Perineural Dexamethasone in Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery

Hand Injuries Clinical Trial

Official title:

Effect of Perineural Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06086392
• Other study ID #: 12/2023
• Status: Recruiting
• Phase: Phase 4
• Start date: October 17, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: January 2024
• Source: Poznan University of Medical Sciences
• Contact: Malgorzata Domagalska, Ph.D.
• Phone: +48 608762068
• Email: m.domagalska[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effect of Perineural Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery

Description:

This study is proposed to explore the effect of perineurial Dexamethasone on the duration of supraclavicular brachial plexus block for analgesia after pediatric ankle surgery. After hand and wrist 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hand Injuries
• Hand Injuries and Disorders
• Wounds and Injuries
• Wrist Injuries

Intervention

Drug:
• Placebo
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the supraclavicular brachial plexus block
• 0.1mg/kg Dexamethasone
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the supraclavicular brachial plexus block
• 0.05mg/kg Dexamethasone
administration of 0.5ml/kg of 0,2% ropivacaine with 0.05mg/kg Dexamethasone for the supraclavicular brachial plexus block

Locations

Country	Name	City	State
Poland	Poznan University of Medical Sciences	Poznan	Poznan

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	Finger 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