Postoperatively at 24th hour
Total tramadol consumption
Postoperative total analgesic need was recorded as "milligram" in unit.
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 posted15 May 2025
- Study start30 Jan 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oguz Gundogdu, Cumhuriyet University
- Investigators
- Oğuz Gündoğdu, Principal investigator, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973447
- Sponsor's protocol ID
- 2024-01/08
- Status last verified
- Dec 2025
- First submitted
- 7 May 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Combined Anterior Suprascapular Nerve Block and Infraclavicular Brachial Plexus Block Versus Costoclavicular Brachial Plexus Block on Postoperative Pain and Hemidiaphragmatic Paralysis in Shoulder Arthroscopy
- ClinicalTrials.gov ID
- NCT06973447
- Acronym / sponsor ID
- 2024-01/08
- Conditions
- Postoperative Pain, Shoulder Arthroscopy
- Keywords
- postoperative pain, shoulder arthroscopy, regional anesthesia, costoclavicular brachial plexus block, infraclavicular brachial plexus block, anterior suprascapular nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 15 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.
The aim is to compare the postoperative analgesic and hemidiaphragmatic effects of Anterior SupraScapular Nerve Block (ASSNB) and InfraClavicular Brachial Plexus Block (ICBPB) combination versus CostoClavicular Brachial Plexus Block (CCBPB) in patients undergoing shoulder arthroscopic surgery.
Detailed description
Patients were divided into two randomized groups: Group 1 (ASSNB+ICBPB Combination group, n=15) and Group 2 (CCBPB group, n=15). All patients will receive the same standard general anesthesia per hospital protocol. All blocks will be applied with the same ultrasonography and block equipment, and by the same physician. Before the anesthesia induction, ipsilateral diaphragmatic excursion will be measured via Ultrasonography (USG). After the anesthesia induction, patients in Group 1 will receive anterior suprascapular nerve block (ASSNB) with 10 mL of 0.25% bupivacaine and infraclavicular brachial plexus block (ICBPB) with 15 mL of 0.25% bupivacaine (with a total volume of 25 mL). Patients in Group 2 will receive costoclavicular brachial plexus block (CCBPB) with 15 mL of 0.25% bupivacaine. All patients will receive Paracetamol 1gr and Dexketoprofen 50mg intravenous (IV) 10 minutes prior to skin closure. After 30 minutes of emergence from anesthesia (upon reaching 9 points on modified Aldrete scoring), ipsilateral diaphragmatic excursion will be assessed again. Pre- and postblock excursion differences will be recorded. Routine analgesic procedure consisting of 3x1gr Paracetamol and 2x50mg Dexketoprofen will be followed postoperatively for 24 hours. Numeric Rating Scale (NRS) will be used to assess postoperative pain on 1st, 6th, 12th, 18th and 24th hours after the surgery. Quality of Recovery-15 Patient Survey will be done both preoperatively for a baseline score, and postoperatively at 24th hour to assess the quality of recovery from the patients' view. Tramadol 50mg IV will be administered as a rescue analgesic for all patients if NRS score is equal to or higher than 4. Total Tramadol consumption will be calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined ASSNB and ICBPB | Active comparator | Procedure: Anterior suprascapular nerve block (ASSNB), Procedure: Infraclavicular Brachial Plexus Block (ICBPB)For this group, ASSNB and ICBPB blocks will be performed on the ipsilateral side of the patient right after the anesthesia induction with the patients in supine position. For ICBPB, a high frequency linear transducer USG is placed over the lateral infraclavicular fossa in a sagittal orientation medial to the coracoid process and caudal to the clavicle. The block needle is inserted in-plane from a cephalad-to-caudal direction, just inferior to the clavicle to pass through the pectoralis major and minor muscles, aiming toward the posterior aspect of the axillary artery. 15 mL of 0.25% bupivacaine is administered. For ASSNB, the transducer is positioned in a sagittal oblique orientation over the supraclavicular fossa to image the subclavian artery and the brachial plexus. While tracing the plexus craniocaudally, the suprascapular nerve is identified. The needle is advanced in-plane from posterior to anterior. 10 mL of 0.25% bupivacaine is administered. |
| CCBPB | Active comparator | Procedure: Costoclavicular brachial plexus block (CCBPB)For this group, CCBPC will be performed on the ipsilateral side of the patient right after the anesthesia induction with the patients in supine position. For CCBPB, a high frequency linear transducer of the USG is placed in the medial infraclavicular fossa parallel and next to the clavicle to identify the axillary artery. The transducer is then tilted cephalad to image the brachial plexus and the artery in a perpendicular orientation between the subclavius muscle and the serratus anterior. The needle is advanced in-plane in a lateral-to-medial direction, adjusting the angle to reach the space in between the three cords. 15 mL of 0.25% bupivacaine is administered. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients older than 18 years of age who underwent arthroscopic shoulder surgery under general anesthesia and were American Society of Anesthesiologists (ASA) I-II-III according to the ASA risk classification.
Key exclusion criteria (7 listed)
- patients who did not give consent,
- patients with coagulopathy,
- patients with signs of infection at the block application site,
- patients using anticoagulants,
- patients with local anesthetic drug allergies,
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 |
|---|---|---|
| Anterior suprascapular nerve block (ASSNB)10 mL of 0.25% bupivacaine | Procedure or surgery | Combined ASSNB and ICBPB |
| Infraclavicular Brachial Plexus Block (ICBPB)15 mL of 0.25% bupivacaine | Procedure or surgery | Combined ASSNB and ICBPB |
| Costoclavicular brachial plexus block (CCBPB)15 mL of 0.25% bupivacaine | Procedure or surgery | CCBPB |
Primary outcome
Numeric Rating Scale (NRS) Scores
Time frame: Postoperative 24 hours
Numerical rating scale is used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.
Diaphragmatic Excursion Difference
Time frame: Preoperatively right before the anesthesia induction, and postoperatively after 30 minutes of emergence from anesthesia (upon reaching 9 points on modified Aldrete scoring)
Ipsilateral diaphragmatic excursions will be measured both preoperatively right before the anesthesia induction, and postoperatively after 30 minutes of emergence from anesthesia (upon reaching 9 points on modified Aldrete scoring). A diaphragmatic excursion change of up to 25% indicates no nerve involvement, a change between 25%-75% indicates partial involvement, and a change exceeding 75% indicates complete involvement of the phrenic nerve.
2 secondary outcomes
Quality of Recovery-15 Patient Survey (QoR-15)
Time frame: Preoperatively and Postoperatively at 24th hour
Total tramadol consumption
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 29 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Oğuz Gündoğdu principal investigator
Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior suprascapular nerve block (ASSNB), Infraclavicular Brachial Plexus Block (ICBPB) and Costoclavicular brachial plexus block (CCBPB) in people with Postoperative Pain and Shoulder Arthroscopy, run by Cumhuriyet 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 1 inclusion and 7 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 29 Dec 2025. 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?
Numeric Rating Scale (NRS) Scores (time frame: Postoperative 24 hours). The study lists 2 primary outcomes in all. 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 29 Dec 2025.