Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery
Primary Purpose
Scoliosis Idiopathic, Scoliosis; Adolescence
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
0.9% sodium chloride
Dexamethasone
Dexmedetomidine
Sponsored by
About this trial
This is an interventional treatment trial for Scoliosis Idiopathic
Eligibility Criteria
Inclusion Criteria: children scheduled for idiopathic scoliosis surgery age >10 and <18 years Exclusion Criteria: age < 10 years age < 18 years infection at the site of the regional blockade coagulation disorders immunodeficiency ASA= or >4 steroid medication in regular use
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
Dexamethasone
Dexmedetomidine
Arm Description
0.2% ropivacaine for erector spinae plane block
0.2% ropivacaine + 0.1mg/kg Dexamethasone for erector spinae plane block
0.2% ropivacaine + 0.1ug/kg Dexmedetomidine for erector spinal plane 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
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Numerical Rating Scale [range 0:10]
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
NLR
Neutrophil-to-lymphocyte ratio
PLR
Platelet-to-lymphocyte ratio
Full Information
NCT ID
NCT06086431
First Posted
October 11, 2023
Last Updated
October 11, 2023
Sponsor
Poznan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT06086431
Brief Title
Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery
Official Title
Dexamethasone vs. Dexmedetomidine for Erector Spine Plane Block in Pain Management After Pediatric Idiopathic Scoliosis Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
December 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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.
Detailed Description
This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.
After scoliosis 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 essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone or Dexmedetomidine, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.
There is considerable research where intravenous and perineural dexamethasone and Dexmedetomidine use has been compared in adults. However, there is a massive lack of research regarding children.
In this study, investigators compare perineural Dexamethasone and Dexmedetomidine. Group 2 has dexamethasone doses of 0.1mg/kg, and group 3 has 0,1ug/kg Dexmedetomidine added to the local anesthetic.
The investigator aims to find a dexamethasone or dexmedetomidine that 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
Scoliosis Idiopathic, Scoliosis; Adolescence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.2% ropivacaine for erector spinae plane block
Arm Title
Dexamethasone
Arm Type
Active Comparator
Arm Description
0.2% ropivacaine + 0.1mg/kg Dexamethasone for erector spinae plane block
Arm Title
Dexmedetomidine
Arm Type
Active Comparator
Arm Description
0.2% ropivacaine + 0.1ug/kg Dexmedetomidine for erector spinal plane block
Intervention Type
Drug
Intervention Name(s)
0.9% sodium chloride
Other Intervention Name(s)
placebo
Intervention Description
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the erector spine plane block
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the erector spine plane block
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Intervention Description
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1ug/kg Dexmedetomidine for the erector spine plane 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
Numerical Rating Scale [range 0:10]
Description
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time Frame
4 hours after surgery
Title
Numerical Rating Scale [range 0:10]
Description
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time Frame
8 hours after surgery
Title
Numerical Rating Scale [range 0:10]
Description
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time Frame
12 hours after surgery
Title
Numerical Rating Scale [range 0:10]
Description
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time Frame
16 hours after surgery
Title
Numerical Rating Scale [range 0:10]
Description
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time Frame
20 hours after surgery
Title
Numerical Rating Scale [range 0:10]
Description
NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever)
Time Frame
24 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]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children scheduled for idiopathic scoliosis surgery
age >10 and <18 years
Exclusion Criteria:
age < 10 years
age < 18 years
infection at the site of the regional blockade
coagulation disorders
immunodeficiency
ASA= or >4
steroid medication in regular use
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Małgorzata Domagalska, Ph.D.
Phone
+48 608762068
Email
m.domagalska@icloud.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Kotwicki, Prof.dr hab.
Organizational Affiliation
Poznan University of Medical Sciences
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Dexamethasone vs. Dexmedetomidine for ESPB in Pain Management After Pediatric Idiopathic Scoliosis Surgery
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