Dexmedetomidine vs Dexamethasone in Popliteal Nerve Block

Foot Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06304324
• Other study ID #: 18/2023
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 1, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: January 2024
• Source: Poznan University of Medical Sciences
• Contact: Malgorzata Domagalska, PhD
• Phone: 608762068
• Email: m.domagalska[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: April 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Disease
• Ankle Injuries
• Ankle Injuries and Disorders
• Foot Diseases
• Foot Injuries
• Foot Injury
• Wounds and Injuries

Intervention

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
• 0.1mg/kg Dexamethasone
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block
• 0.05ug/kg Dexmedetomidine
administration of 0.5ml/kg of 0.2% ropivacaine with 0.05ug/kg dexmedetomidine for the popliteal nerve block

Locations

Country	Name	City	State
Poland	Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznan, Poland	Poznan	Wielkopolska

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time to mobilization	Time after surgery when the patient moves the toe for the first time	within 48 hours