- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05683522
Subomohyoid vs Costoclavicular Block in Shoulder Surgery
Comparison of Postoperative Analgesic Efficacy of Combination of Costaclavicular With Superficial Cervical Plexus Block Versus Subomohyoid Plane Block in Patients Undergoing Arthroscopic Shoulder Surgery
Postoperative pain is important following arthroscopic shoulder surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay.Ultrasound (US)-guided brachial plexus blocks such as interscalen and supraclavicular block are usually performed. Interscalen brachial plexus block is one of the most preferred techniques among these.
Anterior suprascapular nerve block (subomohyoid plane block), which provides superior trunk block, as described by Siegenthaler et al., has been used for analgesia in shoulder arthroscopies because it is far from the neck and phrenic nerve.
Karmakar et al. described the costoclavicular nerve block, which provides blocking of the posterior, medial and lateral cords of the brachial plexus. It has been suggested as an alternative to postoperative analgesia in shoulder arthroscopies and compared with interscalene brachial plexus block.
The aim of this study is to compare the post op analgesic efficacy of both nerve blocks in shoulder arthroscopic surgeries.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Postoperative pain is an important issue in patients underwent arthroscopic shoulder surgery. Pain causes a few problems; discomfortable patients, negative outcomes and longer rehabilitation. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization such as infection and thromboembolism may be reduced. Various techniques may be used for postoperative pain treatment. Opioids are one of the most preferred drugs among the analgesic agents. Parenteral opioids are generally performed for patients after surgery. However opioids have undesirable adverse events such as nausea, vomiting, itching, sedation and respiratory depression (opioid-related adverse events).
Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following arthroscopic shoulder surgery. Ultrasound (US)-guided brachial plexus blocks such as interscalen and supraclavicular block are commonly used. Interscalen brachial plexus block is one of the most preferred techniques among these.
Ultrasound-guided nerve blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice. US-guided subomohyoid and costoclavicular block are techniques that target the brachial plexus, and their use has increased in recent years. Patients will undergo preoperative subomohyoid block as described by Siegenthaler et al. In the other patient group, costoclavicular block will be applied as described by Karmakar et al. Superficial cervical brachial plexus block will also be applied to this group.
There is no study in the literature about the effectiveness of these techniques against each other. The aim of this study was to evaluate the postoperative analgesic efficacy of the subomohyoid plane block and combination of costoclavicular and superficial cervical plexus block after arthroscopic shoulder surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Samsun, Turkey, 55090
- Samsun University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) classification I-II-III
- Scheduled for arthroscopic shoulder surgery under general anesthesia
Exclusion Criteria:
- history of bleeding diathesis,
- receiving anticoagulant treatment,
- known local anesthetics and opioid allergy,
- infection of the skin at the site of the needle puncture,
- pregnancy or lactation,
- patients who do not accept the procedure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sub-omohyoidal Plane Block
Patients randomized to receive sub-omohyoid plane block.
|
The ultrasound guided sub-omohyoidal plane block will be performed.
Patients in this group will be given 15 mL of local anesthetic into the interfascial plane under the omohyoid muscle.
This block will be performed preoperatively.
|
|
Experimental: Costoclavicular Block plus Cervical Plexus Block
Patients randomized to receive costoclavicular brachial and cervical plexus block.
|
A cervical plexus block will be applied by applying 10 mL of local anesthetic under ultrasound guidance.
This block will be done before the surgery.
Costoclavicular brachial plexus block will be applied by administering 20 mL of local anesthetic under ultrasound guidance.
This block will be performed preoperatively.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
24 hours opioid consumption
Time Frame: up to 24 hours
|
morphine consumptions for both group will be recorded
|
up to 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric rating scale for postoperative pain intensity
Time Frame: up to 24 hours
|
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals.
NRS is a unidimensional measure of pain intensity in adults.
The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects
|
up to 24 hours
|
|
Quality of Recovery (QoR)
Time Frame: Postoperative 24th hour
|
The impact of surgical and anesthetic interventions on perioperative quality of life and ability to resume routine life activities will be assessed using the Quality of Recovery (QoR) tool.
The QoR-15 scale is a patient-based outcome measure in the form of a 15-item validated questionnaire.
|
Postoperative 24th hour
|
|
Incidence of hemidiaphragm paralysis at 30 minutes after sub-omohyoid plan or costoclavicular plus cervical plexus block
Time Frame: 30 minutes post injection
|
Ultrasound diagnosed hemidiaphragm paralysis
|
30 minutes post injection
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Serkan Tulgar, Samsun University Faculty of Medicine, Samsun Training and Research Hospital
Publications and helpful links
General Publications
- Karmakar MK, Sala-Blanch X, Songthamwat B, Tsui BC. Benefits of the costoclavicular space for ultrasound-guided infraclavicular brachial plexus block: description of a costoclavicular approach. Reg Anesth Pain Med. 2015 May-Jun;40(3):287-8. doi: 10.1097/AAP.0000000000000232. No abstract available.
- Aliste J, Bravo D, Layera S, Fernandez D, Jara A, Maccioni C, Infante C, Finlayson RJ, Tran DQ. Randomized comparison between interscalene and costoclavicular blocks for arthroscopic shoulder surgery. Reg Anesth Pain Med. 2019 Jan 11:rapm-2018-100055. doi: 10.1136/rapm-2018-100055. Online ahead of print.
- Price D. Novel ultrasound-guided suprascapular nerve block. Reg Anesth Pain Med. 2012 Nov-Dec;37(6):676-7; author reply 677. doi: 10.1097/AAP.0b013e3182680bfe. No abstract available.
- Sondekoppam RV, Lopera-Velasquez LM, Naik L, Ganapathy S. Subscapularis and sub-omohyoid plane blocks: an alternative to peripheral nerve blocks for shoulder analgesia. Br J Anaesth. 2016 Dec;117(6):831-832. doi: 10.1093/bja/aew370. No abstract available.
- Abdallah FW, Wijeysundera DN, Laupacis A, Brull R, Mocon A, Hussain N, Thorpe KE, Chan VWS. Subomohyoid Anterior Suprascapular Block versus Interscalene Block for Arthroscopic Shoulder Surgery: A Multicenter Randomized Trial. Anesthesiology. 2020 Apr;132(4):839-853. doi: 10.1097/ALN.0000000000003132. Erratum In: Anesthesiology. 2020 Apr 3;:null.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- SamsunO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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 Shoulder Pain
-
Nida Koçer NazlıgülCompletedShoulder Impingement Syndrome | Chronic Shoulder Pain | Rotator Cuff-Related Shoulder Pain | Suprascapular Nerve-Related Shoulder PainTurkey (Türkiye)
-
Istanbul University - CerrahpasaRecruitingSubacromial Pain Syndrome | Patient Education | Shoulder Pain Syndrome | Rotator Cuff Related Shoulder PainTurkey (Türkiye)
-
Helping Hand Institute of Rehabilitation SciencesRecruitingShoulder Injuries | Shoulder Capsulitis | Shoulder Arthritis | Shoulder Impingement | Shoulder Bursitis | Shoulder Pain ChronicPakistan
-
Istanbul UniversityRecruitingSubacromial Pain Syndrome | Shoulder Bursitis | Shoulder Tendinopathy | Rotator Cuff Tears of the Shoulder | Rotator Cuff Related Shoulder PainTurkey (Türkiye)
-
University Ramon LlullCompletedHealthy | Shoulder Impingement Syndrome | Shoulder Injury | Shoulder Flexibility | Shoulder Pain Chronic | Shoulder Joint LimitationSpain
-
Deraya UniversityNot yet recruitingAdhesive Capsulitis of Shoulder | Frozen Shoulder | Shoulder Pain and StiffnessEgypt
-
Royal National Orthopaedic Hospital NHS TrustSyncVR MedicalNot yet recruitingShoulder Pain | Chronic Shoulder Pain | Musculoskeletal Shoulder PainUnited Kingdom
-
Universidad de ZaragozaAragon Institute for Health Research (IIS Aragón)CompletedShoulder Pain Syndrome | Nonspecific Shoulder PainSpain
-
Şeyhmus KAPLANCompletedSubacromial Impingement | Pain, Shoulder
-
University of Southern DenmarkRegion of Southern Denmark; The Danish Rheumatism Association; Esbjerg Municipality and other collaboratorsCompletedHypermobility Syndrome Shoulder | Shoulder Pain Chronic | Shoulder LuxationDenmark
Clinical Trials on Sub-omohyoidal Plane Block
-
Zagazig UniversityRecruitingDiscitis of Thoracic RegionEgypt
-
National Cancer Institute, EgyptRecruiting
-
Cairo UniversityRecruitingBreast Cancer PatientsEgypt
-
Tanta UniversityRecruiting
-
Alexandria UniversityNot yet recruiting
-
BEDİA MİNE HANEDANCompletedPostoperative Pain | Cardiac SurgeryTurkey (Türkiye)
-
Cumhuriyet UniversityCompleted
-
Istanbul Medeniyet UniversityNot yet recruitingExternal Oblique Intercostal Plane Block | Subcostal Transverse Abdominis Plane Block
-
Tanta UniversityCompletedAnalgesia | Erector Spinae Plane Block | Thoracoscopic Sympathectomy | Transverse Thoracic Plane Block | Midpoint Transverse Process Plane to Pleura BlockEgypt
-
Bursa City HospitalRecruitingPain, PostoperativeTurkey (Türkiye)