Comparison of The Quadratus Lumborum Block and Ilioinguinal Iliohypogastric Nerve Block

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05610943

Collaborator

(none)

Enrollment

Location

Arms

3.3

Anticipated Duration (Months)

18.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain Inguinal Hernia Quadratus Lumborum Nerve Block	Procedure: ultrasound-guided quadratus lumborum nerve block Procedure: ultrasound-guided Ilioinguinal Iliohypogastric Nerve Block	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 10, 2023

Arms and Interventions

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.	Procedure: ultrasound-guided quadratus lumborum nerve block 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.	Procedure: ultrasound-guided Ilioinguinal Iliohypogastric Nerve Block 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.

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.

Procedure: ultrasound-guided quadratus lumborum nerve block

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.

Procedure: ultrasound-guided Ilioinguinal Iliohypogastric Nerve Block

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.

Outcome Measures

Primary Outcome Measures

FLACC score [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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 7 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sisli Hamidiye Etfal Training and Research Hospital	Sisli	Istanbul	Turkey	34376

Sponsors and Collaborators

Sisli Hamidiye Etfal Training and Research Hospital

Investigators

Study Director: sebnem turk, Sisli Hamidiye Etfal Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Mustafa Altınay, principal investigator, Sisli Hamidiye Etfal Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT05610943

Other Study ID Numbers:

2977

First Posted:

Nov 9, 2022

Last Update Posted:

Dec 29, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mustafa Altınay, principal investigator, Sisli Hamidiye Etfal Training and Research Hospital

quadratus lumborum nerve block

postoperative pain

inguinal herniae

ilio-inguinal iliohypogastric nerve block

Additional relevant MeSH terms:

Hernia

Pain, Postoperative

Hernia, Inguinal

Study Results

No Results Posted as of Dec 29, 2022