Inguinal HerniaNCT03640598
Erector Spinae Versus Ilioinguinal/ Ilio-hypogastric Block in Children Undergoing Inguinal Surgeries
A study testing Ilioinguinal/iliohypogastric nerve blocks and Erector spinae nerve block in people with Inguinal Hernia, run by Mansoura University at 1 site in Egypt.
Trial summary
Investigators aim to compare the efficacy of US-guided II/IH nerve block versus US-guided ES block for pediatric unilateral inguinal hernia repair with respect to postoperative analgesia Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Ilioinguinal/iliohypogastric nerve blocks and Erector spinae 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 siteEgypt
- Study dates
- 20 Aug 2018to 1 Nov 2018
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- : American Society of Anesthesiologists physical status I - II
Who cannot join
- History of clinically significant cardiac disease.
- History of clinically significant hepatic disease.
- History of clinically significant renal disease.
- History of clinically significant neurological disease.
- Known allergy to local anaesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Erector Spinae Versus Ilioinguinal/ Ilio-hypogastric Block for Postoperative Analgesia in Children Undergoing Inguinal Surgeries
Investigators aim to compare the efficacy of US-guided II/IH nerve block versus US-guided ES block for pediatric unilateral inguinal hernia repair with respect to postoperative analgesia
Read the detailed description
regarding patient registry; a prior G power analysis was done. 24 per group was determined to achieve 80% power to detect a difference of 60 min in time to first rescue analgesia between the two groups with a significance level (α) of 0.05 using a two-sided two-sample t-test; 25 patients were included per group to replace any dropouts.
- Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences). Program version 22. Distribution of data will be first tested by the Shapiro test. Data will be presented as the mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, the unpaired t-test will be used to compare the mean values of both groups. For pain score, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.
- Conditions
- Inguinal Hernia
- Being tested
- Ilioinguinal/iliohypogastric nerve blocks, Erector spinae nerve 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.
Ilioinguinal/iliohypogastric nerve blocksProcedure or surgery
The patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks with0.5 ml/kg 0.125 mg/kg bupivacaine + fentanyl 2ug/ml injectate
Erector spinae nerve blockProcedure or surgery
The patient will receive ultrasound-guided erector spinae nerve block 0.5 ml/kg 0.125 bupivacaine + fentanyl 2ug/ml injectate.
| Study group | Role | What they receive |
|---|---|---|
| Ilioinguinal/iliohypogastric nerve blocks | Other | The patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks Receives: Procedure: Ilioinguinal/iliohypogastric nerve blocks |
| Erector spinae nerve block | Other | The patient will receive ultrasound-guided erector spinae nerve block Receives: Procedure: Erector spinae nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative CHEOPS scale
The scale includes six entries with an appropriate point evaluation focused on the character of crying (1-3 points), facial expressions (0-2 points), verbal reaction (0-2 points), position of the body (1-2 points), touch (1-2 points), and position of the legs (1-2 points). Minimum score is 4 (no pain) and maximum is 13 (maximum pain). Grades are summed together. CHEOPS has a minimum possible score of 4 points (no pain) to a maximum of 13 points (the worst pain).
When the postoperative pain score exceeded four, rescue analgesia was given with a 20mg/kg paracetamol suppository.
Measured: for 6 hours after surgery
Secondary outcomes (3)
Time to first analgesic request
Time to first analgesic request
Measured: during first 24 hours
number of patients requiring rescue analgesic
Measured: during first 24 hours
incidence of postoperative nausea and vomiting
Measured: during first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start20 Aug 2018
- Primary completion20 Oct 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enas A Abd el Motlb, MD, Study chair, Assistant Professor, Anesthesia Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640598
- Sponsor's protocol ID
- R.18.05.202
- Status last verified
- Mar 2019
- First submitted
- 18 Aug 2018
- Last updated
- 27 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Erector Spinae Versus Ilioinguinal/ Ilio-hypogastric Block for Postoperative Analgesia in Children Undergoing Inguinal Surgeries
- ClinicalTrials.gov ID
- NCT03640598
- Acronym / sponsor ID
- R.18.05.202
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 20 Oct 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 21 Aug 2018 (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.
Investigators aim to compare the efficacy of US-guided II/IH nerve block versus US-guided ES block for pediatric unilateral inguinal hernia repair with respect to postoperative analgesia
Detailed description
regarding patient registry; a prior G power analysis was done. 24 per group was determined to achieve 80% power to detect a difference of 60 min in time to first rescue analgesia between the two groups with a significance level (α) of 0.05 using a two-sided two-sample t-test; 25 patients were included per group to replace any dropouts.
- Statistical analysis: Data will be analyzed through SPSS (Statistical Package for Social Sciences). Program version 22. Distribution of data will be first tested by the Shapiro test. Data will be presented as the mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, the unpaired t-test will be used to compare the mean values of both groups. For pain score, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ilioinguinal/iliohypogastric nerve blocks | Other | Procedure: Ilioinguinal/iliohypogastric nerve blocksThe patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks |
| Erector spinae nerve block | Other | Procedure: Erector spinae nerve blockThe patient will receive ultrasound-guided erector spinae nerve block |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- : American Society of Anesthesiologists physical status I - II
Key exclusion criteria (5 listed)
- History of clinically significant cardiac disease.
- History of clinically significant hepatic disease.
- History of clinically significant renal disease.
- History of clinically significant neurological disease.
- Known allergy to local anaesthetics
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 |
|---|---|---|
| Ilioinguinal/iliohypogastric nerve blocksThe patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks with0.5 ml/kg 0.125 mg/kg bupivacaine + fentanyl 2ug/ml injectate | Procedure or surgery | Ilioinguinal/iliohypogastric nerve blocks |
| Erector spinae nerve blockThe patient will receive ultrasound-guided erector spinae nerve block 0.5 ml/kg 0.125 bupivacaine + fentanyl 2ug/ml injectate. | Procedure or surgery | Erector spinae nerve block |
Primary outcome
Postoperative CHEOPS scale
Time frame: for 6 hours after surgery
The scale includes six entries with an appropriate point evaluation focused on the character of crying (1-3 points), facial expressions (0-2 points), verbal reaction (0-2 points), position of the body (1-2 points), touch (1-2 points), and position of the legs (1-2 points). Minimum score is 4 (no pain) and maximum is 13 (maximum pain). Grades are summed together. CHEOPS has a minimum possible score of 4 points (no pain) to a maximum of 13 points (the worst pain). When the postoperative pain score exceeded four, rescue analgesia was given with a 20mg/kg paracetamol suppository.
3 secondary outcomes
Time to first analgesic request
Time frame: during first 24 hours
number of patients requiring rescue analgesic
Time frame: during first 24 hours
incidence of postoperative nausea and vomiting
Time frame: during first 24 hours
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 27 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
Enas A Abd el Motlb, MD study chair
Assistant Professor, Anesthesia Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ilioinguinal/iliohypogastric nerve blocks and Erector spinae nerve block in people with Inguinal Hernia, run by Mansoura University 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 1 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 27 Mar 2019. 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.
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?
Postoperative CHEOPS scale (time frame: for 6 hours after surgery). 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 27 Mar 2019.