- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05887778
Dexamethasone in Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery
Effect of Systematic Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is proposed to explore the effect of systemic Dexamethasone on the duration of supraclavicular brachial plexus block for analgesia after pediatric ankle surgery.
After hand and wrist 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, 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 use has been compared in adults. However, there is a massive 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 simultaneously covers the need for good pain relief and fast recovery postoperatively.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Małgorzata Domagalska
- Phone Number: 608762068
- Email: m.domagalska@icloud.com
Study Locations
-
-
-
Poznań, Poland
- Recruiting
- Poznan University of Medical Sciences
-
Contact:
- MAłgorzata Domagalska, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- children scheduled for hand/wrist 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: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: placebo injection
5ml of 0,9% sodium chloride - before the popliteal nerve block
|
administration of 5ml 0,9% sodium chloride - 30 minutes before the supraclavicular brachial plexus block
Other Names:
|
Active Comparator: 0,1mg/kg Dexamethasone
0,1mg/kg dexamethasone sodium phosphate - before the popliteal nerve block
|
administration of 0,1mg/kg Dexamethasone - 30 minutes before the supraclavicular brachial plexus block
Other Names:
|
Active Comparator: 0,2 mg/kg Dexamethasone
0,2 mg/kg dexamethasone sodium phosphate - before the popliteal nerve block
|
administration of 0,2mg/kg Dexamethasone - 30 minutes before the supraclavicular brachial plexus block
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
first need of opiate
Time Frame: 48 hours
|
Time after surgery when the patient needs opiate for the first time
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Opioid Consumption
Time Frame: 48 hours
|
Total opiate consumption after surgery
|
48 hours
|
Pain score
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
|
children <3years old FLACC score (Face, Legs, Activity, Cry, Consolability) children >3years old NRS (Numerical Rating Scale)
|
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
|
Blood glucose
Time Frame: 24 and 48 hours after surgery
|
Blood glucose every 24 hour during hospitalization
|
24 and 48 hours after surgery
|
NLR
Time Frame: 24 and 48 hours after surgery
|
Neutrophil-to-lymphocyte ratio
|
24 and 48 hours after surgery
|
PLR
Time Frame: 24 and 48 hours after surgery
|
Platelet-to-lymphocyte ratio
|
24 and 48 hours after surgery
|
Mobilisation
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
|
Finger movement every 4 hours
|
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
|
Collaborators and Investigators
Investigators
- Study Director: Leszek Romanowski, Prof.dr hab, Poznan University of Medical Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Hand Injuries
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Dexamethasone
- Dexamethasone acetate
- BB 1101
Other Study ID Numbers
- 9/2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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