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

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT05117281
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
1.1
Actual Duration (Months)
52.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
Comparison of Postoperative Analgesic Efficacy of Caudal Block Versus Spinal Block With Levobupivacaine for Inguinal Hernia in Children: A Randomized Clinical Trial
Actual Study Start Date :
Sep 10, 2021
Actual Primary Completion Date :
Oct 1, 2021
Actual Study Completion Date :
Oct 15, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: spinal group

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Total consumption of rescue analgesics [24 hours]

      mg/24

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    2 Years to 10 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut governorate Assiut Egypt 715715

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ghada Mohammed AboelFadl, Principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05117281
    Other Study ID Numbers:
    • 17300727
    First Posted:
    Nov 11, 2021
    Last Update Posted:
    Dec 2, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pain, Postoperative
    Hernia, Inguinal
    Levobupivacaine

    Study Results

    No Results Posted as of Dec 2, 2021