A Phase 4 interventional study of Sodium Chloride 0.9% Inj and 0,1mg/kg Dexamethasone in Ankle Disease, Foot Deformities and Foot Diseases, sponsored by Poznan University of Medical Sciences. Completed at 2 sites in Poland. Open to participants aged 3 Months to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-18.
Sponsored by Poznan University of Medical Sciences · Phase 4, Interventional, and Treatment
Effect of systematic dexamethasone on the duration of popliteal nerve block after pediatric ankle/foot surgery
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.
50 studies on the registry are indexed under Foot Deformities; 13 are open to participants now.
This study's enrollment of 90 is above the median of 60 across 26 interventional studies indexed under Foot Deformities.
Browse Foot Deformities studies →Poznan University of Medical Sciences is the lead sponsor of 151 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
5ml of 0,9% sodium chloride - before the popliteal nerve block
Drug: Sodium Chloride 0.9% Inj
0,1mg/kg dexamethasone sodium phosphate - before the popliteal nerve block
Drug: 0,1mg/kg Dexamethasone
0,2mg/kg dexamethasone sodium phosphate - before the popliteal nerve block
Drug: 0,2mg/kg Dexamethasone
administration of 5ml 0,9% sodium chloride - 30 minutes before the popliteal nerve block
Also known as: Placebo
administration of 0,1mg/kg Dexamethasone - 30 minutes before the popliteal nerve block
Also known as: small dose
administration of 0,2mg/kg Dexamethasone - 30 minutes before the popliteal nerve block
Also known as: large dose
first need of opiate
Time after surgery when the patient needs opiate for the first time
Time frame: 48 hours
Opioid Consumption
Total opiate consumption after surgery
Time frame: 48 hours
Pain score
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
Blood glucose
Blood glucose every 24 hour during hospitalization
Time frame: 24 and 48 hours after surgery
NLR
Neutrophil-to-lymphocyte ratio
Time frame: 24 and 48 hours after surgery
PLR
Platelet-to-lymphocyte ratio
Time frame: 24 and 48 hours after surgery
Mobilisation
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
Plan to share: Yes
Supporting information: Study protocol
Ran from Oct 2023 to primary completion in Jun 2025, 20 months.
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Sodium Chloride
Poznan University of Medical Sciences →