Effect of Systematic Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery

Sponsor

Poznan University of Medical Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05887765

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Effect of systematic dexamethasone on the duration of popliteal nerve block after pediatric ankle/foot surgery

Condition or Disease	Intervention/Treatment	Phase
Ankle Disease Foot Deformities Foot Diseases Cerebral Palsy	Drug: Sodium Chloride 0.9% Inj Drug: 0,1mg/kg Dexamethasone Drug: 0,2mg/kg Dexamethasone	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Effect of Systematic Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: placebo injection 5ml of 0,9% sodium chloride - before the popliteal nerve block	Drug: Sodium Chloride 0.9% Inj administration of 5ml 0,9% sodium chloride - 30 minutes before the popliteal nerve block Other Names: Placebo
Active Comparator: 0,1mg/kg Dexamethasone 0,1mg/kg dexamethasone sodium phosphate - before the popliteal nerve block	Drug: 0,1mg/kg Dexamethasone administration of 0,1mg/kg Dexamethasone - 30 minutes before the popliteal nerve block Other Names: small dose
Active Comparator: 0,2mg/kg Dexamethasone 0,2mg/kg dexamethasone sodium phosphate - before the popliteal nerve block	Drug: 0,2mg/kg Dexamethasone administration of 0,2mg/kg Dexamethasone - 30 minutes before the popliteal nerve block Other Names: large dose

Arm

Intervention/Treatment

Active Comparator: placebo injection

5ml of 0,9% sodium chloride - before the popliteal nerve block

Drug: Sodium Chloride 0.9% Inj

administration of 5ml 0,9% sodium chloride - 30 minutes before the popliteal nerve block

Other Names:

Placebo

Active Comparator: 0,1mg/kg Dexamethasone

0,1mg/kg dexamethasone sodium phosphate - before the popliteal nerve block

Drug: 0,1mg/kg Dexamethasone

administration of 0,1mg/kg Dexamethasone - 30 minutes before the popliteal nerve block

Other Names:

small dose

Active Comparator: 0,2mg/kg Dexamethasone

0,2mg/kg dexamethasone sodium phosphate - before the popliteal nerve block

Drug: 0,2mg/kg Dexamethasone

administration of 0,2mg/kg Dexamethasone - 30 minutes before the popliteal nerve block

Other Names:

large dose

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 hour 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

Ages Eligible for Study:

3 Months to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland	Poznań	Wielkopolska	Poland	61-545
2	Poznan Univesity of Medical Sciences	Poznań	Wielkopolska	Poland	61-701