Liver CirrhosisNCT04553328
Ultrasound-guided Ipsilateral Transverse Abdominis Plane and Ilioinguinal Iliohypogastric Nerve Block.
A study testing Us guided nerve blocks in people with Liver Cirrhosis, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study is to compare the efficacy of using TAB and ILIH nerve blocks versus ILIH nerve block only for inguinal hernia repair in patients with liver cirrhosis. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Us guided nerve blocks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 2 Jun 2020
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status classification groups II and III,undergoing unilateral inguinal hernia repair.
- All patients have liver cirrhosis having a Child-Pugh classification of liver disease (3) class B with a score ≤ 8/15,
- Moemen modified classification of liver disease (4) class B,
- an international normalized ratio (INR)≤1.5.
Who cannot join
- Patients with Child-Pugh ≥ 8/15,
- INR≥ 1.5,
- Grade 3 ascites,
- Serum sodium ≤120 meq/l,
- Recurrent hernia, or bilateral hernia,
- Body mass index (BMI) ≥ to 40 kg/m 2,
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- known allergy to any of the medicines used
- Any renal or cardiovascular dysfunction, bronchial asthma, hematological disorders (other than secondary to chronic liver disease),
- Patient refusal.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Ipsilateral Transverse Abdominis Plane and Ilioinguinal-iliohypogastric Nerve Block Versus Ipsilateral Illioinguinal- Illiohypogastric Nerve Block for Inguinal Hernia Repair in Patients With Liver Cirrhosis
The purpose of this study is to compare the efficacy of using TAB and ILIH nerve blocks versus ILIH nerve block only for inguinal hernia repair in patients with liver cirrhosis.
Read the detailed description
After obtaining institutional ethical committee approval and written informed consent in 2019, 60 patients between the age of 40 and 70 year were divided randomly using a computer generated randomization table and opaque sealed envelopes into two groups (30 patients in each group) according to the type of block they received: Group (T) received ultrasound guided (US) combined ipsilateral transverse abdominis plane (TAB) and ilioinguinal- iliohypogastric (ILIH) nerve block. Group (I) received US guided ipsilateral illioinguinal- illiohypogastric nerve block only.
Standard monitoring was used throughout the surgery; heart rate (HR), non-invasive mean arterial blood pressure (MAP), respiratory rate (RR) and oxygen saturation (SpO2)documented at baseline before the block then at 5-min intervals intraoperative , then during the immediate postoperative period at 15 and 30 min, and at discharge from the PACU.
A nasal prong was applied and supplemental oxygen at 3 l/min of fresh gas flow was given throughout the procedure. It was explained clearly to the patients that any pain, discomfort, or anxiety would be managed by the administration of local anesthetic (LA) infiltration with bupivacaine 0.25% during the operation or by conversion to general anesthesia (GA) if needed.
- Conditions
- Liver Cirrhosis
- Being tested
- Us guided nerve blocks
- Keywords
- Transverse aabdominis plane
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Us guided nerve blocksDevice
Also called drug used is bupivacaine
The ILIH nerves were identified and located in the fascia compartment between the internal oblique and the transverse abdominis or external oblique muscles, a 20 G needle was advanced between the aponeurosis of the internal oblique and transverses abdominis muscles then 30 ml bupivacaine 0.25% was injected with intermittent aspiration,then 10 ml bupivacaine 0.25% was injected around the nerves.
| Study group | Role | What they receive |
|---|---|---|
| Group T | Active comparator | Group (T) received ultrasound guided (US) combined ipsilateral transverse abdominis plane (TAB) and ilioinguinal- iliohypogastric (ILIH) nerve block Receives: Device: Us guided nerve blocks |
| Group I | Active comparator | Group (I) received US guided ipsilateral illioinguinal- illiohypogastric nerve block only. Receives: Device: Us guided nerve blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
local anesthetic infiltration and convesion to general anesthesia
need for additional local anesthetic infiltration and conversion to general anesesthesia by assessing sensory block adequacy with thermal sensation using an alcohol swab.
Measured: data will be reported and assessed within 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start1 Sep 2019
- Primary completion20 Apr 2020
- Study completion2 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Model description
- The patients were divided randomly into two groups (30 patients in each group) according to the type of block they received: Group (T) received ultrasound guided (US) combined ipsilateral transverse abdominis plane (TAB) and ilioinguinal- iliohypogastric (ILIH) nerve block. Group (I) received US guided ipsilateral illioinguinal- illiohypogastric nerve block only.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Salah Eldin Mahmoud Badre, Ain Shams University
- Investigators
- Dina Badre, PHD, Principal investigator, Associate professor of Anesthesia and ICU, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553328
- Sponsor's protocol ID
- FMASU R 48/2019
- Status last verified
- Sep 2020
- First submitted
- 14 Aug 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final results are to be shared with other researchers after approval of publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Ipsilateral Transverse Abdominis Plane and Ilioinguinal-iliohypogastric Nerve Block Versus Ipsilateral Illioinguinal- Illiohypogastric Nerve Block for Inguinal Hernia Repair in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT04553328
- Acronym / sponsor ID
- FMASU R 48/2019
- Conditions
- Liver Cirrhosis
- Keywords
- Transverse aabdominis plane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 17 Sep 2020 (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.
The purpose of this study is to compare the efficacy of using TAB and ILIH nerve blocks versus ILIH nerve block only for inguinal hernia repair in patients with liver cirrhosis.
Detailed description
After obtaining institutional ethical committee approval and written informed consent in 2019, 60 patients between the age of 40 and 70 year were divided randomly using a computer generated randomization table and opaque sealed envelopes into two groups (30 patients in each group) according to the type of block they received: Group (T) received ultrasound guided (US) combined ipsilateral transverse abdominis plane (TAB) and ilioinguinal- iliohypogastric (ILIH) nerve block. Group (I) received US guided ipsilateral illioinguinal- illiohypogastric nerve block only.
Standard monitoring was used throughout the surgery; heart rate (HR), non-invasive mean arterial blood pressure (MAP), respiratory rate (RR) and oxygen saturation (SpO2)documented at baseline before the block then at 5-min intervals intraoperative , then during the immediate postoperative period at 15 and 30 min, and at discharge from the PACU.
A nasal prong was applied and supplemental oxygen at 3 l/min of fresh gas flow was given throughout the procedure. It was explained clearly to the patients that any pain, discomfort, or anxiety would be managed by the administration of local anesthetic (LA) infiltration with bupivacaine 0.25% during the operation or by conversion to general anesthesia (GA) if needed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The patients were divided randomly into two groups (30 patients in each group) according to the type of block they received: Group (T) received ultrasound guided (US) combined ipsilateral transverse abdominis plane (TAB) and ilioinguinal- iliohypogastric (ILIH) nerve block. Group (I) received US guided ipsilateral illioinguinal- illiohypogastric nerve block only.
| Arm | Type | Receives |
|---|---|---|
| Group T | Active comparator | Device: Us guided nerve blocksGroup (T) received ultrasound guided (US) combined ipsilateral transverse abdominis plane (TAB) and ilioinguinal- iliohypogastric (ILIH) nerve block |
| Group I | Active comparator | Device: Us guided nerve blocksGroup (I) received US guided ipsilateral illioinguinal- illiohypogastric nerve block only. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) physical status classification groups II and III,undergoing unilateral inguinal hernia repair.
- All patients have liver cirrhosis having a Child-Pugh classification of liver disease (3) class B with a score ≤ 8/15,
- Moemen modified classification of liver disease (4) class B,
- an international normalized ratio (INR)≤1.5.
Key exclusion criteria (9 listed)
- Patients with Child-Pugh ≥ 8/15,
- INR≥ 1.5,
- Grade 3 ascites,
- Serum sodium ≤120 meq/l,
- Recurrent hernia, or bilateral hernia,
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 |
|---|---|---|
| Us guided nerve blocksAlso: drug used is bupivacaineThe ILIH nerves were identified and located in the fascia compartment between the internal oblique and the transverse abdominis or external oblique muscles, a 20 G needle was advanced between the aponeurosis of the internal oblique and transverses abdominis muscles then 30 ml bupivacaine 0.25% was injected with intermittent aspiration,then 10 ml bupivacaine 0.25% was injected around the nerves. | Device | Group I, Group T |
Primary outcome
local anesthetic infiltration and convesion to general anesthesia
Time frame: data will be reported and assessed within 24 weeks.
need for additional local anesthetic infiltration and conversion to general anesesthesia by assessing sensory block adequacy with thermal sensation using an alcohol swab.
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 17 Sep 2020.
- Individual participant dataSharing planned: Yes. Final results are to be shared with other researchers after approval of publication
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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.
Dina Badre, PHD principal investigator
Associate professor of Anesthesia and ICU, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Us guided nerve blocks in people with Liver Cirrhosis, run by Ain Shams 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 4 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 17 Sep 2020. 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?
local anesthetic infiltration and convesion to general anesthesia (time frame: data will be reported and assessed within 24 weeks.). 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 17 Sep 2020.