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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05683522
Other study ID # SamsunO
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 13, 2023
Est. completion date May 24, 2024

Study information

Verified date May 2024
Source Samsun University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date May 24, 2024
Est. primary completion date May 24, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Sub-omohyoidal 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.
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 Block
Costoclavicular brachial plexus block will be applied by administering 20 mL of local anesthetic under ultrasound guidance. This block will be performed preoperatively.

Locations

Country Name City State
Turkey Samsun University Samsun

Sponsors (1)

Lead Sponsor Collaborator
Samsun University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 24 hours opioid consumption morphine consumptions for both group will be recorded up to 24 hours
Secondary Numeric rating scale for postoperative pain intensity 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
Secondary Quality of Recovery (QoR) 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
Secondary Incidence of hemidiaphragm paralysis at 30 minutes after sub-omohyoid plan or costoclavicular plus cervical plexus block Ultrasound diagnosed hemidiaphragm paralysis 30 minutes post injection
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