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

A

Assiut University

Status

Completed

Conditions

Pain, Postoperative
Analgesia

Treatments

Drug: Levobupivacaine

Study type

Interventional

Funder types

Other

Identifiers

NCT05117281
17300727

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

2 to 10 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

spinal group
Active Comparator group
Description:
Plain, isobaric levobupivacaine(0.25%) 0.25 mg/kg
Treatment:
Drug: Levobupivacaine
Drug: Levobupivacaine
caudal group
Active Comparator group
Description:
Plain, isobaric levobupivacaine (0.25%) 1 ml/kg
Treatment:
Drug: Levobupivacaine
Drug: Levobupivacaine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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