- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07553611
The Effects of Regional Anaesthesia Techniques on Hemidiaphragm Paralysis, Postoperative Recovery Quality, Opioid Consumption, and Pain Scores
May 6, 2026 updated by: Antalya Training and Research Hospital
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
88
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Arzu Karaveli
- Phone Number: +905325611300
- Email: arzukaraveli@hotmail.com
Study Contact Backup
- Name: Bayram Akdag
- Phone Number: +905427688949
- Email: bayramakdag6507@gmail.com
Study Locations
-
-
Muratpaşa
-
Antalya, Muratpaşa, Turkey (Türkiye)
- Recruiting
- University of Health Sciences, Antalya Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
It is planned to include ASA score I-III, aged 18-65 years, who are planned to undergo elective arthroscopic surgery
Description
Inclusion Criteria:
- aged 18-65 years
- American Society of Anaesthesiology (ASA) score I-III
- body mass index (BMI) <30kg/m2
- scheduled for elective arthroscopic surgery
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
İnterscalene group
Before the surgery, ultrasoud-guided interscalene block will be performed
|
Before the surgery, ultrasoud-guided interscalene block will be performed before the surgery under standart anaesthesia monitoring
|
|
Erector spinae plane block group
Before the surgery, ultrasoud-guided erector spinae plane block will be performed
|
Before the surgery, ultrasoud-guided erector spinae plane block will be performed before the surgery under standart anaesthesia monitoring
|
|
Costoclavicular block group
Before the surgery, ultrasoud-guided costoclavicular block will be performed
|
Before the surgery, ultrasoud-guided costoclavicular block will be performed before the surgery under standart anaesthesia monitoring
|
|
Supraclavicular block group
Before the surgery, ultrasoud-guided supraclavicular block will be performed
|
Before the surgery, ultrasoud-guided supraclavivular block will be performed before the surgery under standart anaesthesia monitoring
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recovery quality
Time Frame: 5 minutes
|
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.
|
5 minutes
|
|
Postoperative analgesic consumption
Time Frame: 24 hours
|
All patients will receive a standard patient analgesia (PCA) protocol.
The postoperative opioid consumption will only be recorded
|
24 hours
|
|
Postoperative pain intensity
Time Frame: 24 hours
|
The postoperative pain intensity will be assessed with the Numerical Rating Scale (NRS) score (0=no pain; 10=most severe pain)
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Arzu Karaveli, University of Health Sciences, Antalya Training and Research Hospital
- Principal Investigator: Bayram Akdag, University of Health Sciences, Antalya Training and Research Hospital
- Principal Investigator: Fatih Duygun, University of Health Sciences, Antalya Training and Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kim 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 21, 2026
Primary Completion (Estimated)
October 21, 2026
Study Completion (Estimated)
November 21, 2026
Study Registration Dates
First Submitted
April 21, 2026
First Submitted That Met QC Criteria
April 21, 2026
First Posted (Actual)
April 28, 2026
Study Record Updates
Last Update Posted (Actual)
May 11, 2026
Last Update Submitted That Met QC Criteria
May 6, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 4/21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.