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

NCT05117281 | Completed

• 1 other identifier: 17300727
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total consumption of rescue analgesics

  24 hours

Study Arms (2)

spinal group

ACTIVE COMPARATOR

Plain, isobaric levobupivacaine(0.25%) 0.25 mg/kg

Drug: Levobupivacaine

caudal group

ACTIVE COMPARATOR

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

Drug: Levobupivacaine

Interventions

Levobupivacaine DRUG

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

Also known as: Levobupivacaine hydrate

caudal group

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut governorate

Asyut, 715715, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 11, 2021
• Study Start: September 10, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 15, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-11

Locations

EG (1)