Interscalene Block Versus Pericapsular Nerve Block and Superficial Cervical Plexus Block for Arthroscopic Shoulder Surgery

NCT05768009 | Unknown

• 1 other identifier: Interscalene block
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Interscalene brachial plexus block (ISB) is considered the standard nerve block for shoulder surgery . It provides superior analgesia and reduced opioid-related adverse effects . However, it is challenging to perform and may be associated with a high incidence of ipsilateral hemidiaphragmatic paresis, resulting from a phrenic nerve block . Although that complication could be decreased with modified local anesthetic dosing and ultrasound-guided needle placement , its incidence significantly impair the mechanics of breathing leading to postoperative morbidity, making that block undesirable in patients with impaired pulmonary functions . This clinical problem has recently received considerable attention, with several calls to seek alternatives to interscalene block in shoulder arthroscopy \[18\]. So, the need for a safer ISB alternative has prompted researchers to examine several options, including but not limited to the suprascapular \[19\] and pericapsular nerve blocks . Pericapsular nerve block has been studied extensively in hip surgeries , and some physicians suggested that it can be safely applied for analgesia and can be part of surgical anesthesia in shoulder arthroscopic surgery. It induces blockade of the articular branches that innervate the glenohumeral joint . The block of this area does not cause motor block or pulmonary complications, nor result in muscle laxity, blocking only the shoulder and the upper third of the humerus . The cervical plexus is formed by the ventral rami of C1-C4 cervical roots. It can be blocked at the superficial, intermediate and at the deep level \[24\]. The superficial cervical plexus block results in anesthesia of skin over the anterolateral neck, skin overlying the clavicle and the sternoclavicular joint, anterior and retroauricular areas . Although that block is effective in pain management after surgeries involving the distal clavicle, it has been poorly described in shoulder arthroscopy.

Conditions

Interscalene Block; Superficial Cervical Block

Keywords

Interscalene , Pericapsular Nerve Block , Superficial Cervical Plexus

Outcome Measures

Primary Outcomes (1)

• • The incidence of postoperative diaphragmatic paralysis

  The same diaphragmatic ultrasound measurements will be performed at PACU 30 minutes postoperative then 24 hours after the operation

  24 hour

Secondary Outcomes (2)

• • Postoperative pain will be assessed via the NRS, and its values will be recorded at PACU and then at, 2, 4, 6, 12, 18, 24 hour after arthroscopy.

  24 hour

• The total amount of analgesia and 1st rescue analgesia

  24 hour

Study Arms (2)

Interscalene brachial plexus block (ISB)

EXPERIMENTAL

• Group A will include 21 patients who will undergo the procedure under general anesthesia and ultrasound guided Interscalene brachial plexus block using 10 ml bupivacaine 0.25%.the interscalene block will be performed when the patient is in a supine position, with his/her head slightly elevated and turned away from the side to be blocked. The linear ultrasound probe (frequency 10-15 MHz) will be used with the depth setting of 2-4 cm. The probe will be initially placed near the midline of clavicle at the level of cricoid cartilage and scanned laterally to identify the carotid artery and internal jugular vein underneath the sternocleidomastoid muscle. By moving the probe laterally, the anterior scalene muscle will be identified below the lateral edge of the sternocleidomastoid. A groove containing the hypoechoic nerve structures will usually be identified. 10 mL of 0.25 bupivacaine will be injected into scalene groove around the nerve roots.

Procedure: Interscalene brachial plexus block (ISB)

pericapsular nerve block and superficial cervical plexus blocks

EXPERIMENTAL

• Group B will include 21 patients who will undergo the procedure under general anesthesia and combined pericapsular nerve block and superficial cervical plexus blocks (using 10 and 5 ml bupivacaine 0.25% respectively). the patient's arm will be placed in external rotation and abducted at 45 degrees. The linear ultrasound probe will be placed longitudinally between the coracoid process and the humeral head. After identification of the humeral head, the subscapularis tendon and the deltoid muscle over it, a 50-mm sonovisible needle will be inserted using the "in plane" technique. The needle tip will be placed between the deltoid muscle and subscapularis tendon, and 10 ml of 0.25% bupivacaine will be injected.

Procedure: Interscalene brachial plexus block (ISB)

Interventions

Interscalene brachial plexus block (ISB) PROCEDURE

• Group A will include 21 patients who will undergo the procedure under general anesthesia and ultrasound guided ISB using 10 ml bupivacaine 0.25%.

Interscalene brachial plexus block (ISB); pericapsular nerve block and superficial cervical plexus blocks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged between 18 and 65 years, Classification as class I or II according to the American Society of Anesthesiologists (ASA) , Patients scheduled for elective arthroscopic shoulder procedures.

You may not qualify if:

• Age beyond the previous limits.
• Refusal to participate in the study.
• Patients with peripheral neuropathy.
• Patients with chronic chest diseases affecting their pulmonary function results.
• ASA class \> II.
• Bleeding diathesis.
• Pregnancy.
• Recent history of anticoagulant or antiplatelet drug intake.
• Cutaneous infection at the injection site.
• Patients with pacemakers.
• Patients with AV block.
• Known allergy to local anesthetics.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, ELgharbiaa, 31527, Egypt

Location

Central Study Contacts

amr arafa elbadry

CONTACT

01283945351; amrarafa009@gmail.com

Laila Elahwal

CONTACT

01018484319; lailaelahwal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 14, 2023
• Study Start: March 25, 2023
• Primary Completion: September 25, 2023
• Study Completion: September 25, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

EG (1)