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

NCT07035184 | Not Yet Recruiting

• 1 other identifier: "MS-503-2024"
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pediatrics; Spinal Aneshtesia; Infraumbilical Surgeries

Outcome Measures

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.

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

Secondary Outcomes (7)

• Time of completion of spinal block

  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

• Duration of spinal block

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

• Postoperative pain score

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

• The need for rescue analgesia in PACU

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

• Incidence of failure of spinal block

  20 minutes after local anesthetic administration until 30 minutes after local anesthetic administration

Other Outcomes (10)

• Systolic blood pressure (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 until the end of surgery.

• Diastolic blood pressure (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 until the end of surgery.

• Mean blood pressure (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 until the end of surgery.

Study Arms (2)

Group A: weight-based formula group

ACTIVE COMPARATOR

Children will receive spinal anesthesia according to the weight-based dosing calculation of Hyperbaric bupivacaine 0.5% as following: 0.4 mg/kg (0.08 ml/kg) for children weighing 5-15 kg or 0.3 mg/kg (0.06 ml/kg) for children weighing \>15 kg

Procedure: Spinal Anesthesia with Bupivacaine

Group B: Age-based formula group

ACTIVE COMPARATOR

Children will receive spinal anesthesia according to the age-based dosing calculation of bupivacaine. Hyperbaric bupivacaine 0.5% will be calculated using Partha formula by dividing the child's age in years by 5. The resultant figure will be considered to be the dose of Bupivacaine in ml. If the number of months after the completion of a year in age is more than 6 months, the child's age will be noted to be the year older.

Procedure: Spinal Anesthesia with Bupivacaine

Interventions

Spinal Anesthesia with Bupivacaine PROCEDURE

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

Group A: weight-based formula group

Eligibility Criteria

• Age: 1 Year - 6 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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 Trendelenburg or prone position.
• Unexpected prolongation of surgery \> 90 minutes

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Abu Elreesh Pediatric Hospital

Cairo, Assida Zainab, 12211, Egypt

Location

Related Publications (12)

• Crellin DJ, Harrison D, Santamaria N, Huque H, Babl FE. The Psychometric Properties of the FLACC Scale Used to Assess Procedural Pain. J Pain. 2018 Aug;19(8):862-872. doi: 10.1016/j.jpain.2018.02.013. Epub 2018 Mar 15.

  PMID: 29551662 BACKGROUND

• Srinivasan P, Saravanan B, Kulandayan I, Thambidurai S, Mahalakshmi V. Evaluation of efficacy and safety of age-based intrathecal dosing of 0.5% hyperbaric bupivacaine in the paediatric age group. J Clin Diagn Res. 2020;14(8):29-31.

  BACKGROUND

• Troncin R, Dadure C. Paediatric spinal anaesthesia. management. 2009;4(3):8-12.

  BACKGROUND

• Elsharkawi NG. Simple pediatric analog sedation score (PASS). Anesth Analg. 1999 Jan;88(1):227. doi: 10.1097/00000539-199901000-00043. No abstract available.

  PMID: 9895098 BACKGROUND

• Luca E, Schipa C, Cambise C, Sollazzi L, Aceto P. Implication of age-related changes on anesthesia management. Saudi J Anaesth. 2023 Oct-Dec;17(4):474-481. doi: 10.4103/sja.sja_579_23. Epub 2023 Aug 18.

  PMID: 37779561 BACKGROUND

• Hebbes CP, Thompson JP. Pharmacokinetics of anaesthetic drugs at extremes of body weight. BJA Educ. 2018 Dec;18(12):364-370. doi: 10.1016/j.bjae.2018.09.001. Epub 2018 Oct 26. No abstract available.

  PMID: 33456803 BACKGROUND

• Visavakul O, Leurcharusmee P, Pipanmekaporn T, Khorana J, Patumanond J, Phinyo P. Effective Dose Range of Intrathecal Isobaric Bupivacaine to Achieve T5-T10 Sensory Block Heights for Elderly and Overweight Patients: An Observational Study. Medicina (Kaunas). 2023 Mar 1;59(3):484. doi: 10.3390/medicina59030484.

  PMID: 36984485 BACKGROUND

• Parthasarathy S, Senthilkumar T. Age-based Local Anesthetic Dosing in Pediatric Spinal Anesthesia: Evaluation of a New Formula - A Pilot Study in Indian Patients. Anesth Essays Res. 2017 Jul-Sep;11(3):627-629. doi: 10.4103/aer.AER_246_16.

  PMID: 28928560 BACKGROUND

• Lonnqvist PA. Spinal anaesthesia in children: A narrative review. Best Pract Res Clin Anaesthesiol. 2023 Jun;37(2):133-138. doi: 10.1016/j.bpa.2023.01.002. Epub 2023 Feb 7.

  PMID: 37321762 BACKGROUND

• Jefferson FA, Findlay BL, Handlogten KS, Gargollo PC, Warner LL, Woodbury JM, Haile DT, Granberg CF. Spinal anesthesia in infants undergoing urologic surgery duration greater than 60 minutes. J Pediatr Urol. 2022 Dec;18(6):786.e1-786.e7. doi: 10.1016/j.jpurol.2022.07.003. Epub 2022 Jul 14.

  PMID: 35945145 BACKGROUND

• Verma D, Naithani U, Gokula C, Harsha. Spinal anesthesia in infants and children: A one year prospective audit. Anesth Essays Res. 2014 Sep-Dec;8(3):324-9. doi: 10.4103/0259-1162.143124.

  PMID: 25886329 BACKGROUND

• Heydinger G, Tobias J, Veneziano G. Fundamentals and innovations in regional anaesthesia for infants and children. Anaesthesia. 2021 Jan;76 Suppl 1:74-88. doi: 10.1111/anae.15283.

  PMID: 33426659 BACKGROUND

MeSH Terms

Interventions

Anesthesia, Spinal; Bupivacaine

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Hany M.EH Mohammed, MD

CONTACT

+201003066806; oblfollower_2001@yahoo.com, hany.elhadi@kasralainy.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 7, 2025
• First Posted: June 25, 2025
• Study Start: August 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 15, 2025
• Last Updated: June 25, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)