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Dexamedatomidine vs. Dexamethasone in Rhomboidal Intercostal Plain Block and Subserratus Block in Breast Surgery

Primary Purpose

Postoperative Pain, Acute

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Rhomboid Intercostal and Sub-Serratus block technique (RISS)
General Anaesthesia
dexamedatomidine
dexamethasone
saline
Sponsored by
Armed Forces College of Medicine, Cairo, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain, Acute

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult female patient
  • Type of surgery; Modified Radical Mastectomy (MRM).
  • Physical status ASA II, III.
  • Age ≥ 21 and ≤ 65 Years.
  • Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.

Exclusion Criteria:

  • Patient refusal.
  • Patients suffering from coagulation disorders.
  • Patients with histories of allergic reactions to local anesthetics or dexmedetomidine.
  • Patients suffering from neuropsychiatric disorders.
  • Pregnancy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    dexamedatomidine

    dexamethasone

    saline

    Arm Description

    Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 1 Mcg/kg dexamedatomidine in 2 mL.

    Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 8mg dexamethasone in 2 mL.

    Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine+ 2 mL normal saline.

    Outcomes

    Primary Outcome Measures

    Time of first request of analgesia.
    calculated from the time of complete injection of local anesthetics till the numerical rating scale (is more than or equals 3

    Secondary Outcome Measures

    Total amount of morphine consumption
    mean arterial blood pressure
    heart rate
    Numerical rating scale
    The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

    Full Information

    First Posted
    May 18, 2022
    Last Updated
    May 25, 2022
    Sponsor
    Armed Forces College of Medicine, Cairo, Egypt
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05385523
    Brief Title
    Dexamedatomidine vs. Dexamethasone in Rhomboidal Intercostal Plain Block and Subserratus Block in Breast Surgery
    Official Title
    Comparison Between Analgesic Effect of Adding Dexamedatomidine or Dexamethasone to Bupvicaine in Rhomboidal Intercostal Plain Block and Subserratus Block in Breast Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 20, 2022 (Anticipated)
    Primary Completion Date
    November 1, 2022 (Anticipated)
    Study Completion Date
    November 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Armed Forces College of Medicine, Cairo, Egypt

    4. Oversight

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

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate the analgesic efficacy and safety of adding dexmedetomidine and dexamethasone to bupivacaine in rhomboidal intercostal and subserratus (RISS) block for patients undergoing modified radical mastectomy compared to bupivacaine only.
    Detailed Description
    Rhomboid intercostal block (RIB); a new interfascial plane block involves the triangle of auscultation that's bounded medially by inferior a part of the trapezius, inferiorly by the superior border of latissimus dorsi, and laterally by the medial border of the scapula. The local anaesthetic spreads between the rhomboid major and therefore the intercostal fascia at the extent of T6-T7 and provides analgesia of T3-T8 dermatomes. Aiming to expand dermatomal coverage, a new modification of Rhomboid Intercostal and Sub-Serratus block (RISS) is performed by advancing the ultrasound probe caudally and laterally distal to the inferior angle of the scapula, the second injection apply between the serratus and intercostal muscle fascia. The RISS block is a novel ultrasound-guided block that has been shown to provide analgesia from T2-T11 dermatomes. Dexmedetomidine is a potent selective α 2 adrenoceptor agonist that was reported in many previous studies as an adjunct to regional and general anesthesia, with significant prolongation of the duration of sensory block, motor block and analgesia, and accelerate the time to onset of sensory and motor block when added to a local anesthetic. Dexamethasone is a potent long-acting steroid that has shown efficacy as an adjuvant to local anesthetics in various studies. It enhances peripheral nerve blocks when added to local anesthetics, providing better quality of anesthesia as well as postoperative analgesia. The mechanism by which dexamethasone prolong the duration of local anesthetics are not completely understood; however, some studies demonstrated that dexamethasone exerts its action through reducing the release of inflammatory mediators and by inhibiting discharge of C-fibers.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain, Acute

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    dexamedatomidine
    Arm Type
    Experimental
    Arm Description
    Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 1 Mcg/kg dexamedatomidine in 2 mL.
    Arm Title
    dexamethasone
    Arm Type
    Experimental
    Arm Description
    Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 8mg dexamethasone in 2 mL.
    Arm Title
    saline
    Arm Type
    Experimental
    Arm Description
    Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine+ 2 mL normal saline.
    Intervention Type
    Procedure
    Intervention Name(s)
    Rhomboid Intercostal and Sub-Serratus block technique (RISS)
    Intervention Description
    The patient will be placed in lateral position. A linear ultrasound transducer of frequency 6-12 MHz will be placed medial to the lower border of the scapula in a sagittal plane. A 38-mm 22-gauge will be inserted under real-time in-plane from craniocaudal between the rhomboid major and intercostal muscles. After negative aspiration, single injection of 10 ml of the local anesthetic mixture will be administered at the T6 7 level. The spread of local anesthetic solution under the rhomboid muscle will be visualized by ultrasonography. Then the ultrasound probe will be moved caudally and laterally to identify the tissue plane between the serratus anterior and external intercostal muscle for the sub-serratus block at T 8-9 level. The needle will be advanced from its previous position and a further of 10 ml of the local anesthetic mixture will be injected.
    Intervention Type
    Procedure
    Intervention Name(s)
    General Anaesthesia
    Intervention Description
    Fentanyl (1 μg/kg), propofol (2-3mg/kg) and atracurium (0.3-0.5 mg/kg) will be injected intravenously 3-5 minutes after oxygenation. A single-lumen endotracheal tube will be used to complete ventilation. The ventilator ventilation mode is volume control mode, and the patient's end-expiratory carbon dioxide level is maintained at 35-40 mmHg throughout the anesthesia process. During the anesthesia maintenance phase, 2% sevoflurane mixed with 60% oxygen. After general anaesthesia induction, all patients will receive RISS block with different local anesthetic drug mixture according to randomization.
    Intervention Type
    Drug
    Intervention Name(s)
    dexamedatomidine
    Intervention Description
    Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 1 Mcg/kg dexamedatomidine in 2 mL.
    Intervention Type
    Drug
    Intervention Name(s)
    dexamethasone
    Intervention Description
    Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 8mg dexamethasone in 2 mL.
    Intervention Type
    Drug
    Intervention Name(s)
    saline
    Intervention Description
    Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine+ 2 mL normal saline.
    Primary Outcome Measure Information:
    Title
    Time of first request of analgesia.
    Description
    calculated from the time of complete injection of local anesthetics till the numerical rating scale (is more than or equals 3
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Total amount of morphine consumption
    Time Frame
    24 hours
    Title
    mean arterial blood pressure
    Time Frame
    24 hours
    Title
    heart rate
    Time Frame
    24 hours
    Title
    Numerical rating scale
    Description
    The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult female patient Type of surgery; Modified Radical Mastectomy (MRM). Physical status ASA II, III. Age ≥ 21 and ≤ 65 Years. Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2. Exclusion Criteria: Patient refusal. Patients suffering from coagulation disorders. Patients with histories of allergic reactions to local anesthetics or dexmedetomidine. Patients suffering from neuropsychiatric disorders. Pregnancy.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bassant Abdelhamid, MD
    Phone
    001224254012
    Email
    Bassantmohamed197@yahoo.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Abdullah Homouda
    Phone
    001276745271
    Email
    Abdallahhamouda71@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bassant Abdelhamid, MD
    Organizational Affiliation
    AFCM Egypt
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26330711
    Citation
    Kaur H, Singh G, Rani S, Gupta KK, Kumar M, Rajpal AS, Aggarwal S. Effect of dexmedetomidine as an adjuvant to levobupivacaine in supraclavicular brachial plexus block: A randomized double-blind prospective study. J Anaesthesiol Clin Pharmacol. 2015 Jul-Sep;31(3):333-8. doi: 10.4103/0970-9185.161668.
    Results Reference
    background
    PubMed Identifier
    28033159
    Citation
    Bjorn S, Linde F, Nielsen KK, Borglum J, Hauritz RW, Bendtsen TF. Effect of Perineural Dexamethasone on the Duration of Single Injection Saphenous Nerve Block for Analgesia After Major Ankle Surgery: A Randomized, Controlled Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):210-216. doi: 10.1097/AAP.0000000000000538.
    Results Reference
    background
    PubMed Identifier
    30703673
    Citation
    Elsharkawy H, Ince I, Pawa A. Rhomboid intercostal and sub-serratus (RISS) plane block for analgesia after lung transplant. J Clin Anesth. 2019 Sep;56:85-87. doi: 10.1016/j.jclinane.2019.01.042. Epub 2019 Jan 28. No abstract available.
    Results Reference
    result

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    Dexamedatomidine vs. Dexamethasone in Rhomboidal Intercostal Plain Block and Subserratus Block in Breast Surgery

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