Clinical trial NCT05887765: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankle Disease
Foot Deformities
Foot Diseases
Cerebral Palsy
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: first need of opiate
timeFrame: 48 hours
Secondary outcomes:
measure: Opioid Consumption
timeFrame: 48 hours
measure: Pain score
timeFrame: 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
measure: Blood glucose
timeFrame: 24 and 48 hours after surgery
measure: NLR
timeFrame: 24 and 48 hours after surgery
measure: PLR
timeFrame: 24 and 48 hours after surgery
measure: Mobilisation
timeFrame: 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
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
state: Wielkopolska
city: Poznań
country: Poland
facility: Poznan Univesity of Medical Sciences
state: Wielkopolska
Study officials:
affiliation: Poznań University of Medical Sciences
name: Tomasz Kotwicki, Prof.dr hab.
role: STUDY_CHAIR
References: