- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05610943
Comparison of The Quadratus Lumborum Block and Ilioinguinal Iliohypogastric Nerve Block
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 Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
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Sisli, Istanbul, Turkey, 34376
- Şişli Hamidiye Etfal Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: quadratus lumborum nerve block
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.
|
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.
|
|
Active Comparator: Ilioinguinal Iliohypogastric Nerve Block
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FLACC score
Time Frame: 24 hours
|
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.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
systemic analgesic administration times
Time Frame: 24 hour
|
the first postoperative systemic analgesic administration time
|
24 hour
|
|
frequency of systemic analgesic use
Time Frame: 24 hour
|
the frequency of systemic analgesic use in the first 24 hours postoperatively
|
24 hour
|
|
complications
Time Frame: 24 hour
|
the complications related to the use of postoperative systemic analgesics and/or nerve block application
|
24 hour
|
Collaborators and Investigators
Investigators
- Study Director: sebnem turk, Şişli Hamidiye Etfal Training and Research Hospital
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2977
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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