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Pericapsular Nerve Group Block in Shoulder Surgery

Primary Purpose

Postoperative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pericapsular nerve group block
Sponsored by
Selcuk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring pericapsular nerve group block, postoperative pain, shoulder surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:Patients scheduled for elective arthroscopic shoulder surgery under general anesthesia Patients aged 18 to 65 years American Society of Anesthesiologists (ASA) physical status value I-III patients - Exclusion Criteria: coagulopathy, neuropathy, use of anticoagulants, severe diabetes mellitus, local anesthetic and/or opioid allergy or sensitivity, a history of chronic pain, pre-existing psychiatric illness, can't understand pain scoring, Body mass index greater than 35 kg/m2, There is an infection in the body area to be blocked, Continuing follow-up and treatment in the intensive care unit, open shoulder surgery do not approve the informed consent form pregnant

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Pericapsular nerve group block (Group P)

    control group (Group C)

    Arm Description

    Pericapsular nerve group block will be performed with 20 ml of 0.5% bupivacaine hydrochloride before general anesthesia is applied to the patients in Group P.

    No block will be applied to patients in Group C.

    Outcomes

    Primary Outcome Measures

    To investigate the effect of pericapsular nerve group block on postoperative pain.
    Postoperative pain will be assessed using the NRS score (Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain) at 0, 4, 8, 12, and 24 hours.

    Secondary Outcome Measures

    Postoperative pain assessment is to evaluate time to first analgesia requirement, total amount of analgesic consumed, and complications.
    Demanded/administered analgesic ratio in PCA (patient control analgesia) device

    Full Information

    First Posted
    July 4, 2023
    Last Updated
    July 4, 2023
    Sponsor
    Selcuk University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05940454
    Brief Title
    Pericapsular Nerve Group Block in Shoulder Surgery
    Official Title
    Efficacy of Pericapsular Nerve Group Block in the Prevention of Postoperative Pain in Shoulder Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2023 (Anticipated)
    Study Completion Date
    November 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

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

    5. Study Description

    Brief Summary
    Dear Patient, You have been scheduled for shoulder surgery by your surgeon. This surgery is performed under general anesthesia, that is, by putting the patient to sleep, and then moderate or severe pain is experienced. In order to prevent this post-operative pain, painkillers are given through the vascular access or the operated area, namely the shoulder, is locally anesthetized. Many techniques are used to numb the shoulder locally. One of these techniques is the pericapsular nerve group block and it is a newly defined technique. In this block, some of the nerves that carry the pain sensation of the shoulder are temporarily anesthetized with local anesthetics. This study will investigate how effective this block is in reducing pain associated with shoulder surgery.
    Detailed Description
    Dear Patient, You have been scheduled for shoulder surgery by your surgeon. This surgery is performed under general anesthesia, that is, by putting the patient to sleep, and then moderate or severe pain is experienced. In order to prevent this pain to be experienced, analgesics are given through the vascular access or the operated area, namely the shoulder, is locally anesthetized. Different techniques are used to numb the shoulder locally. One of these techniques is pericapsular nerve group block. In this block, some of the nerves that carry the pain sensation of the shoulder are temporarily anesthetized with local anesthetics. Thus, it is aimed to reduce post-operative pain. In this study, we plan to investigate how effective the pericapsular nerve group block is on postoperative pain. In this scientific study, patients will be randomly divided into two groups. Pericapsular nerve group block will be applied to one group of patients, while the other group will not be blocked. Pain medication will be administered intravenously to both groups before waking them up, and at the same time, a device called 'Patient Controlled Analgesia' (PCA) containing a very strong pain medication will be inserted in all patients in the service. This device; It is a device that contains analgesics and gives analgesics to the patient through the vascular access according to the patient's request, and it works with the help of a button on it. When the patient feels pain, he will press the button and the device will give the medicine to the patient in a predetermined dose and time. The device records the total amount of pain medication sent in 24 hours on its screen. The amount of medication delivered by this device will be compared between patients with and without block. Thus, the effect of pericapsular nerve group block on postoperative pain will be investigated. What are the procedures to be applied in the research? The surgery that will be applied to you is performed under general anesthesia. Pericapsular nerve group block, which is one of the pain relief methods we apply for shoulder surgery; It involves administering a local anesthetic drug with the help of a needle between the muscles in the shoulder and numbing your shoulder area. After the blocking procedure, painful stimulus will be given and it will be checked whether you have pain and loss of sensation and what it is worth. If there is loss of feeling, the block will be considered successful. After the evaluation of the block procedure is completed, you will be given general anesthesia, that is, you will be put to sleep. At the end of the surgery and at the 4th, 8th, 12th and 24th hours after the surgery, the severity of your pain will be evaluated and the total amount of analgesic consumed will be recorded. A scale that includes scoring pain between 0 and 10, called "NRS (numerical rating scale)" will be used. With this scale, you will be asked to give a score between 0 and 10 according to the severity of the pain. 0 points; "no pain", 5 points; moderate pain, and 10 points means "the most severe pain the patient has ever felt".

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    pericapsular nerve group block, postoperative pain, shoulder surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pericapsular nerve group block (Group P)
    Arm Type
    Experimental
    Arm Description
    Pericapsular nerve group block will be performed with 20 ml of 0.5% bupivacaine hydrochloride before general anesthesia is applied to the patients in Group P.
    Arm Title
    control group (Group C)
    Arm Type
    No Intervention
    Arm Description
    No block will be applied to patients in Group C.
    Intervention Type
    Procedure
    Intervention Name(s)
    Pericapsular nerve group block
    Intervention Description
    The patient's arm is externally rotated and abducted at 45 degrees. A longitudinal linear ultrasound probe is placed between the coracoid and the humeral head. After defining the humeral head, the tendon of the subscapular muscle and the deltoid muscle on it, a 50 mm needle is inserted with the "in-plane" technique. When the needle passes through the deltoid muscle and touches the subscapularis tendon, a hard bone-like tissue is felt and the needle is not advanced any further. It is noteworthy that the subscapularis tendon is very rigid and resistant to needle penetration when performing the pericapsular nerve group block. The needle tip is placed between the deltoid muscle and the subscapularis tendon and a local anesthetic drug (20 ml, %0.5 bupivacain hydrochlorur) is injected
    Primary Outcome Measure Information:
    Title
    To investigate the effect of pericapsular nerve group block on postoperative pain.
    Description
    Postoperative pain will be assessed using the NRS score (Numerical Rating Scale (0 = no pain, 10 = worst imaginable pain) at 0, 4, 8, 12, and 24 hours.
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Postoperative pain assessment is to evaluate time to first analgesia requirement, total amount of analgesic consumed, and complications.
    Description
    Demanded/administered analgesic ratio in PCA (patient control analgesia) device
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria:Patients scheduled for elective arthroscopic shoulder surgery under general anesthesia Patients aged 18 to 65 years American Society of Anesthesiologists (ASA) physical status value I-III patients - Exclusion Criteria: coagulopathy, neuropathy, use of anticoagulants, severe diabetes mellitus, local anesthetic and/or opioid allergy or sensitivity, a history of chronic pain, pre-existing psychiatric illness, can't understand pain scoring, Body mass index greater than 35 kg/m2, There is an infection in the body area to be blocked, Continuing follow-up and treatment in the intensive care unit, open shoulder surgery do not approve the informed consent form pregnant

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34118263
    Citation
    Kupeli I, Yazici Kara M. Anesthesia or analgesia? New block for shoulder surgery: pericapsular nerve group block. Braz J Anesthesiol. 2022 Sep-Oct;72(5):669-672. doi: 10.1016/j.bjane.2021.05.009. Epub 2021 Jun 9.
    Results Reference
    background
    PubMed Identifier
    34653775
    Citation
    Ramadurai R, Bhoi D, Nagarajappa A, Amar P. Pericapsular nerve group block (PENG) at neutral position for shoulder manipulation: A feasible approach for a new indication. J Clin Anesth. 2021 Dec;75:110541. doi: 10.1016/j.jclinane.2021.110541. Epub 2021 Oct 12. No abstract available.
    Results Reference
    background

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    Pericapsular Nerve Group Block in Shoulder Surgery

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