search
Back to results

Combined Supraclavicular Block and General Anesthesia in Pediatric Patients With Chronic Kidney Disease

Primary Purpose

Post Operative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
general anesthesia only.
general anesthesia plus supraclavicular block.
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Operative Pain

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pediatric patients of less than 18 years old.
  • with chronic kidney disease.
  • undergoing upper limb superficialization of arteriovenous fistula for haemodialysis.

Exclusion Criteria:

  • Patient known to have allergy to the studied drugs.
  • Patients with contraindications to regional anesthesia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    General anesthesia only.

    General anesthesia plus supraclavicular block.

    Arm Description

    the pediatric patients will receive general anesthesia only.

    the pediatric patients will receive combined supraclavicular block and general anesthesia.

    Outcomes

    Primary Outcome Measures

    The intensity of postoperative pain
    Assessed by Modified CHEOPS (Children's Hospital of Eastern Ontario Pain Scale)

    Secondary Outcome Measures

    Full Information

    First Posted
    October 6, 2022
    Last Updated
    October 12, 2022
    Sponsor
    Assiut University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05580094
    Brief Title
    Combined Supraclavicular Block and General Anesthesia in Pediatric Patients With Chronic Kidney Disease
    Official Title
    Combined General Anesthesia and Ultrasound Guided Supraclavicular Block Versus General Anesthesia in Pediatric Patients With Chronic Kidney Disease Undergoing Upper Limb Superficialization of Arteriovenous Fistula.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 14, 2022 (Anticipated)
    Primary Completion Date
    December 15, 2023 (Anticipated)
    Study Completion Date
    December 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut 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
    compare the safety and efficacy of ultrasound-guided supraclavicular block in addition to general anesthesia in pediatric patients undergoing upper limb superficialization of arteriovenous fistula for hemodialysis. compare the amount of analgesic consumption as well as vasodilatation of upper limb blood vessels and its implications on the vascular anastomosis.
    Detailed Description
    Established renal disease is a significant cause of morbidity and mortality in children and has implications for the conduct of general anesthesia (1). Anesthetic management of pediatric patients is uniquely challenging. A large part of the anesthetic care includes pain management, management of concomitant disease, and risk reduction for adverse events. Perioperative pain management usually involves a multimodal pharmacologic approach to minimize opioid requirements. Regional anesthesia is valuable for postoperative pain control (2). Postoperative analgesia is dictated by the extent and nature of the surgery. Regional block should be utilized where possible for its opioid-sparing effects. Where morphine infusions are commenced, the dose should be reduced due to the risk of accumulation of active metabolites and resultant opiate toxicity. Non-steroidal anti-inflammatory drugs are always avoided due to their deleterious effects on urine output (3). Pediatric regional anesthesia is one of the most valuable and safe tools to treat perioperative pain and is an essential part of modern anesthetic practice. It provides excellent pain relief and allows caregivers to use multimodal analgesic techniques and decrease the use of opioids. Upper extremity brachial plexus blocks in children Various approaches to brachial plexus are available. The choice of the block is made depending on the indications. The supra-clavicular approach covers all the surgeries of the humerus and below (4). The use of regional anaesthesia is mostly associated with vasodilatation which may guard against arterial spasm and may play a role in decreasing the postoperative complication and success of the superficialization of the arteriovenous shunt as a line for hemodialysis.

    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
    Model Description
    Randomized, double-blinded controlled trial.
    Masking
    ParticipantOutcomes Assessor
    Masking Description
    Double (Participant, Outcomes Assessor)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    General anesthesia only.
    Arm Type
    Placebo Comparator
    Arm Description
    the pediatric patients will receive general anesthesia only.
    Arm Title
    General anesthesia plus supraclavicular block.
    Arm Type
    Active Comparator
    Arm Description
    the pediatric patients will receive combined supraclavicular block and general anesthesia.
    Intervention Type
    Other
    Intervention Name(s)
    general anesthesia only.
    Intervention Description
    induction of general anesthesia by propofol and maintenance sevoflurane.
    Intervention Type
    Other
    Intervention Name(s)
    general anesthesia plus supraclavicular block.
    Intervention Description
    induction of general anesthesia by propofol and maintenance sevoflurane then the patients will receive the supraclavicular block with bupivacaine 0.5 ml per kg.
    Primary Outcome Measure Information:
    Title
    The intensity of postoperative pain
    Description
    Assessed by Modified CHEOPS (Children's Hospital of Eastern Ontario Pain Scale)
    Time Frame
    24 hours after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Pediatric patients of less than 18 years old. with chronic kidney disease. undergoing upper limb superficialization of arteriovenous fistula for haemodialysis. Exclusion Criteria: Patient known to have allergy to the studied drugs. Patients with contraindications to regional anesthesia.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Esraa F. Radwan Abd Elzaher, master
    Phone
    01065603520
    Email
    fathyesraa295@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Saeid M. Elsawy, md
    Phone
    01030072161
    Email
    saeedelsawy17@gmail.com

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26171895
    Citation
    Manyande A, Cyna AM, Yip P, Chooi C, Middleton P. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2015 Jul 14;2015(7):CD006447. doi: 10.1002/14651858.CD006447.pub3.
    Results Reference
    background
    PubMed Identifier
    24907283
    Citation
    Suresh S, Schaldenbrand K, Wallis B, De Oliveira GS Jr. Regional anaesthesia to improve pain outcomes in paediatric surgical patients: a qualitative systematic review of randomized controlled trials. Br J Anaesth. 2014 Sep;113(3):375-90. doi: 10.1093/bja/aeu156. Epub 2014 Jun 6.
    Results Reference
    background
    PubMed Identifier
    18544144
    Citation
    De Jose Maria B, Banus E, Navarro Egea M, Serrano S, Perello M, Mabrok M. Ultrasound-guided supraclavicular vs infraclavicular brachial plexus blocks in children. Paediatr Anaesth. 2008 Sep;18(9):838-44. doi: 10.1111/j.1460-9592.2008.02644.x. Epub 2008 Jun 9.
    Results Reference
    background
    Links:
    URL
    https://doi.org/10.1093/bjaceaccp/mku064
    Description
    Anaesthesia for children with renal disease.

    Learn more about this trial

    Combined Supraclavicular Block and General Anesthesia in Pediatric Patients With Chronic Kidney Disease

    We'll reach out to this number within 24 hrs