- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07445126
Comparison of the Effectiveness of USG-Guided Interscalene Block Versus Combined Interscalen-Suprascapular Block for Arthroscopic Shoulder Surgery (ISB vs SSB)
Comparison of the Effectiveness of Ultrasound-Guided Interscalene Block Versus Combined Interscalene and Suprascapular Nerve Blocks in Arthroscopic Shoulder Surgery
Study Overview
Status
Conditions
Detailed Description
Arthroscopic shoulder surgery is a commonly performed procedure, and effective perioperative analgesia is essential for improving patient comfort, reducing opioid consumption, and enabling early rehabilitation. The ultrasound-guided interscalene block is considered the standard regional anesthesia technique for shoulder surgery; however, it may cause hemidiaphragmatic paresis due to phrenic nerve involvement. To reduce this risk while maintaining effective analgesia, the combination of interscalene and suprascapular nerve blocks has recently gained attention as a promising alternative.
The suprascapular nerve supplies approximately 70% of sensory innervation to the shoulder joint, and its blockade may enhance postoperative pain control when combined with a low-volume interscalene block. This combined technique has been proposed as a potentially safer option with fewer respiratory side effects, particularly in patients at risk of reduced pulmonary reserve.
This prospective, randomized clinical study aims to compare the analgesic efficacy and respiratory effects of the ultrasound-guided interscalene block versus the combined interscalene-suprascapular nerve block in patients undergoing arthroscopic shoulder surgery. Participants will be assigned to one of the two block techniques prior to surgery. Standardized anesthesia and postoperative care protocols will be applied. Primary outcomes include postoperative pain scores and opioid consumption during the first 24 hours. Secondary outcomes include diaphragm excursion measurements, block-related complications, patient satisfaction, and recovery profiles.
The results of this study are expected to contribute to determining whether the combined technique provides comparable or superior analgesia with fewer respiratory side effects, potentially offering a safer alternative to traditional interscalene block for shoulder surgery.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Asuman ocaklar, MD, Anesthesiologist
- Phone Number: +90 5442013991
- Email: asuman-kcygt@hotmail.com
Study Contact Backup
- Name: asuman Ocaklar, MD, Anesthesiologist
- Phone Number: +90 5375909724
- Email: canocaklar@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Planned arthroscopic shoulder surgery ASA physical status I-III Age between 18 and 75 years Ability to provide informed consent Suitable for regional anesthesia with ultrasound guidance
Exclusion Criteria:
Allergy or contraindication to local anesthetics Coagulopathy or current anticoagulant therapy Infection at the block injection site Severe pulmonary disease (e.g., severe COPD) Pre-existing neurological deficit in the operative upper limb Body mass index > 40 kg/m² Pregnancy or breastfeeding History of phrenic nerve palsy Inability to cooperate with block procedure or follow-up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Interscalene Block (ISB)
Participants in this arm will receive an ultrasound-guided interscalene brachial plexus block.
The block will be performed at the level of the C5-C6 nerve roots using a high-frequency linear ultrasound probe.
A local anesthetic solution will be injected around the brachial plexus under real-time ultrasound visualization.
This intervention represents the standard regional anesthesia technique used for arthroscopic shoulder surgery.
|
An ultrasound-guided interscalene brachial plexus block performed at the C5-C6 level using a high-frequency linear ultrasound probe.
Local anesthetic is injected around the brachial plexus under real-time ultrasound visualization.
This technique represents the standard regional anesthesia method for arthroscopic shoulder surgery.
|
|
Experimental: ISB+ Suprascapular Block ( ISB+ SSNB)
Participants in this arm will receive a combined regional anesthesia technique consisting of an ultrasound-guided interscalene block followed by an ultrasound-guided suprascapular nerve block.
The interscalene block will be performed at the C5-C6 level using a high-frequency linear probe.
The suprascapular nerve block will be administered at the suprascapular notch under ultrasound visualization.
Local anesthetic will be injected around both the brachial plexus and the suprascapular nerve.
This combined technique is intended to enhance postoperative analgesia while potentially reducing phrenic nerve involvement compared with the interscalene block alone
|
A combined regional anesthesia technique consisting of an ultrasound-guided interscalene block performed at the C5-C6 level, followed by an ultrasound-guided suprascapular nerve block administered at the suprascapular notch.
Local anesthetic is injected around both the brachial plexus and the suprascapular nerve under ultrasound guidance.
This technique aims to improve postoperative analgesia while potentially reducing phrenic nerve involvement.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Score (VAS 0-24 Hours)
Time Frame: 0-24 hours after surgery
|
Postoperative pain intensity will be assessed using a standard 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Pain scores will be recorded at predefined postoperative time points (e.g., 1, 2, 6, 12, and 24 hours).
The primary outcome will be the comparison of cumulative VAS scores between the interscalene block group and the combined interscalene-suprascapular block group during the first 24 postoperative hours.
|
0-24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Postoperative Opioid Consumption (0-24 Hours)
Time Frame: 0-24 hours after surgery
|
Total postoperative opioid consumption will be recorded during the first 24 hours after surgery.
All opioid medications will be converted to intravenous morphine milligram equivalents (MME) for standardized comparison between groups.
The cumulative opioid requirement of the interscalene block group will be compared with that of the combined interscalene-suprascapular block group.
|
0-24 hours after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRÜ/26.01.72
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Postoperative Pain
-
National and Kapodistrian University of AthensCompletedPostoperative Pain, Acute | Postoperative Pain, Chronic | Postoperative Pain After Thoracic SurgeryGreece
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingPostoperative Pain | Postoperative Pain Management | Postoperative Pain in Orthopaedics
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Children's National Research InstituteVentureWellRecruitingPostoperative Pain | Acute Pain | Acute Pain, PostoperativeUnited States
-
University of MalayaActive, not recruitingPostoperative Pain | Postoperative Pain ManagementMalaysia
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
Clinical Trials on Ultrasound-Guided Interscalene Block
-
Cheju Halla General HospitalCompletedPainKorea, Republic of
-
Hospital del Trabajador de SantiagoRecruitingShoulder Surgery | Brachial Plexus Blockade | Superficial Cervical Plexus BlockChile
-
Ordu UniversityRecruitingCardiovascular Diseases | Pain, Postoperative | Cardiovascular Surgical ProceduresTurkey (Türkiye)
-
Medipol UniversityProf. Dr. Cemil Tascıoglu Education and Research Hospital Organization; Biruni...RecruitingPostoperative Pain | CryptorchidismTurkey (Türkiye)
-
Alexandria UniversityCompletedPain Management | PCNL | Postoperative Analgesia | Regional Anesthesia BlockEgypt
-
Misr University for Science and TechnologyActive, not recruitingPain | Pain Management | Pain Management in Postoperative CareEgypt
-
Bangladesh Medical UniversityCompletedPostoperative Pain | Hypospadias | Pudendal Nerve Block | Penile Nerve BlockBangladesh
-
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training...RecruitingPostoperative Pain | Hip Fracture | Regional AnesthesiaTurkey (Türkiye)
-
Karabuk UniversityCompletedPain Management | Erector Spina Plan Block | External Oblique Intercostal BlockTurkey (Türkiye)
-
University Hospital, CaenNot yet recruitingPostoperative Care | Postoperative Analgesia | Analgesia Assessment | PosthectomyFrance