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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05887765
• Other study ID #: 8/2023
• Status: Completed
• Phase: Phase 4
• Start date: October 17, 2023
• Est. completion date: February 23, 2024

Study information

• Verified date: February 2024
• Source: Poznan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 23, 2024
• Est. primary completion date: February 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Ankle Disease
• Cerebral Palsy
• Foot Deformities
• Foot Diseases

Intervention

Drug:
• Sodium Chloride 0.9% Inj
administration of 5ml 0,9% sodium chloride - 30 minutes before the popliteal nerve block
• 0,1mg/kg Dexamethasone
administration of 0,1mg/kg Dexamethasone - 30 minutes before the popliteal nerve block
• 0,2mg/kg Dexamethasone
administration of 0,2mg/kg Dexamethasone - 30 minutes before the popliteal nerve block

Locations

Country	Name	City	State
Poland	Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznan, Poland	Poznan	Wielkopolska
Poland	Poznan Univesity of Medical Sciences	Poznan	Wielkopolska

Sponsors (1)

Lead Sponsor	Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	first need of opiate	Time after surgery when the patient needs opiate for the first time	48 hours
Secondary	Opioid Consumption	Total opiate consumption after surgery	48 hours
Secondary	Pain score	children <3years old FLACC score (Face, Legs, Activity, Cry, Consolability) children >3years old NRS (Numerical Rating Scale)	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
Secondary	Blood glucose	Blood glucose every 24 hour during hospitalization	24 and 48 hours after surgery
Secondary	NLR	Neutrophil-to-lymphocyte ratio	24 and 48 hours after surgery
Secondary	PLR	Platelet-to-lymphocyte ratio	24 and 48 hours after surgery
Secondary	Mobilisation	Toe movement every 4 hours	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