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

NCT ID: NCT05117281

Last Updated: 2021-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-10

Study Completion Date

2021-10-15

Brief Summary

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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

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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.

Conditions

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Pain, Postoperative Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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spinal group

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

Group Type ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type DRUG

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

caudal group

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

Group Type ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type DRUG

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

Interventions

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Levobupivacaine

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

Intervention Type DRUG

Levobupivacaine

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

Intervention Type DRUG

Other Intervention Names

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Levobupivacaine hydrate levobupivacaine hydrate

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Mohammed AboelFadl

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut governorate

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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17300727

Identifier Type: -

Identifier Source: org_study_id