Subomohyoid vs Costoclavicular Block in Shoulder Surgery

Sponsor
Samsun University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05683522
Collaborator
(none)
60
1
2
7.2
8.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Sub-omohyoidal Plane Block
  • Other: Cervical Plexus Block
  • Other: Costoclavicular Block
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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:
Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description:
The patient and the anesthesiologist who performs postoperative pain evaluation will not know the group.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 13, 2023
Anticipated Primary Completion Date :
Aug 15, 2023
Anticipated Study Completion Date :
Aug 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sub-omohyoidal Plane Block

Patients randomized to receive sub-omohyoid plane block.

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.

Experimental: Costoclavicular Block plus Cervical Plexus Block

Patients randomized to receive costoclavicular brachial and cervical plexus block.

Other: 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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. 24 hours opioid consumption [up to 24 hours]

    morphine consumptions for both group will be recorded

Secondary Outcome Measures

  1. Numeric rating scale for postoperative pain intensity [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

  2. Quality of Recovery (QoR) [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.

  3. Incidence of hemidiaphragm paralysis at 30 minutes after sub-omohyoid plan or costoclavicular plus cervical plexus block [30 minutes post injection]

    Ultrasound diagnosed hemidiaphragm paralysis

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsun University Samsun Turkey 55090

Sponsors and Collaborators

  • Samsun University

Investigators

  • Principal Investigator: Serkan Tulgar, Samsun University Faculty of Medicine, Samsun Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Serkan Tulgar, Principal Investigator, Samsun University
ClinicalTrials.gov Identifier:
NCT05683522
Other Study ID Numbers:
  • SamsunO
First Posted:
Jan 13, 2023
Last Update Posted:
Jan 17, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Serkan Tulgar, Principal Investigator, Samsun University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 17, 2023