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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05117281
• Other study ID #: 17300727
• Status: Completed
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: October 15, 2021

Study information

• Verified date: November 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 15, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Hernia, Inguinal
• Pain, Postoperative

Intervention

Drug:
• Levobupivacaine
Plain, isobaric levobupivacaine (0.25%) 1 ml/kg
• Levobupivacaine
Plain, isobaric levobupivacaine (0.25%) 0.25 mg/kg

Locations

Country	Name	City	State
Egypt	Assiut governorate	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total consumption of rescue analgesics	mg/24	24 hours