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

NCT07289620 | Recruiting

• 1 other identifier: 15/2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Foot Diseases; Ankle Disease

Outcome Measures

Primary Outcomes (1)

• Time to First Rescue Analgesia

  Time in hours from completion of the popliteal sciatic nerve block to the first administration of rescue analgesic medication. Rescue analgesia will be provided when the FLACC pain score is ≥ 4, or upon patient/parent request. This measure reflects the duration of effective postoperative analgesia provided by the nerve block.

  0-24 hours postoperatively

Secondary Outcomes (14)

• Total Opioid Consumption

  0-24 hours postoperatively

• FLACC Pain Scores at Rest

  2 hours postoperatively

• FLACC Pain Scores at Rest

  4 hours postoperatively

• FLACC Pain Scores at Rest

  8 hours postoperatively

• FLACC Pain Scores at Rest

  12 hours postoperatively

Study Arms (3)

Perineural Dexamethasone

ACTIVE COMPARATOR

Children in this arm will receive a single-shot popliteal sciatic nerve block performed under ultrasound guidance with 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg perineural dexamethasone (maximum dose per institutional pediatric guidelines). The block will be performed using a 22-gauge echogenic needle under sterile conditions prior to the start of surgery. No additional adjuvants will be administered. Standard perioperative analgesia will be provided to all participants.

Drug: Dexamethasone

Perineural Dexmedetomidine

ACTIVE COMPARATOR

Children in this arm will receive a single-shot popliteal sciatic nerve block performed under ultrasound guidance with 0.3 mL/kg of 0.2% ropivacaine combined with 0.5 µg/kg perineural dexmedetomidine (maximum dose per institutional pediatric guidelines). A 22-gauge echogenic needle will be used for block placement under sterile conditions. No additional adjuvants will be administered. Standard perioperative analgesia will be provided to all participants.

Drug: Dexmedetomidine

Perineural Dexamethasone + Dexmedetomidine Combination

ACTIVE COMPARATOR

Children in this arm will receive a single-shot popliteal sciatic nerve block performed under ultrasound guidance with 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg perineural dexamethasone and 0.5 µg/kg perineural dexmedetomidine (maximum doses per institutional pediatric guidelines). The block will be performed with a 22-gauge echogenic needle under sterile conditions before surgery. Standard perioperative analgesia will be provided to all participants.

Drug: Dexamethasone + Dexmedetomidine

Interventions

Dexamethasone DRUG

Perineural dexamethasone will be administered as an adjuvant to a single-shot popliteal sciatic nerve block. Children will receive 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg dexamethasone, injected under ultrasound guidance using a 22-gauge echogenic needle prior to surgery. The medication will be given as a single perineural dose only. Standard perioperative analgesia will be provided to all participants.

Perineural Dexamethasone

Dexmedetomidine DRUG

Perineural dexmedetomidine will be administered as an adjuvant to a single-shot popliteal sciatic nerve block. Children will receive 0.3 mL/kg of 0.2% ropivacaine combined with 0.5 µg/kg dexmedetomidine, injected under ultrasound guidance with a 22-gauge echogenic needle prior to surgery. The medication will be administered as a single perineural bolus. Standard perioperative analgesia will be provided to all participants.

Perineural Dexmedetomidine

Dexamethasone + Dexmedetomidine DRUG

Children in this arm will receive a combination of two perineural adjuvants added to a single-shot popliteal sciatic nerve block. The block will include 0.3 mL/kg of 0.2% ropivacaine combined with 0.1 mg/kg dexamethasone and 0.5 µg/kg dexmedetomidine, administered under ultrasound guidance using a 22-gauge echogenic needle prior to surgery. Both medications will be delivered together as a single perineural bolus. Standard perioperative analgesia will be provided to all participants.

Perineural Dexamethasone + Dexmedetomidine Combination

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3 to 12 years.
• Scheduled for elective unilateral lower limb surgery (foot, ankle, or distal lower leg) under general anesthesia with a popliteal sciatic nerve block planned for postoperative analgesia.
• ASA physical status I-III.
• Ability of parents or legal guardians to understand the study procedures and provide written informed consent.
• Child and parents/guardians available for telephone follow-up at 1 week and 1 month after surgery.

You may not qualify if:

• Refusal of the parents/legal guardians to provide informed consent or refusal of the child to cooperate with anesthesia or study procedures.
• Known allergy or hypersensitivity to ropivacaine, dexamethasone, dexmedetomidine, or any component of the study medications.
• Pre-existing neurological deficit or neuromuscular disease affecting the lower limbs (motor or sensory).
• Coagulopathy or current therapeutic anticoagulation that contraindicates regional anesthesia.
• Local infection, inflammation, or skin lesions at the planned block site.
• Severe cardiac, hepatic, renal, or respiratory disease that, in the investigator's opinion, increases the risk of study participation.
• History of clinically significant arrhythmias, severe bradycardia, or second/third degree atrioventricular block not treated with a pacemaker.
• Developmental delay or severe cognitive impairment that precludes reliable pain assessment or follow-up.
• Chronic use of opioid analgesics or sedatives (≥ 2 weeks of daily use before surgery).
• Participation in another interventional clinical trial within the last 30 days.
• Any other condition considered by the investigator to interfere with protocol adherence, safety monitoring, or reliable outcome assessment.

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences

Poznan, 62-701, Poland

RECRUITING

MeSH Terms

Conditions

Foot Diseases

Interventions

Dexamethasone; Dexmedetomidine

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• MAlgorzata Reysenr, MD PhD

  Poznań University of Medicla Sciences

  STUDY CHAIR

Central Study Contacts

Malgorzata Reysner, MD PhD

CONTACT

+48 61 873 83 03; mreysner@ump.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 17, 2025
• Study Start: January 16, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual participant data and supporting documents will become available 12 months after publication of the primary results and will remain available for 5 years.
• Access Criteria: Researchers must submit a methodologically sound proposal describing the planned use of the data. Requests will be reviewed by the study's principal investigators. Data will be shared only after signing a data access agreement and will be transferred using secure, password-protected methods.

Locations

PL (1)