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

Not Applicable

Completed

• Conditions: Pain, Postoperative; Analgesia
• Interventions: Drug: Levobupivacaine

• Registration Number: NCT05117281
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2021-09-10
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-15
• Status Verified: 2021-11
• Study First Submitted: 2021-11-01
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-11
• Last Update Submitted: 2021-11-22
• Last Update Posted: 2021-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
spinal group	Levobupivacaine	Plain, isobaric levobupivacaine(0.25%) 0.25 mg/kg
caudal group	Levobupivacaine	Plain, isobaric levobupivacaine (0.25%) 1 ml/kg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Total consumption of rescue analgesics	24 hours	mg/24

Trial Locations

Locations (1)

Assiut governorate; 🇪🇬 Assiut, Egypt