Clinical trial NCT06086418: Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
Official title: Effect of Perineural 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
Ankle Injuries
Foot Injury
Foot Diseases
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of Perineural Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery.

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 foot and ankle 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.

Eligibility 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

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: Poznan
country: Poland
facility: Poznan University of Medical Sciences
state: Poznań
Study officials:
affiliation: Poznan University of Medical Sciences
name: Tomasz Kotwicki, Prof.dr hab.
role: STUDY_DIRECTOR
References: