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

NCT05580094 | Completed DMC

• 1 other identifier: supraclavicular block and GA
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• brachiocephalic fistula maturation time

  time in weeks required by fistula to be clinically mature

  6 month postoperative

Secondary Outcomes (4)

• anaesthetic consumption

  90 minutes intraoperative

• postoperative analgesia time

  24 hours postoperative

• EMERGENCE agitation

  30 minutes postoperative

• VAS score

  24h postoperative

Study Arms (2)

General anesthesia only.

PLACEBO COMPARATOR

the pediatric patients will receive general anesthesia only.

Other: general anesthesia only.

General anesthesia plus supraclavicular block.

ACTIVE COMPARATOR

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

Other: general anesthesia plus supraclavicular block.

Interventions

general anesthesia only. OTHER

induction of general anesthesia by propofol and maintenance sevoflurane.

General anesthesia only.

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.

General anesthesia plus supraclavicular block.

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Egypt

Asyut, 71515, Egypt

Location

Related Publications (4)

• 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.

  PMID: 26171895 BACKGROUND

• 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.

  PMID: 24907283 BACKGROUND

• 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.

  PMID: 18544144 BACKGROUND

• Elsawy S, Fathy E, Elbadawy A, Elnaggar A, Abdelatif AF, Elmorabaa H, Hamed R. Ultrasound-guided supraclavicular brachial plexus block as an additive to sevoflurane anesthesia in pediatrics undergoing brachiobasilic arteriovenous fistula operation: randomized controlled clinical trial. BMC Anesthesiol. 2025 May 16;25(1):248. doi: 10.1186/s12871-025-03091-1.

  PMID: 40380096 DERIVED

Related Links

• Anaesthesia for children with renal disease.

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Outcomes Assessor)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at anesthesia,icu and pain management department

Model Details: Randomized, double-blinded controlled trial.

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 14, 2022
• Study Start: November 14, 2022
• Primary Completion: July 10, 2023
• Study Completion: January 10, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

EG (1)