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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05117281

Enrollment

Registered

2021-11-11

Start date

2021-09-10

Completion date

2021-10-15

Last updated

2021-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Pain, Postoperative

Brief summary

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.

Detailed description

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.

Interventions

DRUGLevobupivacaine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

2 Years to 10 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
FLACC scale FLACC scores will be recorded. FLACC scores will be recorded. FLACC score will be recorded	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

Measure	Time frame	Description
Total consumption of rescue analgesics	24 hours	mg/24

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026