Effect of Systematic Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
Primary Purpose
Ankle Disease, Foot Deformities, Foot Diseases
Status
Enrolling by invitation
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Sodium Chloride 0.9% Inj
0,1mg/kg Dexamethasone
0,2mg/kg Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Ankle Disease
Eligibility Criteria
Inclusion Criteria: children scheduled for ankle/foot 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
Sites / Locations
- Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
- Poznan Univesity of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
placebo injection
0,1mg/kg Dexamethasone
0,2mg/kg Dexamethasone
Arm Description
5ml of 0,9% sodium chloride - before the popliteal nerve block
0,1mg/kg dexamethasone sodium phosphate - before the popliteal nerve block
0,2mg/kg dexamethasone sodium phosphate - before the popliteal nerve block
Outcomes
Primary Outcome Measures
first need of opiate
Time after surgery when the patient needs opiate for the first time
Secondary Outcome Measures
Opioid Consumption
Total opiate consumption after surgery
Pain score
children <3years old FLACC score (Face, Legs, Activity, Cry, Consolability) children >3years old NRS (Numerical Rating Scale)
Blood glucose
Blood glucose every 24 hour during hospitalization
NLR
Neutrophil-to-lymphocyte ratio
PLR
Platelet-to-lymphocyte ratio
Mobilisation
Toe movement every 4 hours
Full Information
NCT ID
NCT05887765
First Posted
May 24, 2023
Last Updated
October 11, 2023
Sponsor
Poznan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05887765
Brief Title
Effect of Systematic Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
Official Title
Effect of Systematic Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 19, 2023 (Anticipated)
Primary Completion Date
July 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poznan University of Medical Sciences
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Effect of systematic dexamethasone on the duration of popliteal nerve block after pediatric ankle/foot surgery
Detailed Description
This study is proposed to explore the effect of systemic dexamethasone on the duration of popliteal nerve block for analgesia after pediatric ankle surgery.
After ankle or 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 anesthesia is particularly important in children due to the much lower toxicity threshold of local anesthetics. The use of an effective adjuvant, such as Dexamethasone, could allow for the use of a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.
There is multiple research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a huge lack of research regarding children.
In this study, investigators compare different doses of systemic dexamethasone. Before the anesthesia, the patients receive dexamethasone intravenously. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg, and 0.2mg/kg.
The investigator's goal is to find a dexamethasone dose that is as low as possible but at the same time covers the need for good pain relief and fast recovery postoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankle Disease, Foot Deformities, Foot Diseases, Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
placebo injection
Arm Type
Active Comparator
Arm Description
5ml of 0,9% sodium chloride - before the popliteal nerve block
Arm Title
0,1mg/kg Dexamethasone
Arm Type
Active Comparator
Arm Description
0,1mg/kg dexamethasone sodium phosphate - before the popliteal nerve block
Arm Title
0,2mg/kg Dexamethasone
Arm Type
Active Comparator
Arm Description
0,2mg/kg dexamethasone sodium phosphate - before the popliteal nerve block
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride 0.9% Inj
Other Intervention Name(s)
Placebo
Intervention Description
administration of 5ml 0,9% sodium chloride - 30 minutes before the popliteal nerve block
Intervention Type
Drug
Intervention Name(s)
0,1mg/kg Dexamethasone
Other Intervention Name(s)
small dose
Intervention Description
administration of 0,1mg/kg Dexamethasone - 30 minutes before the popliteal nerve block
Intervention Type
Drug
Intervention Name(s)
0,2mg/kg Dexamethasone
Other Intervention Name(s)
large dose
Intervention Description
administration of 0,2mg/kg Dexamethasone - 30 minutes before the popliteal nerve block
Primary Outcome Measure Information:
Title
first need of opiate
Description
Time after surgery when the patient needs opiate for the first time
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Opioid Consumption
Description
Total opiate consumption after surgery
Time Frame
48 hours
Title
Pain score
Description
children <3years old FLACC score (Face, Legs, Activity, Cry, Consolability) children >3years old NRS (Numerical Rating Scale)
Time Frame
4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery
Title
Blood glucose
Description
Blood glucose every 24 hour during hospitalization
Time Frame
24 and 48 hours after surgery
Title
NLR
Description
Neutrophil-to-lymphocyte ratio
Time Frame
24 and 48 hours after surgery
Title
PLR
Description
Platelet-to-lymphocyte ratio
Time Frame
24 and 48 hours after surgery
Title
Mobilisation
Description
Toe movement every 4 hours
Time Frame
4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
children scheduled for ankle/foot 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Kotwicki, Prof.dr hab.
Organizational Affiliation
Poznań University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
City
Poznań
State/Province
Wielkopolska
ZIP/Postal Code
61-545
Country
Poland
Facility Name
Poznan Univesity of Medical Sciences
City
Poznań
State/Province
Wielkopolska
ZIP/Postal Code
61-701
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Effect of Systematic Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
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