Spinal AnesthesiaPhase 4NCT06801600
Age-Based and Weight-Based Bupivacaine Dosing for Pediatric Spinal Anesthesia for Elective Infra-Umbilical Surgeries
A Phase 4 study testing Weight-based dosing and Age-based dosing in people with Spinal Anesthesia and Local Anesthetic, run by Cairo University.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Spinal Anesthesia, Local Anesthetic, Bupivacaine
- What is being tested?
- Weight-based dosing and Age-based dosing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2025to 5 Jun 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I and II
- Both genders
- Elective infra-umbilical surgeries with anticipated duration ≤ 90 minutes.
Who cannot join
- 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.
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- Children with known allergy to bupivacaine.
- Surgeries requiring head down (Trendelenburg) or prone position.
- Unexpected prolongation of surgery > 90 minutes.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
Read more
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.
- Conditions
- Spinal Anesthesia, Local Anesthetic, Bupivacaine
- Being tested
- Weight-based dosing, Age-based dosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight-based dosingDrug
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 dosingDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Weight-based dosing | Active comparator | 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 Receives: Drug: Weight-based dosing |
| Age-based dosing group | Active comparator | 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. Receives: Drug: Age-based dosing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The peak sensory level
The sensory level of subarachnoid block, tested by firm skin pinch.
Measured: 5 mins after intrathecal bupivacaine injection
Secondary outcomes (4)
Block level time
Time from injection of local anesthetic intrathecally to achieving full motor and adequate sensory block
Measured: 10 minutes from intrathecal injection of local anesthetic
Duration of the block
Duration from intrathecal injection of local anesthetic till return of motor power of the lower limbs
Measured: 120 minutes from intrathecal injection of local anesthetic
Postoperative pain score
Postoperative pain levels using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale
Measured: 3 hours from intrathecal injection of local anesthetic
Incidence of failed spinal blocks
Percentage of failed spinal blocks requiring conversion to general anesthesia
Measured: 2 hours from attempting subarachnoid block application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start30 Jan 2025 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion5 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kareem Mohammed Assem Nawwar, Cairo University
- Investigators
- Manal M Elgohary, M.D., Study chair, Cairo UniversityHany M Elhady, M.D., Study director, Cairo UniversityKareem MA Nawwar, M.D., Study director, Cairo UniversityBassant A Heikal, M.B.B.Ch., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801600
- Sponsor's protocol ID
- MS-503-2024
- Status last verified
- Jan 2025
- First submitted
- 25 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06801600
- Acronym / sponsor ID
- MS-503-2024
- Conditions
- Spinal Anesthesia, Local Anesthetic, Bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Jan 2025 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 5 Jun 2025 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight-based dosing | Active comparator | Drug: Weight-based dosingHyperbaric 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 group | Active comparator | Drug: Age-based dosingHyperbaric 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. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I and II
- Both genders
- Elective infra-umbilical surgeries with anticipated duration ≤ 90 minutes.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight-based dosingHyperbaric 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 | Drug | Weight-based dosing |
| Age-based dosingHyperbaric 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. | Drug | Age-based dosing group |
Primary outcome
The peak sensory level
Time frame: 5 mins after intrathecal bupivacaine injection
The sensory level of subarachnoid block, tested by firm skin pinch.
4 secondary outcomes
Block level time
Time frame: 10 minutes from intrathecal injection of local anesthetic
Duration of the block
Time frame: 120 minutes from intrathecal injection of local anesthetic
Postoperative pain score
Time frame: 3 hours from intrathecal injection of local anesthetic
Incidence of failed spinal blocks
Time frame: 2 hours from attempting subarachnoid block application
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manal M Elgohary, M.D. study chair
Cairo University
Hany M Elhady, M.D. study director
Cairo University
Kareem MA Nawwar, M.D. study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Weight-based dosing and Age-based dosing in people with Spinal Anesthesia and Local Anesthetic, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kareem MA Nawwar, M.D. (+201003878369, drknawwar@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The peak sensory level (time frame: 5 mins after intrathecal bupivacaine injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.