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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06233565
Other study ID # 1/2024
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date February 9, 2024
Est. completion date November 30, 2024

Study information

Verified date April 2024
Source Poznan University of Medical Sciences
Contact Malgorzata Domagalska, MD PhD
Phone +48608762068
Email m.domagalska@icloud.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Effect of perineurial dexamethasone and dexmedetomidine on popliteal nerve block duration for pediatric, ankle or foot surgery


Description:

This study is proposed to explore the effect of perineurial Dexamethasone and Dexmedetomidine on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery. After scoliosis 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 or Dexmedetomidine, 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 and Dexmedetomidine use has been compared in adults. However, there is a massive lack of research regarding children. In this study, investigators compare perineural Dexamethasone and Dexmedetomidine. Group 2 has dexamethasone doses of 0.1mg/kg, and group 3 has 0,1ug/kg Dexmedetomidine added to the local anesthetic. The investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date November 30, 2024
Est. primary completion date August 30, 2024
Accepts healthy volunteers No
Gender All
Age group 3 Months to 7 Years
Eligibility Inclusion Criteria: - all children scheduled for ankle or foot surgery - aged > 3 months < 7 years Exclusion Criteria: - age < 3 months - age > 7 years - infection at the site of the regional blockade - coagulation disorders - immunodeficiency - ASA= or >4 - steroid medication in regular use - chronic pain

Study Design


Intervention

Drug:
0.9%sodium chloride
administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the popliteal nerve block
Dexamethasone
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block
Dexmedetomidine
administration of 0.5ml/kg of 0.2% ropivacaine with 0.1ug/kg Dexmedetomidine for 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 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 Numerical Rating Scale [range 0:10] NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) [Time Frame: 4 hours after surgery]
Secondary Numerical Rating Scale [range 0:10] NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) [Time Frame: 6 hours after surgery]
Secondary Numerical Rating Scale [range 0:10] NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) [Time Frame: 8 hours after surgery]
Secondary Numerical Rating Scale [range 0:10] NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) [Time Frame: 12 hours after surgery]
Secondary Numerical Rating Scale [range 0:10] NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) [Time Frame: 24 hours after surgery]
Secondary Numerical Rating Scale [range 0:10] NRS (Numerical Rating Scale; 0 - no pain; 10 - the worst pain ever) [Time Frame: 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
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