Back to resultsThe Comparison of the Transversalis Fascia Plane Block With Ilioinguinal/Iliohypogastric Nerve Block
Primary Purpose
Postoperative Pain, Inguinal Hernia Unilateral, Children, Only
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Transversalis Fascia Plane Block
Ilioinguinal/iliohypogastric Nerve Block
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring transversalis fascia, ilioinguinal/iliohypogastric nerve, inguinal hernia repair, children
Eligibility Criteria
Inclusion Criteria:
- the patients undergoing unilateral open hernia repair surgery
Exclusion Criteria:
- known allergy to local anesthetics, psychomotor retardation, anti-epileptic drugs usage, anti-inflammatory drug usage
Sites / Locations
- Ibaraki Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Transversalis Fascia Plane Block
Ilioinguinal/iliohypogastric Nerve Block
Arm Description
receive transversalis fascia plane block with 0.4 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia.
receive ilioinguinal/iliohypogastric nerve block with 0.1 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia.
Outcomes
Primary Outcome Measures
walking appearance
scoring a way of walking; 0: brisk walk, big step, able to skip (= no pain) to 5: not able to stand up ( = worst pain)
Secondary Outcome Measures
FLACC (face, legs, activity, cry, consolability) score
behavioral pain scale in children. Each category has 0 to 2 score; Total 0 (no pain) to 10 (worst)
Faces Pain Scale revised
self-reported pain score. Children choose a face from six faces.
additional pain curer usage
request or necessity of administration of acetaminophen or flurbiprofen
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03520907
Brief Title
The Comparison of the Transversalis Fascia Plane Block With Ilioinguinal/Iliohypogastric Nerve Block
Official Title
The Effect of the Transversalis Fascia Plane Block on Postoperative Pain Behavior After Hernia Repair Surgery in Children - Comparison With Conventional Ilioinguinal/Iliohypogastric Nerve Block-
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 26, 2018 (Actual)
Primary Completion Date
June 27, 2019 (Actual)
Study Completion Date
June 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kazuhiko Okuyama, MD
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
This study compares the transversalis fascia plane block with the ilioinguinal/iliohypogastric nerve block in children undergoing hernia repair surgery.
Half of participants will receive the transversalis fascia plane block, while the other will receive the ilioinguinal/iliohypogastric nerve block.
Detailed Description
The ilioinguinal/iliohypogastric nerve block (II/IH B)is a widely used regional anesthesia technique in inguinal hernia repair surgery. However, this block provides limited analgesia during and after surgery, and the patients feel pain when walking. The transversalis fascia plane block (TFPB) is a recently developed technique and several case reports presented its efficacy for inguinal repair surgery in adult patients. It may block not only ilioinguinal and iliohypogastric nerves but also splanchnic nerves, which is conveyed via the thoracolumbar fascia. Therefore, we compare the effect of the TFPB and II/IH B on postoperative pain and walking form.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Inguinal Hernia Unilateral, Children, Only
Keywords
transversalis fascia, ilioinguinal/iliohypogastric nerve, inguinal hernia repair, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transversalis Fascia Plane Block
Arm Type
Experimental
Arm Description
receive transversalis fascia plane block with 0.4 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia.
Arm Title
Ilioinguinal/iliohypogastric Nerve Block
Arm Type
Active Comparator
Arm Description
receive ilioinguinal/iliohypogastric nerve block with 0.1 ml/kg of 0.25% levobupivacaine after establishment of general anesthesia.
Intervention Type
Drug
Intervention Name(s)
Transversalis Fascia Plane Block
Other Intervention Name(s)
TFPB
Intervention Description
block will be performed under real-time ultrasound guidance
Intervention Type
Drug
Intervention Name(s)
Ilioinguinal/iliohypogastric Nerve Block
Other Intervention Name(s)
II/IH B
Intervention Description
block will be performed under real-time ultrasound guidance
Primary Outcome Measure Information:
Title
walking appearance
Description
scoring a way of walking; 0: brisk walk, big step, able to skip (= no pain) to 5: not able to stand up ( = worst pain)
Time Frame
3 to 5 hours after surgery
Secondary Outcome Measure Information:
Title
FLACC (face, legs, activity, cry, consolability) score
Description
behavioral pain scale in children. Each category has 0 to 2 score; Total 0 (no pain) to 10 (worst)
Time Frame
3 to 5 hours after surgery
Title
Faces Pain Scale revised
Description
self-reported pain score. Children choose a face from six faces.
Time Frame
3 to 5 hours after surgery
Title
additional pain curer usage
Description
request or necessity of administration of acetaminophen or flurbiprofen
Time Frame
up to 5 hours after surgery
Other Pre-specified Outcome Measures:
Title
intraoperative heart rate changes
Description
heart rate during surgery
Time Frame
just before surgery start, one minute after incision, maximum value during surgery
Title
intraoperative respiratory rate changes
Description
respiratory rate during surgery
Time Frame
just before surgery start, one minute after incision, maximum value during surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
the patients undergoing unilateral open hernia repair surgery
Exclusion Criteria:
known allergy to local anesthetics, psychomotor retardation, anti-epileptic drugs usage, anti-inflammatory drug usage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuhiko Okuyama, MD
Organizational Affiliation
Ibaraki Children's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ibaraki Children's Hospital
City
Mito
State/Province
Ibaraki
ZIP/Postal Code
311-4145
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Comparison of the Transversalis Fascia Plane Block With Ilioinguinal/Iliohypogastric Nerve Block
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