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CompletedNCT05580094Updated Nov 12, 2024

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

An interventional study of general anesthesia only. and general anesthesia plus supraclavicular block. in Post Operative Pain, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by Assiut University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
2 Years to 18 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 75 is close to the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patient known to have allergy to the studied drugs.
  • Patients with contraindications to regional anesthesia.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
75 participants (actual)

Study arms

  • Placebo comparator
    General anesthesia only.

    the pediatric patients will receive general anesthesia only.

    Other: general anesthesia only.

  • Active comparator
    General anesthesia plus supraclavicular block.

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

    Other: general anesthesia plus supraclavicular block.

Interventions

  • Othergeneral anesthesia only.

    induction of general anesthesia by propofol and maintenance sevoflurane.

  • Othergeneral anesthesia plus supraclavicular block.

    induction of general anesthesia by propofol and maintenance sevoflurane then the patients will receive the supraclavicular block with bupivacaine 0.5 ml per kg.

06

What researchers measure

Primary outcomes

  1. brachiocephalic fistula maturation time

    time in weeks required by fistula to be clinically mature

    Time frame: 6 month postoperative

Secondary outcomes

  1. anaesthetic consumption

    measurment of anesthesia MAC

    Time frame: 90 minutes intraoperative

  2. postoperative analgesia time

    Time frame: 24 hours postoperative

  3. EMERGENCE agitation

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

    Time frame: 30 minutes postoperative

  4. VAS score

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

    Time frame: 24h postoperative

07

Study locations

1 site
  • Egypt
    Assiut, 71515, Egypt
08

References and documents

Publications

  • 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. PubMed 26171895 ↗
  • 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. PubMed 24907283 ↗
  • 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. PubMed 18544144 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05580094
Lead sponsor
Assiut University
Responsible party
Esraa Fathy Radwan Abd Elzaher (Resident doctor at anesthesia,icu and pain management department, Assiut University) — Principal investigator
First posted
Oct 14, 2022
Start date
Nov 14, 2022
Primary completion
Jul 10, 2023
Completion
Jan 10, 2024
Last update
Nov 12, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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