Bupivacaine, Local Anesthetic, Spinal Anesthesia
Conditions
Brief summary
Pediatric anesthesia presents distinctive challenges, particularly concerning appropriate dosage administration of local anesthetics for spinal anesthesia (SA). Spinal anesthesia in infants has been linked to a lower incidence of hypotension, hypoxia, bradycardia, and postoperative apnea in comparison to general anesthesia (GA); ensuring a high level of cardiovascular and respiratory stability. Additionally, SA has been linked to lower operating room time, post-anesthesia care unit, hospital length of stay, corticosteroid administration, narcotic requirements, postoperative emesis, and cardiopulmonary complications in comparison to GA. A reduction in systemic blood pressure frequently accompanies neuraxial blocks in adults, necessitating intervention. Nevertheless, spinal, caudal, or epidural blocks administered to children under six years old are not associated with any substantial alterations in blood pressure. In children aged 6 to 10, there is a linear decrease in blood pressure that will reach a plateau at approximately a 30% decrease in those beyond the age of 10. Conversely, younger children require no additional precautions. Bupivacaine, has a narrow therapeutic index in children, and its dosing requires careful consideration to strike a balance between effective anesthesia and the risk of toxicity. The traditional method of dosing bupivacaine in pediatric spinal anesthesia is based on the child's body weight. This weight-based dosing considers the assumption that children's drug clearance correlates with their body mass. However, this approach might not account for the maturational changes in drug handling by pediatric patients or the variability in spinal column length and cerebrospinal fluid volumes, not always proportional to weight but may evolve with age. Emerging evidence suggests that age-based dosing may be more effective. It hypothesizes that developmental pharmacokinetics, including changes in body composition, organ function, and drug-receptor differences, can influence bupivacaine metabolism and action more significantly than body mass alone. By accounting for the age-related anatomical and physiological changes, age-based dosing could result in more precise and effective anesthesia with a decreased risk of adverse outcomes. To the authors knowledge, there is no study comparing age-based and weight-based bupivacaine dosing for pediatric spinal anesthesia in children undergoing elective infra-umbilical surgery.
Interventions
DRUGWeight-based dosing
Hyperbaric bupivacaine 0.5% dosage will be calculated and administered intrathecally as 0.4 mg/kg or 0.08 ml/kg if body weight ≤ 15 kg and 0.3 mg/kg or 0.06 ml/kg if body weight \> 15 kg
DRUGAge-based dosing
Hyperbaric bupivacaine 0.5% will be administered at the dose of age divided by 5 (in ml). The age in months after the completion of a year was noted and considered as the next age if it is more than 6 months and the same age if it is ≤ 6 months.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* ASA I and II * Both genders * Elective infra-umbilical surgeries with anticipated duration ≤ 90 minutes.
Exclusion criteria
* Guardian refusal. * Children with major congenital heart disease, including septal defects. * Patients with neuromuscular disorders or high intracranial pressure. * Children with spinal deformities or morbid obesity (BMI above the 99th percentile). * Children with a history or family history of coagulation disorders. * Children with local infection at the site of skin puncture for spinal anesthesia. * Children with known allergy to bupivacaine. * Surgeries requiring head down (Trendelenburg) or prone position. * Unexpected prolongation of surgery \> 90 minutes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The peak sensory level | 5 mins after intrathecal bupivacaine injection | The sensory level of subarachnoid block, tested by firm skin pinch. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Block level time | 10 minutes from intrathecal injection of local anesthetic | Time from injection of local anesthetic intrathecally to achieving full motor and adequate sensory block |
| Duration of the block | 120 minutes from intrathecal injection of local anesthetic | Duration from intrathecal injection of local anesthetic till return of motor power of the lower limbs |
| Postoperative pain score | 3 hours from intrathecal injection of local anesthetic | Postoperative pain levels using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale |
| Incidence of failed spinal blocks | 2 hours from attempting subarachnoid block application | Percentage of failed spinal blocks requiring conversion to general anesthesia |
Contacts
Primary ContactKareem MA Nawwar, M.D.
Outcome results
None listed