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NCT06304324 Clinical Trial

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
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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