Hernia, InguinalPhase 1NCT05600296
Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to the Combined Therapy With Spermatic Cord Block
A Phase 1 study testing Levobupivacaine, Ilioinguinal/iliohypogastric nerve block (IINB) and IINB+ Spermatic cord block in people with Hernia, Inguinal, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
This is a single center randomized, controlled, double-blinded, noninferiority study. Male pediatric patients who underwent inguinal herniotomy will be screened for eligibility. Patients will be randomly allocated to IINB and IINB/SCB groups with allocation ratio 1:1. Read more about this study
- Who is it for?
- Ages 12 to 60 months, men only
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Levobupivacaine, Ilioinguinal/iliohypogastric nerve block (IINB) and IINB+ Spermatic cord block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 15 May 2023
- Phase
- Phase 1
- 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 12 to 60 months
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Male pediatric patients
- underwent elective open unilateral inguinal herniotomy
- Informed written consent will be obtained from the parents or the legal guardian.
Who cannot join
- local infection at the puncture site,
- bleeding disorder,
- allergy to amide local anesthetics,
- history of clinically significant cardiac, hepatic, or renal disorders.
- neurological dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to the Combined Therapy With Spermatic Cord Block in Inguinal Herniotomy Operation in Children: a Randomized Controlled Study
This is a single center randomized, controlled, double-blinded, noninferiority study. Male pediatric patients who underwent inguinal herniotomy will be screened for eligibility. Patients will be randomly allocated to IINB and IINB/SCB groups with allocation ratio 1:1. The primary outcome measure will be the proportion of patients who needed rescue analgesia during the first postoperative 6 h. The secondary outcome measures will be intraoperative heart rate and mean arterial blood pressure (MAP), the postoperative pain FLACC pain scale, and intravenous paracetamol consumption, the incidence of adverse effects including hematoma, postoperative vomiting and fever.
Read the detailed description
Inguinal herniotomy in children is a frequent surgical procedure that require good postoperative analgesia. Ultrasound-guided ilioinguinal/iliohypogastric nerve block is a widely validated anesthetic technique for this procedureز
Currently, central neuraxial analgesic techniques have been replaced by ultrasoundguided interfascial plane blocks that have gained more popularity among anesthetists because they are safer, easily performed, associated with minor hemodynamic changes and can be done in the presence of contraindications of the neuraxial block .
Ultrasound-guided ilioinguinal/iliohypogastric nerve block (IINB) is commonly done in pediatric patients to control pain after lower abdominal surgeries and has been shown to be effective in controlling pain after inguinal hernia repair .
However IINB don't affect the genitofemoral neve that contributes the sensory innervation of the inguinal region. The spermatic cord (SC) is a unique male structure that contains the vas deferens, testicular arteries, the pampiniform plexus of veins, and the ilioinguinal nerve and genital branch of the genitofemoral nerve (GFN). To provide complete analgesia for inguinal hernia surgery, GFN should be blocked in addition to IINB .
- Conditions
- Hernia, Inguinal
- Being tested
- Levobupivacaine, Ilioinguinal/iliohypogastric nerve block (IINB), IINB+ Spermatic cord block
- Keywords
- inguinal herniotomy, ilioinguinal nerve block, iliohypogastric nerve block, spermatic cord block
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Evaluation the postoperative analgesic effects by using ultrasound-guided spermatic cord block (SCB) and IINB in children scheduled for elective open inguinal herniotomy. The study hypothesized that, the combined block with SCB and IINB would result in more effective postoperative analgesia than the use of IINB alone.
Ilioinguinal/iliohypogastric nerve block (IINB)Procedure or surgery
Ilioinguinal/iliohypogastric nerve block (IINB)
IINB+ Spermatic cord blockProcedure or surgery
IINB+ Spermatic cord block
| Study group | Role | What they receive |
|---|---|---|
| Ilioinguinal/iliohypogastric nerve block (IINB) | Active comparator | evaluate the postoperative analgesic effects with using ultrasound-guided ilioinguinal/iliohypogastric nerve block (IINB) in children scheduled for elective open inguinal herniotomy. Receives: Drug: Levobupivacaine; Procedure: Ilioinguinal/iliohypogastric nerve block (IINB) |
| IINB+ Spermatic cord block | Active comparator | evaluate the postoperative analgesic effects with using ultrasound-guided IINB + spermatic cord block (SCB) in children scheduled for elective open inguinal herniotomy. Receives: Drug: Levobupivacaine; Procedure: IINB+ Spermatic cord block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rescue Analgesia
Assessment of the proportion of patients who needed rescue analgesia. Intravenous paracetamol 15mg/kg will be given as a rescue analgesic if FLACC pain scale ≥ 4
Measured: From base line to 6 hours postoperatively
Post Operative Pain
Assessment of The pain level of the cases by (Face, Leg, Activity, Cry, Consolability) pain scale (FLACC ) means of the digital pain.
Measured: From base line to 6 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start1 Nov 2022
- Primary completion1 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egymedicalpedia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mona Gad, Assist.Prof., Principal investigator, Department of anesthesia and SICU,Faculty of medicine,Mansoura university , Egypt.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05600296
- Sponsor's protocol ID
- Mona Gad 2
- Status last verified
- Oct 2023
- First submitted
- 20 Oct 2022
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to the Combined Therapy With Spermatic Cord Block in Inguinal Herniotomy Operation in Children: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05600296
- Acronym / sponsor ID
- Mona Gad 2
- Conditions
- Hernia, Inguinal
- Keywords
- inguinal herniotomy, ilioinguinal nerve block, iliohypogastric nerve block, spermatic cord block
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 31 Oct 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.
This is a single center randomized, controlled, double-blinded, noninferiority study. Male pediatric patients who underwent inguinal herniotomy will be screened for eligibility. Patients will be randomly allocated to IINB and IINB/SCB groups with allocation ratio 1:1. The primary outcome measure will be the proportion of patients who needed rescue analgesia during the first postoperative 6 h. The secondary outcome measures will be intraoperative heart rate and mean arterial blood pressure (MAP), the postoperative pain FLACC pain scale, and intravenous paracetamol consumption, the incidence of adverse effects including hematoma, postoperative vomiting and fever.
Detailed description
Inguinal herniotomy in children is a frequent surgical procedure that require good postoperative analgesia. Ultrasound-guided ilioinguinal/iliohypogastric nerve block is a widely validated anesthetic technique for this procedureز
Currently, central neuraxial analgesic techniques have been replaced by ultrasoundguided interfascial plane blocks that have gained more popularity among anesthetists because they are safer, easily performed, associated with minor hemodynamic changes and can be done in the presence of contraindications of the neuraxial block .
Ultrasound-guided ilioinguinal/iliohypogastric nerve block (IINB) is commonly done in pediatric patients to control pain after lower abdominal surgeries and has been shown to be effective in controlling pain after inguinal hernia repair .
However IINB don't affect the genitofemoral neve that contributes the sensory innervation of the inguinal region. The spermatic cord (SC) is a unique male structure that contains the vas deferens, testicular arteries, the pampiniform plexus of veins, and the ilioinguinal nerve and genital branch of the genitofemoral nerve (GFN). To provide complete analgesia for inguinal hernia surgery, GFN should be blocked in addition to IINB .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ilioinguinal/iliohypogastric nerve block (IINB) | Active comparator | Drug: Levobupivacaine, Procedure: Ilioinguinal/iliohypogastric nerve block (IINB)evaluate the postoperative analgesic effects with using ultrasound-guided ilioinguinal/iliohypogastric nerve block (IINB) in children scheduled for elective open inguinal herniotomy. |
| IINB+ Spermatic cord block | Active comparator | Drug: Levobupivacaine, Procedure: IINB+ Spermatic cord blockevaluate the postoperative analgesic effects with using ultrasound-guided IINB + spermatic cord block (SCB) in children scheduled for elective open inguinal herniotomy. |
Who may qualify
- Ages
- 12 to 60 months
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male pediatric patients
- underwent elective open unilateral inguinal herniotomy
- Informed written consent will be obtained from the parents or the legal guardian.
Key exclusion criteria (5 listed)
- local infection at the puncture site,
- bleeding disorder,
- allergy to amide local anesthetics,
- history of clinically significant cardiac, hepatic, or renal disorders.
- neurological dysfunction
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 |
|---|---|---|
| LevobupivacaineEvaluation the postoperative analgesic effects by using ultrasound-guided spermatic cord block (SCB) and IINB in children scheduled for elective open inguinal herniotomy. The study hypothesized that, the combined block with SCB and IINB would result in more effective postoperative analgesia than the use of IINB alone. | Drug | IINB+ Spermatic cord block, Ilioinguinal/iliohypogastric nerve block (IINB) |
| Ilioinguinal/iliohypogastric nerve block (IINB)Ilioinguinal/iliohypogastric nerve block (IINB) | Procedure or surgery | Ilioinguinal/iliohypogastric nerve block (IINB) |
| IINB+ Spermatic cord blockIINB+ Spermatic cord block | Procedure or surgery | IINB+ Spermatic cord block |
Primary outcome
Rescue Analgesia
Time frame: From base line to 6 hours postoperatively
Assessment of the proportion of patients who needed rescue analgesia. Intravenous paracetamol 15mg/kg will be given as a rescue analgesic if FLACC pain scale ≥ 4
Post Operative Pain
Time frame: From base line to 6 hours postoperatively
Assessment of The pain level of the cases by (Face, Leg, Activity, Cry, Consolability) pain scale (FLACC ) means of the digital pain.
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 19 Oct 2023.
- 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.
Mona Gad, Assist.Prof. principal investigator
Department of anesthesia and SICU,Faculty of medicine,Mansoura university , Egypt.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Levobupivacaine, Ilioinguinal/iliohypogastric nerve block (IINB) and IINB+ Spermatic cord block in people with Hernia, Inguinal, run by Egymedicalpedia at 1 site in Egypt.
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 5 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 19 Oct 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 Egypt. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Rescue Analgesia (time frame: From base line to 6 hours postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Oct 2023.