NCT05683522

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 13, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2024

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

1.4 years

First QC Date

January 4, 2023

Last Update Submit

May 24, 2024

Conditions

Keywords

Arthroscopic shoulder surgeryPostoperative pain managementSubomohyoid Plane BlockSuperficial Cervical Plexus BlockCostaclavicular Block

Outcome Measures

Primary Outcomes (1)

  • 24 hours opioid consumption

    morphine consumptions for both group will be recorded

    up to 24 hours

Secondary Outcomes (3)

  • Numeric rating scale for postoperative pain intensity

    up to 24 hours

  • Quality of Recovery (QoR)

    Postoperative 24th hour

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

    30 minutes post injection

Study Arms (2)

Sub-omohyoidal Plane Block

EXPERIMENTAL

Patients randomized to receive sub-omohyoid plane block.

Other: Sub-omohyoidal Plane Block

Costoclavicular Block plus Cervical Plexus Block

EXPERIMENTAL

Patients randomized to receive costoclavicular brachial and cervical plexus block.

Other: Cervical Plexus BlockOther: Costoclavicular Block

Interventions

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.

Sub-omohyoidal Plane 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 plus Cervical Plexus Block

Costoclavicular brachial plexus block will be applied by administering 20 mL of local anesthetic under ultrasound guidance. This block will be performed preoperatively.

Costoclavicular Block plus Cervical Plexus Block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists (ASA) classification I-II-III
  • Scheduled for arthroscopic shoulder surgery under general anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University

Samsun, 55090, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 23086351BACKGROUND
  • 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.

    PMID: 27956687BACKGROUND
  • 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.

    PMID: 30635497BACKGROUND
  • 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.

    PMID: 32044802BACKGROUND
  • 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.

    PMID: 25899958BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Interventions

Cervical Plexus Block

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nerve BlockAnesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Serkan Tulgar

    Samsun University Faculty of Medicine, Samsun Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
The patient and the anesthesiologist who performs postoperative pain evaluation will not know the group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2023

First Posted

January 13, 2023

Study Start

January 13, 2023

Primary Completion

May 24, 2024

Study Completion

May 24, 2024

Last Updated

May 28, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations