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Subomohyoid vs Costoclavicular Block in Shoulder Surgery

Primary Purpose

Shoulder Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Sub-omohyoidal Plane Block
Cervical Plexus Block
Costoclavicular Block
Sponsored by
Samsun University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Arthroscopic shoulder surgery, Postoperative pain management, Subomohyoid Plane Block, Superficial Cervical Plexus Block, Costaclavicular Block

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsun UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sub-omohyoidal Plane Block

Costoclavicular Block plus Cervical Plexus Block

Arm Description

Patients randomized to receive sub-omohyoid plane block.

Patients randomized to receive costoclavicular brachial and cervical plexus block.

Outcomes

Primary Outcome Measures

24 hours opioid consumption
morphine consumptions for both group will be recorded

Secondary Outcome Measures

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
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.
Incidence of hemidiaphragm paralysis at 30 minutes after sub-omohyoid plan or costoclavicular plus cervical plexus block
Ultrasound diagnosed hemidiaphragm paralysis

Full Information

First Posted
January 4, 2023
Last Updated
January 13, 2023
Sponsor
Samsun University
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1. Study Identification

Unique Protocol Identification Number
NCT05683522
Brief Title
Subomohyoid vs Costoclavicular Block in Shoulder Surgery
Official Title
Comparison of Postoperative Analgesic Efficacy of Combination of Costaclavicular With Superficial Cervical Plexus Block Versus Subomohyoid Plane Block in Patients Undergoing Arthroscopic Shoulder Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2023 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
August 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsun University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Arthroscopic shoulder surgery, Postoperative pain management, Subomohyoid Plane Block, Superficial Cervical Plexus Block, Costaclavicular Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
There are two models for this study. The first group is subomohyoid plane block group. The second one is combination of costaclavicular with superficial cervical plexus block.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The patient and the anesthesiologist who performs postoperative pain evaluation will not know the group.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sub-omohyoidal Plane Block
Arm Type
Experimental
Arm Description
Patients randomized to receive sub-omohyoid plane block.
Arm Title
Costoclavicular Block plus Cervical Plexus Block
Arm Type
Experimental
Arm Description
Patients randomized to receive costoclavicular brachial and cervical plexus block.
Intervention Type
Other
Intervention Name(s)
Sub-omohyoidal Plane Block
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cervical Plexus Block
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Costoclavicular Block
Intervention Description
Costoclavicular brachial plexus block will be applied by administering 20 mL of local anesthetic under ultrasound guidance. This block will be performed preoperatively.
Primary Outcome Measure Information:
Title
24 hours opioid consumption
Description
morphine consumptions for both group will be recorded
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
Numeric rating scale for postoperative pain intensity
Description
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
Time Frame
up to 24 hours
Title
Quality of Recovery (QoR)
Description
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.
Time Frame
Postoperative 24th hour
Title
Incidence of hemidiaphragm paralysis at 30 minutes after sub-omohyoid plan or costoclavicular plus cervical plexus block
Description
Ultrasound diagnosed hemidiaphragm paralysis
Time Frame
30 minutes post injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Serkan Tulgar
Phone
+905055423985
Email
serkantulgar.md@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Serkan Tulgar
Organizational Affiliation
Samsun University Faculty of Medicine, Samsun Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsun University
City
Samsun
ZIP/Postal Code
55090
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serkan Tulgar
Phone
05055423985
Email
serkantulgar.md@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23086351
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.
Results Reference
background
PubMed Identifier
27956687
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.
Results Reference
background
PubMed Identifier
30635497
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.
Results Reference
background
PubMed Identifier
32044802
Citation
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.
Results Reference
background
PubMed Identifier
25899958
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.
Results Reference
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Subomohyoid vs Costoclavicular Block in Shoulder Surgery

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