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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06086392
Other study ID # 12/2023
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


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
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