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Comparison of The Quadratus Lumborum Block and Ilioinguinal Iliohypogastric Nerve Block

Primary Purpose

Post Operative Pain, Inguinal Hernia, Quadratus Lumborum Nerve Block

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
ultrasound-guided quadratus lumborum nerve block
ultrasound-guided Ilioinguinal Iliohypogastric Nerve Block
Sponsored by
Sisli Hamidiye Etfal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring quadratus lumborum nerve block, postoperative pain, inguinal herniae, ilio-inguinal iliohypogastric nerve block

Eligibility Criteria

2 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: who were scheduled for unilateral inguinal hernia operation with American Society of Anesthesiologists (ASA) physical score I-II aged 2-7 years Exclusion Criteria: Patients with coagulopathy skin infection at the block application site bupivacaine allergy neuropsychiatric disease

Sites / Locations

  • Sisli Hamidiye Etfal Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

quadratus lumborum nerve block

Ilioinguinal Iliohypogastric Nerve Block

Arm Description

In Group Q; The patient was placed in the lateral position with the side to be blocked on top. After providing skin antisepsis with 5% povidone iodine, sterile dressing was applied. After the USG probe was covered with a sterile sheath, it was placed transversely between the iliac crest and the costa edge. After imaging the external-internal oblique and transversus abdominis muscles, the probe was advanced posteriorly. Quadratus lumborum, Psoas Major and Erector Spina muscles were visualized. The needle was advanced towards the middle thoracolumbar fascia between the Quadratus lumborum muscle and the Erector Spina muscle with the in-plane technique, and the location was confirmed by injecting 1 ml of 0.9 saline. 0.25% Bupivacaine was injected at a dose of 0.5 mL/kg after negative aspiration.

In Group I; The patient was placed in the supine position. After providing skin antisepsis with 5% povidone iodine, sterile dressing was applied. After the USG probe was covered with a sterile sheath, it was placed on the anterior abdominal wall parallel to the imaginary line between the umbilicus and the anterior superior iliac wing. After imaging the external-internal oblique and transversus abdominis muscles, the ilioinguinal-iliohypogastric nerve was visualized as two small hypoechoic areas between the internal oblique muscle and the transversus abdominis muscle. The location was confirmed by injecting 1 ml of 0.9 saline by advancing the needle with the in-plane technique close to the nerve structures. 0.25% Bupivacaine was injected at a dose of 0.5 mL/kg after negative aspiration.

Outcomes

Primary Outcome Measures

FLACC score
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Scale. FLACC is a behavioral pain assessment scale used for nonverbal or preverbal patients who are unable to self-report their level of pain. Pain is assessed through observation of 5 categories including face, legs, activity, cry, and consolability. The increase in the pain felt by the patient also increases the flacc score. Each category is scored on the 0-2 scale which results in a total score of 0-10.

Secondary Outcome Measures

systemic analgesic administration times
the first postoperative systemic analgesic administration time
frequency of systemic analgesic use
the frequency of systemic analgesic use in the first 24 hours postoperatively
complications
the complications related to the use of postoperative systemic analgesics and/or nerve block application

Full Information

First Posted
October 28, 2022
Last Updated
March 2, 2023
Sponsor
Sisli Hamidiye Etfal Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05610943
Brief Title
Comparison of The Quadratus Lumborum Block and Ilioinguinal Iliohypogastric Nerve Block
Official Title
Comparison of The Postoperative Analgesic Effectiveness of Ultrasound-Guided Quadratus Lumborum Block and Ilioinguinal Iliohypogastric Nerve Block in Pediatric Inguinal Hernia Operation, Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
March 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sisli Hamidiye Etfal Training and Research Hospital

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
Perioperative and postoperative pain control in pediatric patients is a frequently neglected issue. Regional anesthesia applications reduce adverse drug events by minimizing opioid consumption and provide effective and safe analgesia. In recent years, quadratus lumborum block has emerged as an alternative regional anesthesia technique and it has been shown to provide analgesia as effectively as caudal block in children, and in a limited number of studies it has been said that it is more effective than transversus abdominis plane block. There are few studies in the literature comparing ilioinguinal iliohypogastic nerve block and quadratus lumborum block in children.
Detailed Description
Perioperative and postoperative pain control in pediatric patients is a frequently neglected issue. Providing effective perioperative analgesia reduces surgical stress, making the postoperative period more comfortable both physiologically and psychologically, effective postoperative pain control reduces the length of stay in the hospital, and also contributes to the long-term positive personality development of children. Physiological, pharmacokinetic and pharmacodynamic differences in children delay the metabolism and excretion of systemic analgesics, resulting in a prolonged effect and an increased risk of apnea. Regional anesthesia applications reduce adverse drug events by minimizing opioid consumption and provide effective and safe analgesia. Caudal block, which is a common regional anesthesia practice in inguinal hernia surgery in children, has disadvantages such as motor block and urinary retention. With the introduction of ultrasonography, peripheral block techniques such as transversus abdominis plane block and ilioinguinal iliohypogastric nerve block have been shown to provide effective and safe analgesia and have replaced central blocks. In recent years, quadratus lumborum block has emerged as an alternative regional anesthesia technique and it has been shown to provide analgesia as effectively as caudal block in children, and in a limited number of studies it has been said that it is more effective than transversus abdominis plane block. There are few studies in the literature comparing ilioinguinal iliohypogastric nerve block and quadratus lumborum block in children. The purpose of the study to compare the postoperative analgesic effectiveness of quadratus lumborum block and ilioinguinal iliohypogastric block in pediatric patients who underwent unilateral inguinal hernia operation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Inguinal Hernia, Quadratus Lumborum Nerve Block
Keywords
quadratus lumborum nerve block, postoperative pain, inguinal herniae, ilio-inguinal iliohypogastric nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
quadratus lumborum nerve block
Arm Type
Active Comparator
Arm Description
In Group Q; The patient was placed in the lateral position with the side to be blocked on top. After providing skin antisepsis with 5% povidone iodine, sterile dressing was applied. After the USG probe was covered with a sterile sheath, it was placed transversely between the iliac crest and the costa edge. After imaging the external-internal oblique and transversus abdominis muscles, the probe was advanced posteriorly. Quadratus lumborum, Psoas Major and Erector Spina muscles were visualized. The needle was advanced towards the middle thoracolumbar fascia between the Quadratus lumborum muscle and the Erector Spina muscle with the in-plane technique, and the location was confirmed by injecting 1 ml of 0.9 saline. 0.25% Bupivacaine was injected at a dose of 0.5 mL/kg after negative aspiration.
Arm Title
Ilioinguinal Iliohypogastric Nerve Block
Arm Type
Active Comparator
Arm Description
In Group I; The patient was placed in the supine position. After providing skin antisepsis with 5% povidone iodine, sterile dressing was applied. After the USG probe was covered with a sterile sheath, it was placed on the anterior abdominal wall parallel to the imaginary line between the umbilicus and the anterior superior iliac wing. After imaging the external-internal oblique and transversus abdominis muscles, the ilioinguinal-iliohypogastric nerve was visualized as two small hypoechoic areas between the internal oblique muscle and the transversus abdominis muscle. The location was confirmed by injecting 1 ml of 0.9 saline by advancing the needle with the in-plane technique close to the nerve structures. 0.25% Bupivacaine was injected at a dose of 0.5 mL/kg after negative aspiration.
Intervention Type
Procedure
Intervention Name(s)
ultrasound-guided quadratus lumborum nerve block
Intervention Description
The patient was placed in the lateral position with the side to be blocked on top. After providing skin antisepsis with 5% povidone iodine, sterile dressing was applied. After the USG probe was covered with a sterile sheath, it was placed transversely between the iliac crest and the costa edge. After imaging the external-internal oblique and transversus abdominis muscles, the probe was advanced posteriorly. Quadratus lumborum, Psoas Major and Erector Spina muscles were visualized. The needle was advanced towards the middle thoracolumbar fascia between the Quadratus lumborum muscle and the Erector Spina muscle with the in-plane technique, and the location was confirmed by injecting 1 ml of 0.9 saline. 0.25% Bupivacaine was injected at a dose of 0.5 mL/kg after negative aspiration.
Intervention Type
Procedure
Intervention Name(s)
ultrasound-guided Ilioinguinal Iliohypogastric Nerve Block
Intervention Description
The patient was placed in the supine position. After providing skin antisepsis with 5% povidone iodine, sterile dressing was applied. After the USG probe was covered with a sterile sheath, it was placed on the anterior abdominal wall parallel to the imaginary line between the umbilicus and the anterior superior iliac wing. After imaging the external-internal oblique and transversus abdominis muscles, the ilioinguinal-iliohypogastric nerve was visualized as two small hypoechoic areas between the internal oblique muscle and the transversus abdominis muscle. The location was confirmed by injecting 1 ml of 0.9 saline by advancing the needle with the in-plane technique close to the nerve structures. 0.25% Bupivacaine was injected at a dose of 0.5 mL/kg after negative aspiration.
Primary Outcome Measure Information:
Title
FLACC score
Description
Face, Legs, Activity, Cry, Consolability (FLACC) Behavioral Pain Scale. FLACC is a behavioral pain assessment scale used for nonverbal or preverbal patients who are unable to self-report their level of pain. Pain is assessed through observation of 5 categories including face, legs, activity, cry, and consolability. The increase in the pain felt by the patient also increases the flacc score. Each category is scored on the 0-2 scale which results in a total score of 0-10.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
systemic analgesic administration times
Description
the first postoperative systemic analgesic administration time
Time Frame
24 hour
Title
frequency of systemic analgesic use
Description
the frequency of systemic analgesic use in the first 24 hours postoperatively
Time Frame
24 hour
Title
complications
Description
the complications related to the use of postoperative systemic analgesics and/or nerve block application
Time Frame
24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: who were scheduled for unilateral inguinal hernia operation with American Society of Anesthesiologists (ASA) physical score I-II aged 2-7 years Exclusion Criteria: Patients with coagulopathy skin infection at the block application site bupivacaine allergy neuropsychiatric disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sebnem turk
Organizational Affiliation
Sisli Hamidiye Etfal Training and Research Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Sisli Hamidiye Etfal Training and Research Hospital
City
Sisli
State/Province
Istanbul
ZIP/Postal Code
34376
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32030845
Citation
Samerchua A, Leurcharusmee P, Panichpichate K, Bunchungmongkol N, Wanvoharn M, Tepmalai K, Khorana J, Chantakhow S. A Prospective, randomized comparative study between ultrasound-guided posterior quadratus lumborum block and ultrasound-guided ilioinguinal/iliohypogastric nerve block for pediatric inguinal herniotomy. Paediatr Anaesth. 2020 Apr;30(4):498-505. doi: 10.1111/pan.13837. Epub 2020 Feb 21.
Results Reference
background
PubMed Identifier
35039439
Citation
Priyadarshini K, Behera BK, Tripathy BB, Misra S. Ultrasound-guided transverse abdominis plane block, ilioinguinal/iliohypogastric nerve block, and quadratus lumborum block for elective open inguinal hernia repair in children: a randomized controlled trial. Reg Anesth Pain Med. 2022 Apr;47(4):217-221. doi: 10.1136/rapm-2021-103201. Epub 2022 Jan 17. Erratum In: Reg Anesth Pain Med. 2022 Jun;47(6):e2.
Results Reference
background

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Comparison of The Quadratus Lumborum Block and Ilioinguinal Iliohypogastric Nerve Block

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