The Effect of Dexamethasone Administration Route in Pediatric Brachial Plexus Block

Poznan University of Medical Sciences (PUMS)

Status and phase: Enrolling; Phase 4

Conditions: Arm

Treatments: Drug: 0.2ml/kg 0.2% ropivacaine; Drug: perineural dexamethasone; Drug: intravenous dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT07061678

5/2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 3 months to 6 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 3 patient groups, including a placebo group

perinerual dexamethasone

Active Comparator group

Description:

infraclavicular brachial plexus block + perineural dexamethasone

Treatment:

Drug: perineural dexamethasone

intravenous dexamethasone

Active Comparator group

Description:

infraclavicular brachial plexus block + intravenous dexamethasone

Treatment:

Drug: intravenous dexamethasone

0.2ml/kg 0.2% ropivacaine

Placebo Comparator group

Description:

infraclavicular brachial plexus block

Treatment:

Drug: 0.2ml/kg 0.2% ropivacaine