Comparison of Postoperative Analgesic Efficacy of Caudal Block Versus Spinal Block With Levobupivacaine for Inguinal Hernia in Children
Primary Purpose
Pain, Postoperative, Analgesia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Levobupivacaine
Levobupivacaine
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative
Eligibility Criteria
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.
Sites / Locations
- Assiut governorate
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
spinal group
caudal group
Arm Description
Plain, isobaric levobupivacaine(0.25%) 0.25 mg/kg
Plain, isobaric levobupivacaine (0.25%) 1 ml/kg
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Total consumption of rescue analgesics
mg/24
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05117281
Brief Title
Comparison of Postoperative Analgesic Efficacy of Caudal Block Versus Spinal Block With Levobupivacaine for Inguinal Hernia in Children
Official Title
Comparison of Postoperative Analgesic Efficacy of Caudal Block Versus Spinal Block With Levobupivacaine for Inguinal Hernia in Children: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Analgesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
spinal group
Arm Type
Active Comparator
Arm Description
Plain, isobaric levobupivacaine(0.25%) 0.25 mg/kg
Arm Title
caudal group
Arm Type
Active Comparator
Arm Description
Plain, isobaric levobupivacaine (0.25%) 1 ml/kg
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine
Other Intervention Name(s)
Levobupivacaine hydrate
Intervention Description
Plain, isobaric levobupivacaine (0.25%) 1 ml/kg
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine
Other Intervention Name(s)
levobupivacaine hydrate
Intervention Description
Plain, isobaric levobupivacaine (0.25%) 0.25 mg/kg
Primary Outcome Measure Information:
Title
FLACC scale FLACC scores will be recorded. FLACC scores will be recorded. FLACC score will be recorded
Description
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).
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Total consumption of rescue analgesics
Description
mg/24
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Assiut governorate
City
Assiut
ZIP/Postal Code
715715
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Comparison of Postoperative Analgesic Efficacy of Caudal Block Versus Spinal Block With Levobupivacaine for Inguinal Hernia in Children
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