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

November 8, 2024 updated by: Esraa Fathy Radwan Abd Elzaher, Assiut University

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.

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71515
        • Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: General anesthesia only.
the pediatric patients will receive general anesthesia only.
Other: general anesthesia only.
induction of general anesthesia by propofol and maintenance sevoflurane.
Active Comparator: General anesthesia plus supraclavicular block.
the pediatric patients will receive combined supraclavicular block and general anesthesia.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
brachiocephalic fistula maturation time
Time Frame: 6 month postoperative
time in weeks required by fistula to be clinically mature
6 month postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative analgesia time
Time Frame: 24 hours postoperative
24 hours postoperative
anaesthetic consumption
Time Frame: 90 minutes intraoperative
measurment of anesthesia MAC
90 minutes intraoperative
EMERGENCE agitation
Time Frame: 30 minutes postoperative
RASS score used with -5 = deeply sedated and 4 = highly agitated
30 minutes postoperative
VAS score
Time Frame: 24h postoperative
scale of 10 points. zero= no pain and 10 = worest pain
24h postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2022

Primary Completion (Actual)

July 10, 2023

Study Completion (Actual)

January 10, 2024

Study Registration Dates

First Submitted

October 6, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 8, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • supraclavicular block and GA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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