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Caudal Block and Transversus Abdominis Plane Block in Pediatric Inguinal Hernia Repair

Primary Purpose

Regional Anesthesia, Postoperative Pain, Acute

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bupivacaine 0.25% Injectable Solution
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Regional Anesthesia focused on measuring US guided Caudal Epidural Block, US guided Transversus Abdominis Plane Block

Eligibility Criteria

1 Year - 7 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • patients aged 1-7 years who were scheduled for elective bilateral open IHR included in the study

Exclusion Criteria:

  • Patients with relative or absolute contraindications to TAPB or CEB, patients with chronic constipation or chronic pain disorders that may affect the evaluation of postoperative pain scores, patients who underwent emergency surgery, and patients with a history of allergic reaction to local anesthetics were excluded from the study.

Sites / Locations

  • Meltem Savran Karadeniz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Transversus Abdominis Plane Block

Caudal Epidural Block

Arm Description

US-guided Transversus Abdominis Plane Block was applied with 0.5 ml/kg of %25 Bupivacaine at each side before the surgical incision

US-guided Caudal Block was applied with 0.7ml/kg of %25 Bupivacaine before the surgical incision

Outcomes

Primary Outcome Measures

FLACC SCORES (FACE, LEG, ACTIVITY, CONSOLABILITY, CRY)
It includes five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0 to 10. Total scores of 0-3 is defined as mild, 4-7 as moderate, and 8-10 as severe pain.

Secondary Outcome Measures

PONV (Postoperative nausea and vomiting)
Number of patients with nausea vomiting
Additional analgesic requirement
Number of patients who require paracetamol (15 mg/kg) and tramadol (1 mg/kg)
Family satisfaction
A 3-point scale (satisfied:3; neutral:2, dissatisfied:1)
Surgeon satisfaction
A 3-point scale (satisfied:3; neutral:2, dissatisfied:1)
Complications
Possible complications related to caudal and transversus abdominis plane block (hematoma, infection and perforation)
Revised Bieri faces pain scale
Revised Bieri faces pain scale used for assessment of chronic pain. Score the chosen face 0,2,4,6,8,10 counting left to right so '0'=no pain and '10'=very much pain
Length of hospital stay
Hospitalisation

Full Information

First Posted
March 9, 2022
Last Updated
March 28, 2022
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT05286190
Brief Title
Caudal Block and Transversus Abdominis Plane Block in Pediatric Inguinal Hernia Repair
Official Title
Effects Of Ultrasound Guided Caudal Epidural And Transversus Abdominis Plane Block On Postoperative Analgesia In Pediatric Inguinal Hernia Repair Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
October 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul 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
Pediatric inguinal hernia repair (IHR) candidates experiences ordinarily mild to moderate pain, rarely severe pain in the postoperative period. Caudal epidural block (CEB) and transversus abdominis plane block (TAPB) are two effective postoperative analgesia options. In this randomized study, it is aimed to compare the effects of CEB and TAPB on postoperative pain scores, additional analgesic requirement, postoperative nausea and vomiting incidence, procedural complications, family and surgeon satisfaction, length of hospital stay, chronic pain development in pediatric bilateral open IHR.
Detailed Description
Inguinal hernia repair (IHR) is the second common operation in pediatric surgery practice following appendectomy and bilateral repair is needed in 10.9% of the cases due to presence of contralateral inguinal hernia. After IHR, the children generally experiences mild to moderate pain, and occasional severe pain. For pediatric population the prevalence of chronic pain after IHR is 5% which is a solid cause for severe pain. Adequate pain control is a crucial part of perioperative management to reduce morbidity and ensure family and patient satisfaction especially after pediatric surgeries. Although there are substantial studies to show how to assess and manage the postoperative pain in children, the pain control is often not achieved. Several analgesic regimens including systemic medications and/or regional analgesia methods may be preferred by clinicians. As previous studies revealed; best combination for pain management after pediatric IHR is still obscure. Caudal epidural block (CEB) and transversus abdominis plane block (TAPB) are the two regional analgesia methods which may be chosen for multimodal analgesia. CEB is accepted as gold standard for lower abdominal surgeries in children which diminishes somatic and visceral pain with a duration of 6 hours. TAPB is another regional analgesia method which covers only somatic pain up to 24 hours postoperatively with lower complication rates compared to CEB. The results of clinical studies examining the effects of CEB and TAPB on early postoperative pain after pediatric IHR are conflicting. Currently, the effects of these blocks on the incidence of chronic pain after pediatric IHR is not well-investigated in the literature. As a matter of fact, there are no recommendations for bilateral IHR in pediatric postoperative pain guidelines, despite these surgical procedures being an independent risk factor for severe pain. In this randomized study, it is aimed to compare the effects of ultrasound (US) guided CEB and TAPB on postoperative analgesia. Our hypothesis was that bilateral TAPB block will be equally effective as CEB in the early postoperative period and the analgesic duration will be longer than CEB. Our primary outcome was FLACC (face, legs, activity, cry, consolability) scores in postoperative 24 hours. The secondary outcomes included additional analgesic requirements, postoperative nausea vomiting incidence, procedural complications, length of hospital stay, family and surgeon satisfaction and chronic pain development at the postoperative 2nd month.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Anesthesia, Postoperative Pain, Acute
Keywords
US guided Caudal Epidural Block, US guided Transversus Abdominis Plane Block

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transversus Abdominis Plane Block
Arm Type
Active Comparator
Arm Description
US-guided Transversus Abdominis Plane Block was applied with 0.5 ml/kg of %25 Bupivacaine at each side before the surgical incision
Arm Title
Caudal Epidural Block
Arm Type
Active Comparator
Arm Description
US-guided Caudal Block was applied with 0.7ml/kg of %25 Bupivacaine before the surgical incision
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25% Injectable Solution
Other Intervention Name(s)
Marcaine
Intervention Description
Bupivacaine 0.25% Injectable Solution
Primary Outcome Measure Information:
Title
FLACC SCORES (FACE, LEG, ACTIVITY, CONSOLABILITY, CRY)
Description
It includes five categories of behavior, each scored on 0-2 point scale so that total score ranges from 0 to 10. Total scores of 0-3 is defined as mild, 4-7 as moderate, and 8-10 as severe pain.
Time Frame
Up to 24 hours
Secondary Outcome Measure Information:
Title
PONV (Postoperative nausea and vomiting)
Description
Number of patients with nausea vomiting
Time Frame
Up to 24 hours
Title
Additional analgesic requirement
Description
Number of patients who require paracetamol (15 mg/kg) and tramadol (1 mg/kg)
Time Frame
Up to 24 hours
Title
Family satisfaction
Description
A 3-point scale (satisfied:3; neutral:2, dissatisfied:1)
Time Frame
Up to 24 hours
Title
Surgeon satisfaction
Description
A 3-point scale (satisfied:3; neutral:2, dissatisfied:1)
Time Frame
Up to 24 hours
Title
Complications
Description
Possible complications related to caudal and transversus abdominis plane block (hematoma, infection and perforation)
Time Frame
Up to 24 hours
Title
Revised Bieri faces pain scale
Description
Revised Bieri faces pain scale used for assessment of chronic pain. Score the chosen face 0,2,4,6,8,10 counting left to right so '0'=no pain and '10'=very much pain
Time Frame
At postoperative 2nd month
Title
Length of hospital stay
Description
Hospitalisation
Time Frame
Through study completion, an average of 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients aged 1-7 years who were scheduled for elective bilateral open IHR included in the study Exclusion Criteria: Patients with relative or absolute contraindications to TAPB or CEB, patients with chronic constipation or chronic pain disorders that may affect the evaluation of postoperative pain scores, patients who underwent emergency surgery, and patients with a history of allergic reaction to local anesthetics were excluded from the study.
Facility Information:
Facility Name
Meltem Savran Karadeniz
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34000
Country
Turkey

12. IPD Sharing Statement

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Caudal Block and Transversus Abdominis Plane Block in Pediatric Inguinal Hernia Repair

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