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
About this trial
This is an interventional prevention trial for Post Operative Pain
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.
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
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