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Post-Operative Analgesic Efficacy Of Ultrasound Guided Pericapsular Nerve Group Block Versus Combined Suprascapular And Axillary (Circumflex) Nerve Block For Patients Undergoing Shoulder Arthroscopy

Primary Purpose

Post Operative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ultrasound guided pericapsular nerve group shoulder block
ultrasound guided suprascapular and axillary nerve block
general anesthesia without nerve block
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults between age of 18 and 60 years old undergoing elective shoulder arthroscopy surgery. American society of anesthesiologists classification (ASA) Ⅰ&Ⅱ Males & Females Exclusion Criteria: Age: < 18 or > 60 years old. Patients refuse to participate in the study. Patients with known hypersensitivity to local anesthetics. Coagulation disorder Infection at the site of injection Hepatic impairment Renal impairment Severe intraoperative bleeding affecting the hemodynamics status of the patient.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group A (ultrasound guided pericapsular nerve group shoulder block)

    Group B( ultrasound guided suprascapular and axillary nerve block)

    control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    visual analogue score
    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
    visual analogue score
    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
    visual analogue score
    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
    visual analogue score
    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
    visual analogue score
    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
    visual analogue score
    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
    visual analogue score
    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
    visual analogue score
    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
    visual analogue score
    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain

    Secondary Outcome Measures

    Time time to first dose of rescue analgesic
    Total dose of analgesic needed
    Complications
    number of participants developed complications

    Full Information

    First Posted
    March 17, 2023
    Last Updated
    March 17, 2023
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05791058
    Brief Title
    Post-Operative Analgesic Efficacy Of Ultrasound Guided Pericapsular Nerve Group Block Versus Combined Suprascapular And Axillary (Circumflex) Nerve Block For Patients Undergoing Shoulder Arthroscopy
    Official Title
    Post-Operative Analgesic Efficacy Of Ultrasound Guided Pericapsular Nerve Group Block Versus Combined Suprascapular And Axillary (Circumflex) Nerve Block For Patients Undergoing Shoulder Arthroscopy: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 20, 2023 (Anticipated)
    Primary Completion Date
    May 20, 2023 (Anticipated)
    Study Completion Date
    May 20, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Recently, the Combined suprascapular nerve block and axillary nerve block (SSNB+ANB) was proposed to provide anesthesia and postoperative analgesia for shoulder surgery as a safe alternative to interscalene block. These two peripheral nerves are responsible for the majority of the sensory innervation of the shoulder. PENG block has been studied extensively in hip surgeries, but its place in shoulder surgeries is not yet clear. It is a new technology reported for block of articular branches of the shoulder and well pericapsular spread around the glenohumeral joint Therefore, achieving pain relief while avoiding motor block allows us not only to provide an early rehabilitation program in the postoperative period, but also to control the chronic nociceptive activation secondary to pain-induced movement
    Detailed Description
    Preoperative: Routine preoperative assessment will be done before operation to all patients including history, clinical examination and laboratory investigations (complete blood picture, kidney function tests, liver function tests, pro-thrombin time, and partial thromboplastin time). Chest X-ray, electrocardiogram [ECG] will be done for patients above 40 years old. All patients will be informed about the study design and objectives as well as tools and techniques. Informed consent will be signed by every patient prior to inclusion in the study. All patients will be informed about the analgesic regimen and will be instructed on how to express pain intensity with use of the visual analogue scale (VAS) (10cm unmarked line in which 0=no pain, 10cm=the worst imaginable pain) Anesthetic techniques: General Anesthesia Technique: Pre-medications will be given to every patient of the two including groups in the form of midazolam (0.05 mg/kg, IV) together with omeprazole (40 mg, IV) and ondansetron (4 mg, IV) on arrival to the operative room after establishing a peripheral intravenous access. Vital signs will be continuously monitored. After pre-oxygenation for 3 minutes, general anesthesia is induced to all patients with fentanyl (1-2 μg/kg, IV), propofol (1-2mg/Kg, IV), and atracurium (0.5mg/Kg, IV) to facilitate endotracheal intubation. Intermittent positive pressure ventilation of both lungs will be applied (to maintain O2 saturation >98% and end tidal carbon dioxide measurement around 35-38 mmHg). Maintenance of anesthesia will be achieved using intermittent positive pressure ventilation with inhalation of 1-1.5% isoflurane in 50% O2 and atracurium (0.1mg/Kg, IV) every 30 minutes to maintain muscle relaxation. Ultrasound guided PENG shoulder block Technique (Group A): The patient's arm is placed in external rotation and abducted at 45 degrees. A linear ultrasound probe will be placed longitudinally between the coracoid and the humeral head. After defining the humeral head, the tendon of the subscapular muscle and the deltoid muscle over it, a 50-mm needle will be inserted using the ''in plane'' technique. When the needle pass through the deltoid muscle and touched the subscapularis tendon, a bone-like hard tissue will be felt and the needle could not be advanced further. The needle tip will be placed between the deltoid muscle and subscapularis tendon, and 20 cc of 0.25% bupivacaine hydrochloride with 4mg dexamesathone will be injected. Ultrasound guided combined suprascapular nerve block and axillary nerve block (SSNB+ANB) Technique (Group B): The ultrasound guided suprascapular nerve block: The patient will be positioned in a semi-recumbent position with the operating arm on the contralateral shoulder. The probe will be kept over the scapular spine to identify the trapezius and the supraspinatus muscle. Then, it will be moved laterally to identify the concavity of the supraspinatus fossa and the hyper-echoic fascia of the supraspinatus muscle. In the concavity of the fossa, the suprascapular artery and the suprascapular nerve run in close proximity. 10 ml of 0.25% bupivacaine with 2mg dexamethasone will be injected below the supraspinatus fascia. The ultrasound guided axillary nerve block: The patients is positioned in a semi-recumbent position with the arm slightly flexed and adducted at the elbow. The posterior surface of the humerus will be visualised in the short axis view. So, the AN and posterior circumflex artery will be visualised longitudinally. 10 ml of 0.25% bupivacaine with 2mg dexamethasone will be injected into space. The blocks will be considered a failed block if the block is not successful 30 min after the injection of the local anaesthetic. Group A 20 Patients of this group will receive ultrasound guided pericapsular nerve group shoulder block (PENG Block) at the end of surgery using 20 ml of 0.25% bupivacaine with 4mg dexamethasone with a maximum dose of (3mg/kg). Group B 20 Patients of this group will receive single shot suprascapular and axillary nerve using a single dose of 10ml of 0.25% bupivacaine with 2mg dexamethasone each at the end of surgery for postoperative pain relief. Group C 20 patients of this group will receive general anesthesia without nerve block. In the post anesthesia care unit (PACU) for first hour and in ward afterwards , all patients will be assessed for presence and severity of pain at at 1, 2, 4, 6, 8, 10, 12, 24, 36 and 48 hours postoperatively or at any time patient suffers from pain with visual analog score and recording its value at any patient visit. Nalbuphine 0.1 mg/kg is the rescue analgesic that will be given to any patient who will suffer pain with VAS more than 3.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Operative Pain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A (ultrasound guided pericapsular nerve group shoulder block)
    Arm Type
    Active Comparator
    Arm Title
    Group B( ultrasound guided suprascapular and axillary nerve block)
    Arm Type
    Active Comparator
    Arm Title
    control group
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    ultrasound guided pericapsular nerve group shoulder block
    Intervention Description
    The patient's arm is placed in external rotation and abducted at 45 degrees. A linear ultrasound probe will be placed longitudinally between the coracoid and the humeral head. After defining the humeral head, the tendon of the subscapular muscle and the deltoid muscle over it, a 50-mm needle will be inserted using the ''in plane'' technique. When the needle pass through the deltoid muscle and touched the subscapularis tendon, a bone-like hard tissue will be felt and the needle could not be advanced further. The needle tip will be placed between the deltoid muscle and subscapularis tendon, and 20 cc of 0.25% bupivacaine hydrochloride with 4mg dexamesathone will be injected
    Intervention Type
    Procedure
    Intervention Name(s)
    ultrasound guided suprascapular and axillary nerve block
    Intervention Description
    The patient will be positioned in a semi-recumbent position with the operating arm on the contralateral shoulder. The probe will be kept over the scapular spine to identify the trapezius and the supraspinatus muscle. Then, it will be moved laterally to identify the concavity of the supraspinatus fossa and the hyper-echoic fascia of the supraspinatus muscle. In the concavity of the fossa, the suprascapular artery and the suprascapular nerve run in close proximity. 10 ml of 0.25% bupivacaine with 2mg dexamethasone will be injected below the supraspinatous fascia then the posterior surface of the humerus will be visualised in the short axis view. So, the AN and posterior circumflex artery will be visualised longitudinally. 10 ml of 0.25% bupivacaine with 2mg dexamethasone will be injected into space
    Intervention Type
    Other
    Intervention Name(s)
    general anesthesia without nerve block
    Intervention Description
    this group will receive general anesthesia without nerve block
    Primary Outcome Measure Information:
    Title
    visual analogue score
    Description
    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
    Time Frame
    immediately after extubation
    Title
    visual analogue score
    Description
    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
    Time Frame
    2 hours postoperative
    Title
    visual analogue score
    Description
    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
    Time Frame
    4 hours postoperative
    Title
    visual analogue score
    Description
    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
    Time Frame
    8 hours postoperative
    Title
    visual analogue score
    Description
    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
    Time Frame
    12 hours postoperative
    Title
    visual analogue score
    Description
    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
    Time Frame
    16 hours postoperative
    Title
    visual analogue score
    Description
    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
    Time Frame
    24 hours postoperative
    Title
    visual analogue score
    Description
    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
    Time Frame
    36 hours postoperative
    Title
    visual analogue score
    Description
    A scale from 0-10 was allocated with 0 representing no pain and 10 representing the worst imaginable pain
    Time Frame
    48 hours postoperative
    Secondary Outcome Measure Information:
    Title
    Time time to first dose of rescue analgesic
    Time Frame
    during 48 hours after operation
    Title
    Total dose of analgesic needed
    Time Frame
    during 48 hours after operation
    Title
    Complications
    Description
    number of participants developed complications
    Time Frame
    during 48 hours after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adults between age of 18 and 60 years old undergoing elective shoulder arthroscopy surgery. American society of anesthesiologists classification (ASA) Ⅰ&Ⅱ Males & Females Exclusion Criteria: Age: < 18 or > 60 years old. Patients refuse to participate in the study. Patients with known hypersensitivity to local anesthetics. Coagulation disorder Infection at the site of injection Hepatic impairment Renal impairment Severe intraoperative bleeding affecting the hemodynamics status of the patient.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Post-Operative Analgesic Efficacy Of Ultrasound Guided Pericapsular Nerve Group Block Versus Combined Suprascapular And Axillary (Circumflex) Nerve Block For Patients Undergoing Shoulder Arthroscopy

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