Dexmedetomidine Vs Dexamethasone in Popliteal Nerve Block

Perineural Dexmedetomidine Vs Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery

Effect of Perineural Dexmedetomidine vs. Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery.

Study Overview

• Status: Recruiting
• Conditions: Foot Diseases; Ankle Disease; Ankle Injuries and Disorders; Foot Injury
• Intervention / Treatment: Drug: 0.1mg/kg Dexamethasone; Drug: 0.9% Sodium chloride; Drug: 0.05ug/kg Dexmedetomidine

Detailed Description

This study is proposed to explore the effect of systemic Dexamethasone on the duration of popliteal block for analgesia after pediatric ankle surgery.

After ankle/foot surgery, children need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.

The safety of local anaesthesia is essential in children due to the much lower toxicity threshold of local anaesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect.

There is considerable research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a massive lack of research regarding children.

In this study, investigators compare perineural Dexmedetomidine and Dexamethasone. Group 2 will have Dexamethasone in a 0.1mg/kg dose, and group 2 will have dexmedetomidine in a 0.5 ug/kg dose added to the local anaesthetic in peripheral nerve block.

The investigator's goal is to find which perineural adjuvant, Dexamethasone or dexmedetomidine, covers the need for good pain relief and fast recovery postoperatively.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Malgorzata Domagalska, PhD; Phone Number: 608762068; Email: m.domagalska@icloud.com
• Study Contact Backup: Name: Malgorzata Domalska, PhD; Phone Number: 608762068

Study Locations

• Poland
  • Wielkopolska
    • Poznań, Wielkopolska, Poland, 61-545
      • Recruiting
      • Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
      • Contact: Tomasz Kotwicki, Profesor; Phone Number: +48618310157; Email: kckod@ump.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• children scheduled for foot/ankle surgery
• body weight > 5kg

Exclusion Criteria:

• infection at the site of the regional blockade
• coagulation disorders
• immunodeficiency
• ASA= or >4
• steroid medication in regular use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sham Block; 0.2% ropivacaine for popliteal nerve block	Drug: 0.9% Sodium chloride; administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the popliteal nerve block; Other Names: placebo
Active Comparator: Dexamethasone; 0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block	Drug: 0.1mg/kg Dexamethasone; administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block
Active Comparator: Dexmedetomidine; 0.5ug/kg dexmedetomidine added to 0.2% ropivacaine for popliteal nerve block	Drug: 0.05ug/kg Dexmedetomidine; administration of 0.5ml/kg of 0.2% ropivacaine with 0.05ug/kg dexmedetomidine for the popliteal nerve block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to the first need of opiate following the procedure	Time after surgery when the patient needs opiate for the first time	within 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale	The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	4 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale	The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	6 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale	The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	8 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale	The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	12 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale	The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	16 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale	The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	20 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale	The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	24 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale	The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	36 hours
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Scale	The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain in individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.	48 hours
Neutrophil-to-lymphocyte ratio	Neutrophil to lymphocyte ratio (NLR) is used as a marker of subclinical inflammation. It is calculated by dividing the number of neutrophils by number of lymphocytes, usually from peripheral blood sample.	24 hours after surgery
Platelet-to-lymphocyte ratio	The platelet-lymphocyte ratio (PLR) is a novel inflammatory marker, which may be used in many diseases for predicting inflammation and mortality. The PLR can be easily calculated and is widely available but it may be affected by several inflammatory conditions.	48 hours after surgery
Platelet-to-lymphocyte ratio	The platelet-lymphocyte ratio (PLR) is a novel inflammatory marker, which may be used in many diseases for predicting inflammation and mortality. The PLR can be easily calculated and is widely available but it may be affected by several inflammatory conditions.	24 hours after surgery
Time to mobilization	Time after surgery when the patient moves the toe for the first time	within 48 hours

Collaborators and Investigators

• Sponsor: Poznan University of Medical Sciences
• Investigators: Study Chair: Tomasz Kotwicki, Prof dr hab, Poznan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Leg Injuries; Skin Diseases; Ankle Injuries; Wounds and Injuries; Foot Diseases; Foot Injuries; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexamethasone; Dexmedetomidine
• Other Study ID Numbers: 18/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No