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

Post Operative Pain Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05580094
• Other study ID #: supraclavicular block and GA
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: October 2022
• Source: Assiut University
• Contact: Esraa F. Radwan Abd Elzaher, master
• Phone: 01065603520
• Email: fathyesraa295[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Diseases
• Pain, Postoperative
• Post Operative Pain
• Renal Insufficiency, Chronic

Intervention

Other:
• general anesthesia only.
induction of general anesthesia by propofol and maintenance sevoflurane.
• general 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

De José María B, Banús E, Navarro Egea M, Serrano S, Perelló 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. — View 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;(7):CD006447. doi: 10.1002/14651858.CD006447.pub3. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The intensity of postoperative pain	Assessed by Modified CHEOPS (Children's Hospital of Eastern Ontario Pain Scale)	24 hours after surgery

External Links

•   Anaesthesia for children with renal disease.