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AnesthesiaNCT06208774

Pericapsular Nerve Group Block vs Interscalene Block for Shoulder Arthroscopy

A study testing Ultrasound-guided PENG or ISBP block in people with Anesthesia and Regional Anesthesia Morbidity, run by Cairo University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
Ultrasound-guided PENG or ISBP block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteEgypt
Study dates
20 Dec 2023to 30 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Egypt1 site, 1 recruiting
  • Cairo university Hospitals. kasralainy

    Cairo, Governorate, 002

    Nagy malak, 01552480258, nagymalak12345@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: Pericapsular Nerve Group Block vs Low Volume Interscalene Brachial Plexus Block for Shoulder Arthroscopy: A Randomized Controlled Trial

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.

Read the detailed description

This randomized, controlled, double-blinded trial will be conducted in a Cairo University hospital.On arrival of the patients in the regional anesthesia room, they will be secured with a 20-gauge intravenous cannula. Monitoring will include ECG, non-invasive arterial blood pressure, and pulse oximetry (SpO2).

Before receiving the blocks, patients will be randomly assigned to one of the two study groups for diaphragmatic movement assessment:

The diaphragmatic excursion will be measured in the supine position before the block and after surgery by a blinded operator. A curvilinear ultrasound 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 ultrasound 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 the acoustic window on the left side. The M-mode sampling line will be positioned perpendicularly to the diaphragm, and the diaphragmatic excursions could be measured during quiet and deep breathing. The distance between the resting expiratory position and the maximum deep inspiration position will be measured. 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, and to achieve double blinding, patients will receive the block by consultant anesthesiologists who have experience in regional anesthesia. Another doctor not involved in the block procedure will evaluate the patient intraoperatively and postoperatively.

PENG block group (n = 40): this group will receive an ultrasound-guided pericapsular nerve group block for the shoulder with a total volume of 20 mL and 0.5% bupivacaine.

LV-ISBP block group (n = 40): this group will receive ultrasound-guided low-volume interscalene brachial plexus block with a total volume of 5 mL and 0.5% bupivacaine.

Technique of PENG Block:

The technique of ultrasound-guided PENG block will be performed with the patient's arm placed in external rotation and abducted at 45 degrees. A linear ultrasound probe (4-12 MHz) will be placed longitudinally between the coracoid and the humeral head, visualizing the deltoid muscle and subscapularis tendon. A 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.

Technique of the LV-ISBP block:

The technique of ultrasound-guided LV-ISBP will be performed with the patient in a semi-sitting position with the head tilted to the opposite side of the injection site. A linear ultrasound 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. A volume of 2 mL of 2% lignocaine will be infiltrated subcutaneously before the block. The needle will be inserted in a plane approach from lateral to medial to scalenus medius and C5-C6 brachial plexus roots. The location of the needle tip will be confirmed by hydrodissection with 1 ml of normal saline. After negative aspiration, a total of 5 mL of bupivacaine 0.5% will be injected incrementally, aspirating every 2.5 mL.

To ensure blind assessment, a dressing will be placed to cover a standard area that will cover the puncture sites regardless of which block is performed.

In the operating room, induction of general anesthesia will be induced after adequate preoxygenation using 1 µg/kg fentanyl, 2 mg/kg propofol, and 0.5 mg/kg atracurium, in addition to 8mg IV dexamethasone for the prevention of postoperative nausea and vomiting. Endotracheal intubation will be established. Anesthesia will be maintained by 1.2% MAC of isoflurane with oxygen (50%) in the air, and 0.1 mg/kg of atracurium will be administered every 20 minutes as maintenance anesthetic drugs. Volume-controlled ventilation will be maintained, and the respiratory rate will be adapted to maintain ET CO2 between 35 and 40 mmHg. Monitoring through ECG, NIBP, pulse oximetry, and capnography (ETCO2) continued throughout the surgeries. Each portal skin of the arthroscopy will be infiltrated by the surgeon with approximately 4 mL of 0.25% bupivacaine. Intraoperative inadequate analgesia, indicated by an increase in HR or mean arterial blood pressure (MAP) more than 20% above preinduction baseline values, will be managed using incremental 50-microgram doses of fentanyl. Intraoperative fentanyl consumption will be calculated. All patients will receive ketorolac 30mg IV and paracetamol 1 mg for postoperative analgesia. At the end of surgery, muscle relaxants will be reversed using neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Awake extubation will be established after adequate reversal of the neuromuscular block.

Patients will be transported to the post-anesthesia care unit (PACU) for one hour before being shifted to the ward. In the PACU, after the patient regains full consciousness, the diaphragmatic movement will be reassessed in the exact same manner as preoperatively. Phrenic nerve block is defined as failure of the diaphragm to achieve 25% of the pre-block excursion value.

Postoperative pain will be assessed using VAS (where 0 corresponds to no pain and 100 mm to the worst pain) at 2, 4, 6, 12, 18, and 24 hours postoperatively.

Postoperatively, in the ward, all patients will receive 1 g paracetamol every 6 h and 30 mg ketorolac every 12 h. If the VAS score is > 30 mm, IV morphine increments (2 mg) will be given to maintain VAS ≤ 30 mm with a maximum total 24-hour morphine consumption of 10 mg, and total morphine consumption will be recorded.

Being tested
Ultrasound-guided PENG or ISBP block
Keywords
Shoulder, PENG, Interscalene block, Arthroscopy
Medical subject headings
Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound-guided PENG or ISBP blockProcedure or surgery

    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.

Study groups in NCT06208774
Study groupRoleWhat they receive
LV-ISBP block Group (n=40): US-guided low volume interscalene brachial plexus blockExperimentalPatient 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.
Receives: Procedure: Ultrasound-guided PENG or ISBP block
PENG block Group (n=40): US-guided pericapsular nerve group block for shoulderActive comparatorThe 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.
Receives: Procedure: Ultrasound-guided PENG or ISBP block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of phrenic nerve block

    Incidence of phrenic nerve block

    Measured: 24 hours

Secondary outcomes (4)
  1. First analgesic request

    Time to first analgesic request (Visual analogue pain> 40 mm)

    Measured: 24 hours postoperative

  2. Visual analogue pain score

    Visual analogue pain score for pain assessment (from 0 the Best to 100 the worst) at 2, 4, 6, 12, 18, and 24 hours postoperatively

    Measured: 24 hours postoperatively.

  3. Total morphine requirements

    Total morphine requirements 24 hours postoperatively.

    Measured: 24 hours

  4. Type and time of surgery

    Type and time of surgery

    Measured: up to 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2024
  2. Study start20 Dec 2023
  3. Primary completion30 May 2024 (estimated)
  4. Study completion30 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06208774
Sponsor's protocol ID
N-403-2023
Status last verified
Jan 2024
First submitted
9 Dec 2023
Last updated
17 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound-guided PENG or ISBP block in people with Anesthesia and Regional Anesthesia Morbidity, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nagy malak, MD (01552480258, nagymalak1234@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of phrenic nerve block (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.

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