A Comparative Study Between Age-Based and Weight-Based Bupivacaine Dosing for Pediatric Spinal Anesthesia in Children Undergoing Elective Infra-Umbilical Surgeries

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorCairo University

About this trial

This prospective randomized double-blinded controlled trial will include 60 pediatric patients aged 1 - 6 years old, both sexes, with American society of anesthesiologists (I and II) and undergoing elective infra-umbilical surgeries with anticipated duration ≤ 90 minutes. Patients will be randomly divided into two equal groups: Weight-based dosing (Group A) and age-based dosing group (Group B). Both groups will receive hyperbaric bupivacaine 0.5%. The aim of the study is to evaluate the effectiveness of using age based dosing of Bupivacaine compared with standard method of weight based dosing in pediatric spinal anesthesia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged 1-6 years

Both genders.

American Society of Anesthesiologists (ASA) physical status I or II.

Elective infra-umbilical surgeries with anticipated duration ≤ 90 minutes.

Disqualifiers

Guardian refusal.

Children with significant congenital heart disease (e.g., septal defects requiring surgical intervention)

Children with neuromuscular disorders or high intracranial pressure.

Children with spinal deformities or morbid obesity (body mass index (BMI) above the 99th percentile).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Spinal Anesthesia with Bupivacaine

    Procedure/Surgery

    Group A (n=30) will receive spinal anesthesia according to the weight-based dosing calculation of bupivacaine.

  • Spinal Anesthesia with Bupivacaine

    Procedure/Surgery

    Group B (n=30) will receive spinal anesthesia according to the age-based dosing calculation of bupivacaine.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group A: weight-based formula groupActive comparator 1 intervention
Group B: Group B: Age-based formula groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The peak sensory level

The peak sensory level will be assessed 5 minutes after intrathecal bupivacaine injection, and evaluated by a firm skin pinch.

Time frame
Assessed 5 minutes after intrathecal bupivacaine injection, and evaluated by a firm skin pinch up to 30 minutes after subarachnoid block

Secondary outcomes

1

Time of completion of spinal block

Time in seconds to complete block administration starting at the time of application of Betadine on the site of lumbar puncture to the time at which the patient is placed on their back after administration of spinal anesthesia

Time frame
starts immediately at the time of application of Betadine on the site of lumbar puncture to the time at which the patient is placed on their back after immediately administering the spinal anesthesia
2

Duration of spinal block

Duration of block: the time in minutes from achieving peak sensory and motor level to the onset of pain or the movement of the legs.

Time frame
starts immediately after achieving a peak sensory and motor levels and eds immediately by the onset of perioperative pain or movement of legs
3

Postoperative pain score

Postoperative pain score will be recorded using the Face, Legs, Activity, Cry, and Consolability (FLACC) Scale at 2, 4, and 6 hours from block administration. The scale consists of five categories: Face, Legs, Activity, Cry, and Consolability, each of which is scored from 0 to 2. A score of 0 represents no pain or distress, while a score of 2 indicates significant discomfort or distress.

Time frame
Scale will be assessed postoperatively at 2 hours, 4 hours, and 6 hours from block administration.
4

The need for rescue analgesia in PACU

The need for rescue analgesia in PACU: IV Pethidine 1 mg/kg will be administered once for a pain score of 6 or higher using FLACC scale

Time frame
Postoperatively at 2 hours after spinal block and up to 1 hour postoperatively

Other outcomes

1

Systolic blood pressure (SBP)

SBP will be recorded at T0 (baseline values before administration of block), then upon administration of spinal anesthesia, then every 3 minutes for 15 minutes, then every 5 minutes for the duration of the surgery.

Time frame
Will be recorded at T0 (baseline values before administration of block), then upon administration of spinal anesthesia, then every 3 minutes for 15 minutes, then every 5 minutes for the duration of the surgery until the end of surgery.
2

Diastolic blood pressure (DBP)

DBP will be recorded at T0 (baseline values before administration of block), then upon administration of spinal anesthesia, then every 3 minutes for 15 minutes, then every 5 minutes for the duration of the surgery.

Time frame
Will be recorded at T0 (baseline values before administration of block), then upon administration of spinal anesthesia, then every 3 minutes for 15 minutes, then every 5 minutes for the duration of the surgery until the end of surgery.
3

Mean blood pressure (MBP)

MBP will be recorded at T0 (baseline values before administration of block), then upon administration of spinal anesthesia, then every 3 minutes for 15 minutes, then every 5 minutes for the duration of the surgery.

Time frame
Will be recorded at T0 (baseline values before administration of block), then upon administration of spinal anesthesia, then every 3 minutes for 15 minutes, then every 5 minutes for the duration of the surgery until the end of surgery.
4

The dose bupivacaine administered.

The dose in millilitres of bupivacaine administered in each group will be recorded.

Time frame
Before the administration of local anesthesia, the dose will be calculated according to the group until the preoperative administration of spinal block.

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