Skip to main content
OpenTrials
Completed

NCT Number: NCT05117281

Comparison of Postoperative Analgesic Efficacy of Caudal Block Versus Spinal Block With Levobupivacaine for Inguinal Hernia in Children

Neuraxial analgesia may improve postoperative outcomes for high-risk children who are susceptible to respiratory complications (e.g. post-operative apnea). The use of spinal anesthesia in infants and children requiring surgeries of the sub-umbilical regions is gaining considerable popularity worldwide. Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Bupivacaine has been thoroughly studied, and a large global experience exists.

Completed

Looking for future studies?

Notify Me

Key information

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut governorate

Asyut, 715715, Egypt

About this study

Neuraxial analgesia may improve postoperative outcomes for high-risk children who are susceptible to respiratory complications (post-operative apnea). In this population, spinal anesthesia has been proposed as a means to reduce post-operative complications, especially apnea and post-operative respiratory dysfunction, although this utility has been questioned.

Spinal anesthesia modifies the neuroendocrine stress response, ensures a more rapid recovery, and may shorten hospital stay with fewer opioid-induced side effects.

Caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. Caudal anesthetics usually provide an-algesia for approximately 4-6 hours.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: 2-10 years.
  • Weight: 15-40 kg.
  • Sex: both males and females.
  • ASA physical status: 1-II.
  • Operation: surgery below the umbilicus.

Exclusion criteria

  • Allergic reaction to local anesthetics (LAs).
  • Local or systemic infection (risk of meningitis).
  • Intracranial hypertension.
  • Hydrocephalus.
  • Intracranial hemorrhage.
  • Coagulopathy.
  • Hypovolemia.
  • Parental refusal.
  • Spinal deformities, such as spina bifida or myelomeningocele.
  • Presence of a ventriculoperitoneal shunt because of a risk of shunt infection or dural leak.

Treatment and study plan

Levobupivacaine

Drug

Plain, isobaric levobupivacaine (0.25%) 1 ml/kg

Other names: Levobupivacaine hydrate

Primary outcomes

  1. FLACC scale FLACC scores will be recorded. FLACC scores will be recorded. FLACC score will be recorded

    Time frame: 24 hours postoperative

    Face, Legs, Activity, Cry, Consolability scale will be recorded. Each category is scored on the 0 to 2 scale. Add the scores together (for a total possible score of 0 to 10).

Secondary outcomes

  1. Total consumption of rescue analgesics

    Time frame: 24 hours

    mg/24

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Comparison of Postoperative Analgesic Efficacy of Caudal Block Versus Spinal Block With Levobupivacaine for Inguinal Hernia in Children: A Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Nov 11, 2021
Registry last updated
Dec 2, 2021

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.