The Effect of Dexamethasone Administration Route in Pediatric Brachial Plexus Block

Not Applicable

Not yet recruiting

• Conditions: Arm
• Interventions: Drug: perineural dexamethasone; Drug: intravenous dexamethasone

• Registration Number: NCT07061678
• Lead Sponsor: Poznan University of Medical Sciences

Brief Summary

This study aims to assess the impact of the administration route of dexamethasone (intravenous vs. perineural) on postoperative pain and inflammatory response in pediatric patients undergoing hip surgery. The primary outcome is postoperative pain intensity measured using an age-appropriate scale at multiple intervals. Secondary outcomes include inflammatory markers such as neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), opioid consumption, time-to-first rescue analgesia, and overall patient recovery. This randomized, double-blinded study seeks to improve pain management strategies and optimize anesthesia protocols in pediatric arm surgery.

Detailed Description

Pediatric arm surgery is a complex procedure that can result in significant postoperative pain and an inflammatory response. Effective pain management is critical in this population to promote early mobilization, reduce opioid consumption, and minimize adverse outcomes.

Dexamethasone is an adjuvant in regional anesthesia that prolongs analgesia and mitigates inflammation. However, the optimal administration route of dexamethasone in infraclavicular brachial plexus block for pediatric arm surgery remains unclear. This study is designed to compare the efficacy of intravenous versus perineural dexamethasone in prolonging postoperative analgesia and reducing inflammatory responses.

This prospective, randomized, double-blinded clinical trial will enroll pediatric patients undergoing elective hip surgery. Participants will be randomized into two groups: one group will receive intravenous dexamethasone, while the other will receive perineural dexamethasone administered as part of the infraclavicular brachial plexus block. All patients will receive standardized spinal anesthesia under mild sedation and infraclavicular brachial plexus block using a local anesthetic at a fixed concentration.

The primary outcome will be time to first request rescue analgesia. Secondary outcomes include the inflammatory response measured by NLR and PLR, postoperative pain intensity, assessed using an age-appropriate pain scale at predefined time intervals, total opioid consumption, and blood glucose levels.

Safety will be closely monitored throughout the study, with particular attention to potential complications such as local anesthetic systemic toxicity (LAST) or dexamethasone-related adverse events.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-08
• Study First Submitted QC: 2025-07-08
• Last Update Submitted: 2025-07-08
• Study First Posted: 2025-07-11
• Last Update Posted: 2025-07-11
• Study Start: 2025-08-01
• Primary Completion: 2025-12-30
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• children scheduled for arm/wrist/hand surgery
• body weight > 5kg

Exclusion Criteria

• infection at the site of the regional block,
• coagulation disorders,
• immunodeficiency,
• American Society of Anesthesiologists (ASA) physical status of IV or higher,
• history of regular steroid medication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
perinerual dexamethasone	perineural dexamethasone	infraclavicular brachial plexus block + perineural dexamethasone
intravenous dexamethasone	intravenous dexamethasone	infraclavicular brachial plexus block + intravenous dexamethasone

Primary Outcome Measures

Name	Time	Method
Time to first rescue opioid analgesia	48 hours after surgery	Time to first rescue opioid analgesia

Secondary Outcome Measures

Name	Time	Method
Total opioid consumption	48 hours after surgery	Total opioid consumption in milliequivalents of morphine
NRS	48 hours after surgery	The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."
Nerve damage	48 hours after surgery	Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome
NLR	48 hours after surgery	Neutrophile-to-lymphocyte ratio
PLR	48 hours after surgery	Platelet-to-lymphocyte ratio
glucose	48 hours after surgery	blood glucose levels

Trial Locations

Locations (1)

Poznan University of Medical Sciences; 🇵🇱 Poznan, Poland