Post Operative PainNCT05610943
Comparison of The Quadratus Lumborum Block and Ilioinguinal Iliohypogastric Nerve Block
A study testing ultrasound-guided quadratus lumborum nerve block and ultrasound-guided Ilioinguinal Iliohypogastric Nerve Block in people with Post Operative Pain and Inguinal Hernia, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Post Operative Pain, Inguinal Hernia, Quadratus Lumborum Nerve Block
- What is being tested?
- ultrasound-guided quadratus lumborum nerve block and ultrasound-guided Ilioinguinal Iliohypogastric Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- who were scheduled for unilateral inguinal hernia operation
- with American Society of Anesthesiologists (ASA) physical score I-II
- aged 2-7 years
Who cannot join
- Patients with coagulopathy
- skin infection at the block application site
- bupivacaine allergy
- neuropsychiatric disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sisli Hamidiye Etfal Training and Research Hospital
Şişli, Istanbul, 34376
About this study
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
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.
Read the 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.
- Being tested
- ultrasound-guided quadratus lumborum nerve block, ultrasound-guided Ilioinguinal Iliohypogastric Nerve Block
- Keywords
- quadratus lumborum nerve block, postoperative pain, inguinal herniae, ilio-inguinal iliohypogastric nerve block
- Medical subject headings
- Pain, Postoperative, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided quadratus lumborum nerve blockProcedure or surgery
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.
ultrasound-guided Ilioinguinal Iliohypogastric Nerve BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| quadratus lumborum nerve block | Active comparator | 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. Receives: Procedure: ultrasound-guided quadratus lumborum nerve block |
| Ilioinguinal Iliohypogastric Nerve Block | Active comparator | 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. Receives: Procedure: ultrasound-guided Ilioinguinal Iliohypogastric Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (3)
systemic analgesic administration times
the first postoperative systemic analgesic administration time
Measured: 24 hour
frequency of systemic analgesic use
the frequency of systemic analgesic use in the first 24 hours postoperatively
Measured: 24 hour
complications
the complications related to the use of postoperative systemic analgesics and/or nerve block application
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start1 Nov 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Altınay, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- sebnem turk, Study director, Sisli Hamidiye Etfal Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610943
- Sponsor's protocol ID
- 2977
- Status last verified
- Mar 2023
- First submitted
- 28 Oct 2022
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32030845Priyadarshini 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.
PubMed 35039439
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05610943
- Acronym / sponsor ID
- 2977
- Keywords
- quadratus lumborum nerve block, postoperative pain, inguinal herniae, ilio-inguinal iliohypogastric nerve block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| quadratus lumborum nerve block | Active comparator | Procedure: ultrasound-guided quadratus lumborum nerve blockIn 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. |
| Ilioinguinal Iliohypogastric Nerve Block | Active comparator | Procedure: ultrasound-guided Ilioinguinal Iliohypogastric Nerve BlockIn 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. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- who were scheduled for unilateral inguinal hernia operation
- with American Society of Anesthesiologists (ASA) physical score I-II
- aged 2-7 years
Key exclusion criteria (4 listed)
- Patients with coagulopathy
- skin infection at the block application site
- bupivacaine allergy
- neuropsychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound-guided quadratus lumborum nerve blockThe 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 or surgery | quadratus lumborum nerve block |
| ultrasound-guided Ilioinguinal Iliohypogastric Nerve BlockThe 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 or surgery | Ilioinguinal Iliohypogastric Nerve Block |
Primary outcome
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.
3 secondary outcomes
systemic analgesic administration times
Time frame: 24 hour
frequency of systemic analgesic use
Time frame: 24 hour
complications
Time frame: 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Background: PubMed 32030845Samerchua 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.
- Background: PubMed 35039439Priyadarshini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sebnem turk study director
Sisli Hamidiye Etfal Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guided quadratus lumborum nerve block and ultrasound-guided Ilioinguinal Iliohypogastric Nerve Block in people with Post Operative Pain and Inguinal Hernia, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC score (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05610943, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.