Inguinal Hernia RepairPhase 1NCT05559437
Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block
A Phase 1 study testing Levo-bupivacaine 0.25 in people with Inguinal Hernia Repair and Pain, Postoperative, run by Egymedicalpedia at 1 site in Egypt.
Trial summary
Abdominal wall hernias are common, with a prevalence of 1.7% for all ages and 4% for those aged over 45 years. Inguinal hernias account for 75% of abdominal wall hernias, with a lifetime risk of 27% in men and 3% in women. Repair of inguinal hernia is one of the most common operations in general surgery Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Inguinal Hernia Repair, Pain, Postoperative
- What is being tested?
- Levo-bupivacaine 0.25
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 20 Apr 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- all patients undergoing elective or emergent unilateral inguinal hernia repair
- Patients scheduled for unilateral inguinal hernia repair
Who cannot join
- Patient refusal.
- Contraindication to neuraxial block.
- neuromuscular diseases (as myopathies, myasthenia gravies).
- Hematological diseases, bleeding or coagulation abnormality.
- Uncontrolled Psychiatric diseases,
- Local skin infection and sepsis at site of the block.
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- Known intolerance to the study drugs.
- Body Mass Index > 40 Kg/m2,
- Unstable cardiovascular condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to Posterior Quadratus Lumborum Block in Patients Undergoing Inguinal Hernia Repair
Abdominal wall hernias are common, with a prevalence of 1.7% for all ages and 4% for those aged over 45 years. Inguinal hernias account for 75% of abdominal wall hernias, with a lifetime risk of 27% in men and 3% in women. Repair of inguinal hernia is one of the most common operations in general surgery
Read the detailed description
The peripheral nerve block usage is increasing in popularity because it decreases pain as estimated by visual analogue scores/numerical rating pain scores postoperatively and decreases the need for postoperative analgesic usage thereby reducing opioid induced side effects like postoperative respiratory depression, nausea, vomiting, NSAID induced gastritis etc. Nerve blocks also shorten Post-Anesthesia Care Unit stay time, and also increases patient satisfaction .
Ultrasound-guided peripheral nerve blocks including ilioinguinal/ iliohypogastric nerve block and transversus abdominis plane block have been widely used and considered as effective traditional techniques for postoperative analgesia in inguinal hernia repair .
In recent years, the quadratus lumborum (QL) block is proposed to be an alternative regional block for both upper abdominal surgery and lower abdominal surgery.
The blockade of ilioinguinal/iliohypogastric nerves in the anterior abdominal wall has improved postoperative analgesia after open inguinal hernia repair and many other procedures.
The Quadratus Lumborum (QL) Block is a regional anesthetic technique which described by anesthesiologist "DR Rafael Blanco" in 2007. Quadratus Lumborum block allows the local anesthetic agent to spread between the posterior aspect of the Quadratus Lumborum muscle and the middle layer of the Thoracolumbar fascia, which is nearer to the thoracic paravertebral space. It has four approaches based on the point of drug deposition in relation to quadratus lumborum muscle. Drug is deposited on the anterolateral, posterior, anterior to the Quadratus Lumborum muscle in the three approaches. In fourth approach drug is deposited intramuscularly. It provides postoperative analgesia for longer duration .
- Conditions
- Inguinal Hernia Repair, Pain, Postoperative
- Being tested
- Levo-bupivacaine 0.25
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levo-bupivacaine 0.25Drug
The blockade of ilioinguinal/iliohypogastric nerves in the anterior abdominal wall has improved postoperative analgesia after open inguinal hernia repair. Other new blocks needs to be investigated
| Study group | Role | What they receive |
|---|---|---|
| Quadratus Lumborum Block group | Experimental | Quadratus lumborum group (Q) (n=30): patients will receive Quadratus Lumborum Block using 20 mL of 0.25% Levo-bupivacaine Receives: Drug: Levo-bupivacaine 0.25 |
| Ilioinguinal/Iliohypogastric Nerve Block group | Experimental | Ilioinguinal/Iliohypogastric Nerve Block group (I) (n=30): patients will receive Ilioinguinal/Iliohypogastric Nerve Block using 5 mL of 0.25%Levo- bupivacaine Receives: Drug: Levo-bupivacaine 0.25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Pain
All patients will be familiar with the use of the visual analogue scale score identifying 0 as no pain and 10 as worst imaginable pain.
Measured: 0 hour after the operation up to 24-hour analgesic after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start1 Oct 2022
- Primary completion1 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia RepairStudies 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
- Model description
- To investigate the effectiveness of ultrasound guided Ilioinguinal/Iliohypogastric ( II/IH) block compared to ultrasound guided Posterior Quadratus Lumborum (PQL) block in patients subjected to inguinal hernia repair.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 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
- NCT05559437
- Sponsor's protocol ID
- Mona Gad
- Status last verified
- Oct 2023
- First submitted
- 24 Sep 2022
- Last updated
- 19 Oct 2023
- 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 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 Posterior Quadratus Lumborum Block in Patients Undergoing Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT05559437
- Acronym / sponsor ID
- Mona Gad
- Conditions
- Inguinal Hernia Repair, Pain, Postoperative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- EgymedicalpediaIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 29 Sep 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.
Abdominal wall hernias are common, with a prevalence of 1.7% for all ages and 4% for those aged over 45 years. Inguinal hernias account for 75% of abdominal wall hernias, with a lifetime risk of 27% in men and 3% in women. Repair of inguinal hernia is one of the most common operations in general surgery
Detailed description
The peripheral nerve block usage is increasing in popularity because it decreases pain as estimated by visual analogue scores/numerical rating pain scores postoperatively and decreases the need for postoperative analgesic usage thereby reducing opioid induced side effects like postoperative respiratory depression, nausea, vomiting, NSAID induced gastritis etc. Nerve blocks also shorten Post-Anesthesia Care Unit stay time, and also increases patient satisfaction .
Ultrasound-guided peripheral nerve blocks including ilioinguinal/ iliohypogastric nerve block and transversus abdominis plane block have been widely used and considered as effective traditional techniques for postoperative analgesia in inguinal hernia repair .
In recent years, the quadratus lumborum (QL) block is proposed to be an alternative regional block for both upper abdominal surgery and lower abdominal surgery.
The blockade of ilioinguinal/iliohypogastric nerves in the anterior abdominal wall has improved postoperative analgesia after open inguinal hernia repair and many other procedures.
The Quadratus Lumborum (QL) Block is a regional anesthetic technique which described by anesthesiologist "DR Rafael Blanco" in 2007. Quadratus Lumborum block allows the local anesthetic agent to spread between the posterior aspect of the Quadratus Lumborum muscle and the middle layer of the Thoracolumbar fascia, which is nearer to the thoracic paravertebral space. It has four approaches based on the point of drug deposition in relation to quadratus lumborum muscle. Drug is deposited on the anterolateral, posterior, anterior to the Quadratus Lumborum muscle in the three approaches. In fourth approach drug is deposited intramuscularly. It provides postoperative analgesia for longer duration .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- To investigate the effectiveness of ultrasound guided Ilioinguinal/Iliohypogastric ( II/IH) block compared to ultrasound guided Posterior Quadratus Lumborum (PQL) block in patients subjected to inguinal hernia repair.
| Arm | Type | Receives |
|---|---|---|
| Quadratus Lumborum Block group | Experimental | Drug: Levo-bupivacaine 0.25Quadratus lumborum group (Q) (n=30): patients will receive Quadratus Lumborum Block using 20 mL of 0.25% Levo-bupivacaine |
| Ilioinguinal/Iliohypogastric Nerve Block group | Experimental | Drug: Levo-bupivacaine 0.25Ilioinguinal/Iliohypogastric Nerve Block group (I) (n=30): patients will receive Ilioinguinal/Iliohypogastric Nerve Block using 5 mL of 0.25%Levo- bupivacaine |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- all patients undergoing elective or emergent unilateral inguinal hernia repair
- Patients scheduled for unilateral inguinal hernia repair
Key exclusion criteria (9 listed)
- Patient refusal.
- Contraindication to neuraxial block.
- neuromuscular diseases (as myopathies, myasthenia gravies).
- Hematological diseases, bleeding or coagulation abnormality.
- Uncontrolled Psychiatric diseases,
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 |
|---|---|---|
| Levo-bupivacaine 0.25The blockade of ilioinguinal/iliohypogastric nerves in the anterior abdominal wall has improved postoperative analgesia after open inguinal hernia repair. Other new blocks needs to be investigated | Drug | Ilioinguinal/Iliohypogastric Nerve Block group, Quadratus Lumborum Block group |
Primary outcome
Post Operative Pain
Time frame: 0 hour after the operation up to 24-hour analgesic after surgery
All patients will be familiar with the use of the visual analogue scale score identifying 0 as no pain and 10 as worst imaginable 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: 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.
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 Levo-bupivacaine 0.25 in people with Inguinal Hernia Repair and Pain, Postoperative, 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 2 inclusion and 9 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?
Post Operative Pain (time frame: 0 hour after the operation up to 24-hour analgesic 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 19 Oct 2023.