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NCT Number: NCT05580094

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

* 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.

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Egypt

Asyut, 71515, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

general anesthesia only.

Other

induction of general anesthesia by propofol and maintenance sevoflurane.

general anesthesia plus supraclavicular block.

Other

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 outcomes

  1. brachiocephalic fistula maturation time

    Time frame: 6 month postoperative

    time in weeks required by fistula to be clinically mature

Secondary outcomes

  1. anaesthetic consumption

    Time frame: 90 minutes intraoperative

    measurment of anesthesia MAC

  2. postoperative analgesia time

    Time frame: 24 hours postoperative

  3. EMERGENCE agitation

    Time frame: 30 minutes postoperative

    RASS score used with -5 = deeply sedated and 4 = highly agitated

  4. VAS score

    Time frame: 24h postoperative

    scale of 10 points. zero= no pain and 10 = worest pain

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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.

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Oct 14, 2022
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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