Regional AnaesthesiaNCT07553611
The Effects of Regional Anaesthesia Techniques on Hemidiaphragm Paralysis, Postoperative Recovery Quality, Opioid Consumption, and Pain Scores
An observational study of Regional Anaesthesia and Arthroscopic Shoulder Surgery, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effects of ultrasound-guided interscalene, erector spinae plane, costoclavicular, and supraclavicular blocks on hemidiaphragmatic paralysis, postoperative recovery quality, opioid consumption, and pain scores. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Regional Anaesthesia, Arthroscopic Shoulder Surgery, Hemidiaphragmatic Paralysis
- What is being tested?
- İnterscalene block group, Erector spinae plane block group and Costoclavicular block group
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Apr 2026to 21 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: It is planned to include ASA score I-III, aged 18-65 years, who are planned to undergo elective arthroscopic surgery
Who may be able to join
- aged 18-65 years
- American Society of Anaesthesiology (ASA) score I-III
- body mass index (BMI) <30kg/m2
- scheduled for elective arthroscopic surgery
Who cannot join
- ASA score ≥4
- BMI ≥30 kg/m2
- declining to give written informed consent
- controendications for block application
- history of mental or neurological disease, severe liver and/or kidney disease
- history of moderate or severe pulmonary disease
- abnormal preoperative chest X-ray findings
- scheduled for emergency surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Health Sciences, Antalya Training and Research Hospital
Antalya, Muratpaşa
About this study
Official title: Comparion of the Effects of Ultrasound-guided Interscalene Block, Erector Spinae Plane Block, Costoclavicular Block, and Supraclavicular Block on Hemidiaphragm Paralysis, Postoperative Recovery Quality, Opioid Consumption, and Pain Scores in Patients Undergoing Arthroscopic Shoulder Surgery: a Prospective Observational Trial
This study aims to evaluate the effects of ultrasound-guided interscalene, erector spinae plane, costoclavicular, and supraclavicular blocks on hemidiaphragmatic paralysis, postoperative recovery quality, opioid consumption, and pain scores.
Read the detailed description
Arthroscopic shoulder surgery is a significant approach to diagnosing and treating rotator cuff tears, impingement syndrome, instability, SLAP and Bankart injuries, and other shoulder disorders. Applications of this technique have become increasingly popular in recent yeras. Howeveri although arthroscopic sholuder surgery is conderered minimally invasive, it has been reported to cause moderate to severe postoperative pain, which can hinder patient recovery and rehabilitation, and potentially even extend the hospital stay. Therefore, providing an effective postoperative analgesia strategy in these patients is critical for patient comfort, mobilization, and overall recovery. Various methods are employed to managepostoperative pain in patients undergoing arthroscopic shoulder surgery, with regional techniques being the most prevalent. These regional techniques provide both intraoperative and postoperative analgesia in shoulder surgeries. The aim of this study is to evaluate the effects of ultrasound-guided four block techniques on hemidiaphragmatic paralysis, postoperative recovery quality, opioid consumption, and pain scores.
- Conditions
- Regional Anaesthesia, Arthroscopic Shoulder Surgery, Hemidiaphragmatic Paralysis, Recovery Quality, Opioid Consumption, Postoperative Pain Score
- Being tested
- İnterscalene block group, Erector spinae plane block group, Costoclavicular block group, Supraclavivular block group
- Keywords
- regional anaesthesia, arthroscopic shoulder surgery, hemidiaphragmatic paralysis, recovery quality, opioid consumption, postoperative pain score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
İnterscalene block groupOther
Before the surgery, ultrasoud-guided interscalene block will be performed before the surgery under standart anaesthesia monitoring
Erector spinae plane block groupOther
Before the surgery, ultrasoud-guided erector spinae plane block will be performed before the surgery under standart anaesthesia monitoring
Costoclavicular block groupOther
Before the surgery, ultrasoud-guided costoclavicular block will be performed before the surgery under standart anaesthesia monitoring
Supraclavivular block groupOther
Before the surgery, ultrasoud-guided supraclavivular block will be performed before the surgery under standart anaesthesia monitoring
| Study group | Role | What they receive |
|---|---|---|
| İnterscalene group | Before the surgery, ultrasoud-guided interscalene block will be performed Receives: Other: İnterscalene block group | |
| Erector spinae plane block group | Before the surgery, ultrasoud-guided erector spinae plane block will be performed Receives: Other: Erector spinae plane block group | |
| Costoclavicular block group | Before the surgery, ultrasoud-guided costoclavicular block will be performed Receives: Other: Costoclavicular block group | |
| Supraclavicular block group | Before the surgery, ultrasoud-guided supraclavicular block will be performed Receives: Other: Supraclavivular block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemidiaphragmatic paralysis
Diaghragmatic excursion will be assessed using a real-time M-mode ultrasound during quite breathing, deep breathing, and sniffing maneuvers (deep breathing through the nose)
Measured: 30 minutes
Secondary outcomes (3)
Recovery quality
The postoperative recovery of patients will be assessed using the 15-item Quality of Recovery (QOR-15) score. The QOR-15 is an 15-item assessment scale that evaluates patients' pain, physical comfort, physical independence, psychological support and emotional state in early postoperative period.
Measured: 5 minutes
Postoperative analgesic consumption
All patients will receive a standard patient analgesia (PCA) protocol. The postoperative opioid consumption will only be recorded
Measured: 24 hours
Postoperative pain intensity
The postoperative pain intensity will be assessed with the Numerical Rating Scale (NRS) score (0=no pain; 10=most severe pain)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start21 Apr 2026
- Primary completion21 Oct 2026 (estimated)
- Study completion21 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Regional AnaesthesiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Arzu Karaveli, Principal investigator, University of Health Sciences, Antalya Training and Research HospitalBayram Akdag, Principal investigator, University of Health Sciences, Antalya Training and Research HospitalFatih Duygun, Principal investigator, University of Health Sciences, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553611
- Sponsor's protocol ID
- 4/21
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shagufta N, Nishant S, Rajnish K, Adil A. Hemidiaphragmatic paralysis following costoclavicular versus supraclavicular brachial plexus block: A systematic review and meta-analysis. J Anaesthesiol Clin Pharmacol. 2025 Oct-Dec;41(4):587-599. doi: 10.4103/joacp.joacp_415_24. Epub 2025 Jul 9.
PubMed 41181256Kim DH, Lin Y, Beathe JC, Liu J, Oxendine JA, Haskins SC, Ho MC, Wetmore DS, Allen AA, Wilson L, Garnett C, Memtsoudis SG. Superior Trunk Block: A Phrenic-sparing Alternative to the Interscalene Block: A Randomized Controlled Trial. Anesthesiology. 2019 Sep;131(3):521-533. doi: 10.1097/ALN.0000000000002841.
PubMed 31283740
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparion of the Effects of Ultrasound-guided Interscalene Block, Erector Spinae Plane Block, Costoclavicular Block, and Supraclavicular Block on Hemidiaphragm Paralysis, Postoperative Recovery Quality, Opioid Consumption, and Pain Scores in Patients Undergoing Arthroscopic Shoulder Surgery: a Prospective Observational Trial
- ClinicalTrials.gov ID
- NCT07553611
- Acronym / sponsor ID
- 4/21
- Conditions
- Regional Anaesthesia, Arthroscopic Shoulder Surgery, Hemidiaphragmatic Paralysis, Recovery Quality, Opioid Consumption, Postoperative Pain Score
- Keywords
- regional anaesthesia, arthroscopic shoulder surgery, hemidiaphragmatic paralysis, recovery quality, opioid consumption, postoperative pain score
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 21 Oct 2026 (estimated)
- Study completion
- 21 Nov 2026 (estimated)
- First posted
- 28 Apr 2026 (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.
This study aims to evaluate the effects of ultrasound-guided interscalene, erector spinae plane, costoclavicular, and supraclavicular blocks on hemidiaphragmatic paralysis, postoperative recovery quality, opioid consumption, and pain scores.
Detailed description
Arthroscopic shoulder surgery is a significant approach to diagnosing and treating rotator cuff tears, impingement syndrome, instability, SLAP and Bankart injuries, and other shoulder disorders. Applications of this technique have become increasingly popular in recent yeras. Howeveri although arthroscopic sholuder surgery is conderered minimally invasive, it has been reported to cause moderate to severe postoperative pain, which can hinder patient recovery and rehabilitation, and potentially even extend the hospital stay. Therefore, providing an effective postoperative analgesia strategy in these patients is critical for patient comfort, mobilization, and overall recovery. Various methods are employed to managepostoperative pain in patients undergoing arthroscopic shoulder surgery, with regional techniques being the most prevalent. These regional techniques provide both intraoperative and postoperative analgesia in shoulder surgeries. The aim of this study is to evaluate the effects of ultrasound-guided four block techniques on hemidiaphragmatic paralysis, postoperative recovery quality, opioid consumption, and pain scores.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| İnterscalene group | – | Other: İnterscalene block groupBefore the surgery, ultrasoud-guided interscalene block will be performed |
| Erector spinae plane block group | – | Other: Erector spinae plane block groupBefore the surgery, ultrasoud-guided erector spinae plane block will be performed |
| Costoclavicular block group | – | Other: Costoclavicular block groupBefore the surgery, ultrasoud-guided costoclavicular block will be performed |
| Supraclavicular block group | – | Other: Supraclavivular block groupBefore the surgery, ultrasoud-guided supraclavicular block will be performed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It is planned to include ASA score I-III, aged 18-65 years, who are planned to undergo elective arthroscopic surgery
Key inclusion criteria (4 listed)
- aged 18-65 years
- American Society of Anaesthesiology (ASA) score I-III
- body mass index (BMI) <30kg/m2
- scheduled for elective arthroscopic surgery
Key exclusion criteria (8 listed)
- ASA score ≥4
- BMI ≥30 kg/m2
- declining to give written informed consent
- controendications for block application
- history of mental or neurological disease, severe liver and/or kidney disease
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 |
|---|---|---|
| İnterscalene block groupBefore the surgery, ultrasoud-guided interscalene block will be performed before the surgery under standart anaesthesia monitoring | Other | İnterscalene group |
| Erector spinae plane block groupBefore the surgery, ultrasoud-guided erector spinae plane block will be performed before the surgery under standart anaesthesia monitoring | Other | Erector spinae plane block group |
| Costoclavicular block groupBefore the surgery, ultrasoud-guided costoclavicular block will be performed before the surgery under standart anaesthesia monitoring | Other | Costoclavicular block group |
| Supraclavivular block groupBefore the surgery, ultrasoud-guided supraclavivular block will be performed before the surgery under standart anaesthesia monitoring | Other | Supraclavicular block group |
Primary outcome
Hemidiaphragmatic paralysis
Time frame: 30 minutes
Diaghragmatic excursion will be assessed using a real-time M-mode ultrasound during quite breathing, deep breathing, and sniffing maneuvers (deep breathing through the nose)
3 secondary outcomes
Recovery quality
Time frame: 5 minutes
Postoperative analgesic consumption
Time frame: 24 hours
Postoperative pain intensity
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 41181256Shagufta N, Nishant S, Rajnish K, Adil A. Hemidiaphragmatic paralysis following costoclavicular versus supraclavicular brachial plexus block: A systematic review and meta-analysis. J Anaesthesiol Clin Pharmacol. 2025 Oct-Dec;41(4):587-599. doi: 10.4103/joacp.joacp_415_24. Epub 2025 Jul 9.
- Background: PubMed 31283740Kim DH, Lin Y, Beathe JC, Liu J, Oxendine JA, Haskins SC, Ho MC, Wetmore DS, Allen AA, Wilson L, Garnett C, Memtsoudis SG. Superior Trunk Block: A Phrenic-sparing Alternative to the Interscalene Block: A Randomized Controlled Trial. Anesthesiology. 2019 Sep;131(3):521-533. doi: 10.1097/ALN.0000000000002841.
- Individual participant dataSharing planned: No
Related trials for Regional Anaesthesia
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Not yet recruiting
Use of a Virtual Reality Headset During Prostate Biopsy Under Local Anesthesia to Improve the Patient's Experience
Prostate Biopsy
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
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.
Arzu Karaveli principal investigator
University of Health Sciences, Antalya Training and Research Hospital
Bayram Akdag principal investigator
University of Health Sciences, Antalya Training and Research Hospital
Fatih Duygun principal investigator
University of Health Sciences, Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Anaesthesia and Arthroscopic Shoulder Surgery, run by Antalya Training and Research 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 8 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: looking for participants now, as of the sponsor's last update on 11 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Arzu Karaveli (+905325611300, arzukaraveli@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemidiaphragmatic paralysis (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07553611, which also lists 2 linked publications.
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 11 May 2026.