Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
Study Details
Study Description
Brief Summary
Effect of Perineural Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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 perineural Dexamethasone. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg and 0.05mg/kg added to local anesthetic.
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: placebo 0.2% ropivacaine for popliteal nerve block |
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
Other Names:
|
| Active Comparator: 0.1mg/kg Dexamethasone 0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block |
Drug: 0.1mg/kg Dexamethasone
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block
Other Names:
|
| Active Comparator: 0,05mg/kg dexamethasone 0.05mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block |
Drug: 0.05mg/kg Dexamethasone
administration of 0.5ml/kg of 0.2% ropivacaine with 0.05mg/kg Dexamethasone for the popliteal nerve block
Other Names:
|
Outcome Measures
Primary Outcome Measures
- first need of opiate [48 hours]
Time after surgery when the patient needs opiate for the first time
Secondary Outcome Measures
- Opioid Consumption [48 hours]
Total opiate consumption after surgery
- Pain score [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)
- Blood glucose [24 and 48 hours after surgery]
Blood glucose every 24 hours during hospitalization
- NLR [24 and 48 hours after surgery]
Neutrophil-to-lymphocyte ratio
- PLR [24 and 48 hours after surgery]
Platelet-to-lymphocyte ratio
- Mobilisation [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]
Toe movement every 4 hours
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Poznan University of Medical Sciences
Investigators
- Study Director: Tomasz Kotwicki, Prof.dr hab., Poznan University of Medical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 13/2023