Pericapsular Nerve Group Block vs Interscalene Block for Shoulder Arthroscopy

NCT06208774 | Unknown

• 1 other identifier: N-403-2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare PENG block and LV-ISBP block in the incidence of phrenic nerve block, duration of postoperative analgesia, time to first analgesic request (VAS \> 30 mm), pain scores, and side effects.

Conditions

Anesthesia; Regional Anesthesia Morbidity; Shoulder Pain; Arthroscopy

Keywords

Shoulder; PENG; Interscalene block; Arthroscopy

Outcome Measures

Primary Outcomes (1)

• Incidence of phrenic nerve block

  Incidence of phrenic nerve block

  24 hours

Secondary Outcomes (4)

• First analgesic request

  24 hours postoperative

• Visual analogue pain score

  24 hours postoperatively.

• Total morphine requirements

  24 hours

• Type and time of surgery

  up to 4 hours

Study Arms (2)

LV-ISBP block Group (n=40): US-guided low volume interscalene brachial plexus block

EXPERIMENTAL

Patient in a semi-sitting position with the head tilted to the opposite side of the injection site. A linear US probe (4-12 MHz) will be placed parallel to the clavicle in the supraclavicular fossa, and the subclavian artery will be seen beating above the first rib.Then the probe will be moved cranially to identify the transverse process of the C7 vertebra at the level of the brachial plexus roots between the scalenus anterior and medius muscles.The needle will be inserted in a plane approach from lateral to medial to scalenus medius and C5-C6 brachial plexus roots. After negative aspiration, a total of 5 mL of bupivacaine 0.5% will be injected incrementally.

Procedure: Ultrasound-guided PENG or ISBP block

PENG block Group (n=40): US-guided pericapsular nerve group block for shoulder

ACTIVE COMPARATOR

The patient's arm was placed in external rotation and abducted at 45 degrees. A linear US probe (4-12 MHz) will be placed longitudinally between the coracoid and the humeral head, visualizing the deltoid muscle and subscapularis tendon. 22-gauge needle will be advanced in-plane into the fascial plane between the deltoid muscle and subscapularis tendon. The location of the needle tip will be confirmed by hydrodissection of inter-fascial planes with 3 ml of normal saline. After negative aspiration, a total of 20 mL of bupivacaine 0.5% will be injected in the fascial plane incrementally, aspirating every 5 ml.

Procedure: Ultrasound-guided PENG or ISBP block

Interventions

Ultrasound-guided PENG or ISBP block PROCEDURE

The diaphragmatic excursion will be measured in the supine position before the block and after surgery. A curvilinear US probe (5-7 MHz) will be placed at the subcostal area in the anterior axillary line, below the costal margin of the eighth and ninth ribs. The probe will be directed medially, cephalad, and dorsally to make the US beam reach the posterior third of the diaphragm perpendicularly. The probe will then be scanned along the long axis of the intercostal spaces, using the liver as the acoustic window on the right side and the spleen as on the left side. M-mode sampling line will be positioned perpendicularly to the diaphragm, and the diaphragmatic excursions could be measured during quiet and deep breathing.The measurement will be repeated three times, and the average value will be taken. After measurement of diaphragmatic excursion, patients will receive either a PENG block or an LV-ISBP block before induction of general anesthesia.

LV-ISBP block Group (n=40): US-guided low volume interscalene brachial plexus block; PENG block Group (n=40): US-guided pericapsular nerve group block for shoulder

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients scheduled for shoulder arthroscopy
• American Society of Anesthesiologists (ASA) status I and II
• Ages between 18 and 60 years.

You may not qualify if:

• Coagulopathy
• Infection at the injection site.
• Allergy to local anesthetics
• Severe cardiopulmonary disease (≥ASA III)
• Diabetic or other neuropathies
• Motor disorders
• Patients receiving opioids for chronic analgesic therapy.
• Inability to comprehend visual analogue scale (VAS).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo university Hospitals. kasralainy

Cairo, Governorate, 002, Egypt

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Nagy malak, MD

CONTACT

01552480258; nagymalak1234@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer anesthesia cairo university

Study Record Dates

• First Submitted: December 9, 2023
• First Posted: January 17, 2024
• Study Start: December 20, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

EG (1)