Postoperative Pain, Caudal Anesthesia, Peripheral Perfusion, Pediatric Surgery
Conditions
Keywords
Dexmedetomidine, Perfusion Index, Caudal Block, Levobupivacaine, Hemodynamics, Infraumbilical Surgery, Pediatric Anesthesia, Postoperative Analgesia
Brief summary
Caudal anesthesia is widely used to provide pain relief for children undergoing surgery below the navel (infraumbilical surgery). Dexmedetomidine is a medication commonly added to local anesthetics to enhance pain control and reduce stress responses during surgery. It can be given directly into the caudal space or through an intravenous (IV) line into the bloodstream, but it remains unclear which route provides better blood flow regulation and vital sign stability. This study aims to compare the effects of caudal versus intravenous dexmedetomidine on peripheral blood flow, measured non-invasively using the Perfusion Index (PI), as well as heart rate and blood pressure in pediatric patients. A total of 100 children aged 1 to 7 years undergoing elective infraumbilical surgery will be randomly assigned to one of two groups: * Group C (Caudal Group): Receives dexmedetomidine added to the caudal local anesthetic (levobupivacaine) alongside an IV saline placebo infusion. * Group I (Intravenous Group): Receives the caudal local anesthetic alone alongside an IV infusion containing dexmedetomidine. Neither the parents nor the healthcare team will know which study drug regimen the child receives. Investigators will record changes in the Perfusion Index, monitor heart rate and blood pressure throughout surgery and recovery, and evaluate postoperative pain scores and recovery room discharge times.
Interventions
Dexmedetomidine (1 µg/kg) combined with 0.25% levobupivacaine (total volume 1 mL/kg) administered into the caudal epidural space over 60 seconds under general anesthesia, along with a concurrent 10-minute IV placebo infusion of 20 mL normal saline.
Dexmedetomidine (1 µg/kg) diluted in 20 mL normal saline administered as an intravenous infusion over 10 minutes, along with a concurrent caudal injection of 0.25% levobupivacaine (1 mL/kg) administered over 60 seconds under general anesthesia.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients aged 1 to 7 years. * American Society of Anesthesiologists (ASA) physical status I or II. * Scheduled for elective infraumbilical surgery. * Anticipated duration of surgery less than 120 minutes. * Written informed consent obtained from parents or legal guardians.
Exclusion criteria
* Coagulopathy or bleeding disorders. * Pre-existing local infection at the caudal injection site. * Known congenital heart disease. * Neurological or neuromuscular disorders. * Known allergy or hypersensitivity to dexmedetomidine, local anesthetics, or any study medication. * Significant developmental delay affecting pain assessment. * Failed caudal block. * Parental or guardian refusal to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peak Increase in Perfusion Index | Up to 4 hours | Perfusion index (PI) is monitored continuously using a pulse oximeter probe placed on the middle finger of the right hand. PI reflects the ratio of pulsatile to non-pulsatile infrared light absorption (AC/DC x 100). Baseline PI is calculated as the mean of three consecutive stable readings obtained prior to caudal block placement. The primary outcome is the maximum increase in PI from baseline (peak PI minus baseline PI) observed during surgery and the recovery stay. |
Outcome results
None listed