Actively Recruiting

Phase Not Applicable
Age: 3Years - 12Years
All Genders
NCT07289620

Dexamethasone vs Dexmedetomidine vs Combination as Adjuvants to Popliteal Sciatic Nerve Block in Children

Led by Poznan University of Medical Sciences · Updated on 2026-02-02

120

Participants Needed

1

Research Sites

54 weeks

Total Duration

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AI-Summary

What this Trial Is About

This clinical study will evaluate three commonly used medications that can be added to local anesthetic during a popliteal sciatic nerve block in children undergoing surgery of the lower leg or foot. These medications-dexamethasone, dexmedetomidine, or a combination of both-may help the nerve block last longer and provide better postoperative pain control. All participating children will receive a standard popliteal sciatic nerve block with ropivacaine, a commonly used local anesthetic. They will then be randomly assigned to one of three groups: (1) ropivacaine with dexamethasone, (2) ropivacaine with dexmedetomidine, or (3) ropivacaine with both dexamethasone and dexmedetomidine. Neither the children, parents, nor the clinical staff assessing pain will know which medication was given. The goal of this study is to determine whether the combination of dexamethasone and dexmedetomidine provides longer pain relief and reduces the need for additional pain medication compared with either medication alone. The results may help identify the most effective and safest strategy for improving postoperative comfort in pediatric patients receiving regional anesthesia.

CONDITIONS

Official Title

Dexamethasone vs Dexmedetomidine vs Combination as Adjuvants to Popliteal Sciatic Nerve Block in Children

Who Can Participate

Age: 3Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 3 to 12 years
  • Scheduled for elective unilateral lower limb surgery (foot, ankle, or distal lower leg) with planned popliteal sciatic nerve block
  • ASA physical status I-III
  • Parents or legal guardians understand study procedures and provide written consent
  • Child and parents/guardians available for telephone follow-up at 1 week and 1 month after surgery
Not Eligible

You will not qualify if you...

  • Parents/legal guardians refuse consent or child refuses cooperation with anesthesia or study
  • Known allergy or sensitivity to ropivacaine, dexamethasone, dexmedetomidine, or study medication components
  • Pre-existing neurological or neuromuscular disease affecting lower limbs
  • Coagulopathy or current anticoagulation contraindicating regional anesthesia
  • Local infection, inflammation, or skin lesions at the block site
  • Severe heart, liver, kidney, or lung disease increasing study risk
  • History of significant arrhythmias, severe bradycardia, or untreated advanced heart block
  • Developmental delay or cognitive impairment preventing reliable pain assessment or follow-up
  • Chronic opioid or sedative use daily for 2 or more weeks before surgery
  • Participation in another interventional trial within 30 days
  • Any condition interfering with protocol adherence, safety, or reliable outcomes

AI-Screening

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Trial Site Locations

Total: 1 location

1

Poznan University of Medical Sciences

Poznan, Poland, 62-701

Actively Recruiting

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Research Team

M

Malgorzata Reysner, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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