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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Analgesia
• Intervention / Treatment: Drug: Levobupivacaine; Drug: Levobupivacaine

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 715715
    • Assiut governorate

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: spinal group; Plain, isobaric levobupivacaine(0.25%) 0.25 mg/kg	Drug: Levobupivacaine; Plain, isobaric levobupivacaine (0.25%) 1 ml/kg; Other Names: Levobupivacaine hydrate; Drug: Levobupivacaine; Plain, isobaric levobupivacaine (0.25%) 0.25 mg/kg; Other Names: levobupivacaine hydrate
Active Comparator: caudal group; Plain, isobaric levobupivacaine (0.25%) 1 ml/kg	Drug: Levobupivacaine; Plain, isobaric levobupivacaine (0.25%) 1 ml/kg; Other Names: Levobupivacaine hydrate; Drug: Levobupivacaine; Plain, isobaric levobupivacaine (0.25%) 0.25 mg/kg; Other Names: levobupivacaine hydrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FLACC scale FLACC scores will be recorded. FLACC scores will be recorded. FLACC score will be recorded	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).	24 hours postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2021
• Primary Completion (Actual): October 1, 2021
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: November 1, 2021
• First Submitted That Met QC Criteria: November 1, 2021
• First Posted (Actual): November 11, 2021

Study Record Updates

• Last Update Posted (Actual): December 2, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Pain, Postoperative; Hernia, Inguinal; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Levobupivacaine
• Other Study ID Numbers: 17300727

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No