Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06801600

Age-Based and Weight-Based Bupivacaine Dosing for Pediatric Spinal Anesthesia for Elective Infra-Umbilical Surgeries

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Weight-based dosing

Drug

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

Age-based dosing

Drug

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.

Primary outcomes

  1. The peak sensory level

    Time frame: 5 mins after intrathecal bupivacaine injection

    The sensory level of subarachnoid block, tested by firm skin pinch.

Secondary outcomes

  1. Block level time

    Time frame: 10 minutes from intrathecal injection of local anesthetic

    Time from injection of local anesthetic intrathecally to achieving full motor and adequate sensory block

  2. Duration of the block

    Time frame: 120 minutes from intrathecal injection of local anesthetic

    Duration from intrathecal injection of local anesthetic till return of motor power of the lower limbs

  3. Postoperative pain score

    Time frame: 3 hours from intrathecal injection of local anesthetic

    Postoperative pain levels using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale

  4. Incidence of failed spinal blocks

    Time frame: 2 hours from attempting subarachnoid block application

    Percentage of failed spinal blocks requiring conversion to general anesthesia

Study contacts

Contact information is provided by the study sponsor or research team.

Kareem MA Nawwar, M.D.

CONTACT

[email protected]

+201003878369

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

A Comparative Study Between Age-Based and Weight-Based Bupivacaine Dosing for Pediatric Spinal Anesthesia in Children Undergoing Elective Infra-Umbilical Surgeries: A Randomized Double-Blinded Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 30, 2025
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.