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Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery (ITVSEpidural)

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%
caudal plain bupivacaine 2.5mg/kg 0.25%
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 2-12 years.
  • Weight: 15-40 kg.
  • Sex: both males and females.
  • ASA physical status: 1-II.
  • Operation: surgery below umbilicus.

Exclusion Criteria:

  • Allergic reaction to local anesthetics (LAs).
  • Local or systemic infection (risk of meningitis).
  • Coagulopathy.
  • Intracranial hypertension.
  • Hydrocephalus.
  • Intracranial hemorrhage.
  • Parental refusal.
  • Hypovolemia.
  • 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

  • Hala Saad Abdel-Ghaffar

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Spinal group

Caudal group

Arm Description

Intrathecal hyperbaric bupivacaine 0.25mg/kg will be give by lumber puncture that will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad. be given by .

caudal plain bupivacaine 2.5mg/kg 0.25% will be given caudally in The sacral hiatus between the sacral conru that will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance "give" or "pop" will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2-3mm deeper.

Outcomes

Primary Outcome Measures

FLACC Score
FLACC scores will be recorded.

Secondary Outcome Measures

Total consumption of rescue analgesics
The total consumption of postoperative rescue analgesics will be recorded.
Postoperative Agitation
Postoperative agitation will be evaluated by the Four Point Agitation Sedation scale.
Adverse effects
Any adverse effect will be treated and recorded.
Residual motor paralysis
By the Modified Bromage scale

Full Information

First Posted
November 25, 2016
Last Updated
January 12, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02988700
Brief Title
Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery
Acronym
ITVSEpidural
Official Title
Safety and Analgesic Efficacy of Spinal Versus Caudal Block in Pediatric Infra-umbilical Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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 analgesia for approximately 4-6 hours. Recently, the use of spinal anesthesia in infants and children requiring surgeries of sub-umbilical region is gaining considerable popularity worldwide. - The ease of performance and the safety regarding cardio-respiratory functions makes spinal anesthesia as an alternative to general anesthesia in infants and children undergoing surgeries of sub-umbilical regions.
Detailed Description
The historic view that young children neither respond to, nor remember, painful experiences to the same degree as adults is no longer thought to be true. About 40% of pediatric surgical patients experienced moderate or severe postoperative pain and 75% had insufficient analgesia. -Pediatric acute pain services use techniques of concurrent or co-analgesia based on four classes of analgesics, namely local anesthetics, opioids, non-steroidal anti-inflammatory drugs (NSAIDs), and acetaminophen (paracetamol). 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 analgesia for approximately 4-6 hours. Recently, the use of spinal anesthesia in infants and children requiring surgeries of sub-umbilical region is gaining considerable popularity worldwide. - The ease of performance and the safety regarding cardio-respiratory functions makes spinal anesthesia as an alternative to general anesthesia in infants and children undergoing surgeries of sub-umbilical regions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal group
Arm Type
Active Comparator
Arm Description
Intrathecal hyperbaric bupivacaine 0.25mg/kg will be give by lumber puncture that will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad. be given by .
Arm Title
Caudal group
Arm Type
Active Comparator
Arm Description
caudal plain bupivacaine 2.5mg/kg 0.25% will be given caudally in The sacral hiatus between the sacral conru that will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance "give" or "pop" will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2-3mm deeper.
Intervention Type
Drug
Intervention Name(s)
Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%
Other Intervention Name(s)
Marcain
Intervention Description
The lumber puncture will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad.
Intervention Type
Drug
Intervention Name(s)
caudal plain bupivacaine 2.5mg/kg 0.25%
Other Intervention Name(s)
Bucain
Intervention Description
The sacral hiatus between the sacral conru will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance "give" or "pop" will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2-3mm deeper.
Primary Outcome Measure Information:
Title
FLACC Score
Description
FLACC scores will be recorded.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Total consumption of rescue analgesics
Description
The total consumption of postoperative rescue analgesics will be recorded.
Time Frame
24 hours
Title
Postoperative Agitation
Description
Postoperative agitation will be evaluated by the Four Point Agitation Sedation scale.
Time Frame
60 min.
Title
Adverse effects
Description
Any adverse effect will be treated and recorded.
Time Frame
24 hours
Title
Residual motor paralysis
Description
By the Modified Bromage scale
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 2-12 years. Weight: 15-40 kg. Sex: both males and females. ASA physical status: 1-II. Operation: surgery below umbilicus. Exclusion Criteria: Allergic reaction to local anesthetics (LAs). Local or systemic infection (risk of meningitis). Coagulopathy. Intracranial hypertension. Hydrocephalus. Intracranial hemorrhage. Parental refusal. Hypovolemia. Spinal deformities, such as spina bifida or myelomeningocele. Presence of a ventriculoperitoneal shunt because of a risk of shunt infection or dural leak.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala S Abdel-Ghaffar, MD
Organizational Affiliation
Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hala Saad Abdel-Ghaffar
City
Assiut
State/Province
Assiut Governorate
ZIP/Postal Code
715715
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Spinal Versus Caudal Analgesia After Pediatric Infra-umbilical Surgery

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