Inguinal HerniaNCT04266132
Ultrasound Guided Retrolaminar Block for Pediatric Inguinal Hernia
A study testing General anaesthesia, Ultrasound-guided RLB and Ultrasound-guided INB in people with Inguinal Hernia and Pediatric, run by Mahmoud Mohammed Alseoudy at 1 site in Egypt.
Trial summary
Regional analgesia for inguinal hernia repair in children has attracted increasing interest and different techniques like Caudal block, lumbar epidural block, wound infiltration, Ilio-inguinal nerve block and paravertebral block have been used with varying success. Read more about this study
- Who is it for?
- Ages 2 to 6 years
- Conditions the study is for
- Inguinal Hernia, Pediatric
- What is being tested?
- General anaesthesia, Ultrasound-guided RLB and Ultrasound-guided INB
- 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
- 17 May 2020to 20 Nov 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 2 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • American Society of Anesthesiologists (ASA) status: 1 or 2 .
- Unilateral inguinal hernia
Who cannot join
- •spinal abnormality
- bilateral inguinal hernia repair
- Bleeding or coagulation diathesis.
- History of known sensitivity to the used anesthetics.
- Parental refusal of consent.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura university children hospital
Al Mansurah
Mahmoud M Alseoudy, MD, 01006224551, drs3ody.mansoura@yahoo.com
About this study
Official title: Ultrasound Guided Retrolaminar Block Versus Ilioinguinal Nerve Block for Surgery of Inguinal Hernia in Children
Regional analgesia for inguinal hernia repair in children has attracted increasing interest and different techniques like Caudal block, lumbar epidural block, wound infiltration, Ilio-inguinal nerve block and paravertebral block have been used with varying success. Ilio-inguinal nerve blockade has been widely used in this context but the duration of the block is also limited to the early postoperative period. Paravertebral blockade has been shown to produce long lasting postoperative analgesia when used in combination with general anaesthesia in paediatric herniorrhaphy . Ultrasound-guided retrolaminar block is one of the newer and technically simpler alternatives to the traditional PV block . The aim of this study is to test the efficacy and safety of ultrasound guided retrolaminar block(RLB) as an analgesic technique in surgery of pediatric inguinal hernia in comparison with with ilioinguinal nerve block(INB). It is hypothesized that RLB block will provide longer duration of postoperative analgesia than INB with few side effects.
Read the detailed description
Regional analgesia for inguinal hernia repair in children has attracted increasing interest over the past few years. Caudal block, lumbar epidural block and wound infiltration using a variety of local anesthetic drugs and adjuncts have been used with varying success. Ilio-inguinal nerve blockade has been widely used in this context and despite being generally safe, complications may occurr. The duration of ilio-inguinal nerve block is also limited to the early postoperative period. Paravertebral blockade has been shown to produce long lasting postoperative analgesia when used in combination with general anaesthesia in paediatric herniorrhaphy, and has also been proposed as an alternative to general anaesthesia in adult inguinal hernia repair. Ultrasound-guided retrolaminar block is one of the newer and technically simpler alternatives to the traditional PV block. The first case report of a landmark lamina technique was followed by a study in mastectomy patients where this "blind" technique was used to inject local anesthetic between the thoracic laminae and the deep paraspinous muscles. This technique would logically decrease the chances of pleural injury, while the risk of inadvertent neuraxial injection remains. ultrasound guidance has improved the lamina technique, defining the site of injection as "retrolaminar" by real-time sonographic identification of the lamina and the needle tip-lamina contact, thus minimizing the risk of epidural injection associated with the blind technique. This was immediately followed by a report by the same group describing their first experiences with the retrolaminar technique in patients with multiple rib fractures.To our knowledge, no studies have demonstrated the efficacy and safety of ultrasound guided retro-laminar block in pediatric patients. Therefore, this study will be conducted to evaluate the efficacy and safety of retrolaminar block and compare it with the ilioinguinal nerve block in pediatric patients undergoing unilateral inguinal hernia repair. The study will include 60 patients who will be scheduled for elective outpatient inguinal herniorrhaphy. Patients will be randomly allocated using computer generated random numbers to one of two treatment groups: ultrasound guided ilio-inguinal nerve block (INB Group, n =30) or ultrasound guided retrolaminar block (RLB Group, n =30) using the sealed opaque envelope technique. The eligible patients for this study will be preoperatively evaluated regarding their medical history, clinical examination, laboratory results (complete blood picture, coagulation profile). The day before the surgery, the study protocol will be explained to parents of all patients in the study who will be kept fasting prior to surgery. General anaesthesia will be induced with 8% sevoflurane in oxygen via a facemask. After establishing venous access, a laryngeal mask will be placed and anaesthesia was maintained with 1 MAC sevoflurane and oxygen. Intraoperative monitoring included ECG, heart rate, pulse oximetry, non-invasive blood pressure and end tidal carbon dioxide concentration.During the operation, any haemodynamic changes in excess of 15% from baseline values resulted in a step-wise increase or decrease of the sevoflurane concentration. 0.3 ml.kg of 0.25% bupivacaine will be injected at the level of L1 lamina in RLB group. 0.3 ml.kg of 0.25% bupivacaine will be injected between the transversus abdominis and internal oblique toward the ilioinguinal nerve in INB group. Systolic blood pressure and heart rate will be recorded immediately prior to skin incision (baseline), 60 s after skin incision, during sac traction and on closure of the wound. Pain levels will be assessed post operatively using FLACC (face, legs, activity, cry, consolability) scale at 30 minutes and at 1, 2, 4, 6, 12, 24 hours by trained nurses and second anesthesist who will be blinded to group allocation. When the FLACC score is more than 2 and less than or equal to 5, 15 mg/kg acetaminophen IV will be administered. When the FLACC score is more than 5, 0.5μg/kg fentanyl IV will be coadministered with acetaminophen in the recovery room. Parents will be informed about the pain evaluation, and when patients have pain at home, parents will give 7 mg/kg oral ibuprofen. The anesthesiologist will record data received from the parents over the phone. Parental satisfaction after surgery will be recorded. Satisfaction levels of the parents will be given verbally as a level from 1 to 10, with the lowest level of satisfaction at a value of 1 and the highest level at 10.
- Conditions
- Inguinal Hernia, Pediatric
- Being tested
- General anaesthesia, Ultrasound-guided RLB, Ultrasound-guided INB, Bupivacaine
- Keywords
- Retrolaminar block, Ilioinguinal 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.
General anaesthesiaProcedure or surgery
General anaesthesia will be induced with 8% sevoflurane in oxygen and maintained with 1 MAC sevoflurane via a laryngeal mask.
Ultrasound-guided RLBProcedure or surgery
The suggested ultrasound transducer orientation is sagittal paramedian (cephalacaudad direction). We begin our ultrasound scanning in a paramedian sagittal plane by finding desired level (T12- L1).The transverse process view, the costotransverse ligament can be visualized above the paravertebral space. Continuing to scan from lateral to medial, the vertebral laminae come into view.
Ultrasound-guided INBProcedure or surgery
A high-frequency probe is placed medial to the anterior superior iliac spine with the axis facing the umbilicus. A needle is inserted toward the ilioinguinal nerve as it runs between the transversus abdominis and internal oblique.
BupivacaineDrug
0.3 ml.kg of 0.25% bupivacaine will be injected under visualization.
| Study group | Role | What they receive |
|---|---|---|
| Retrolamianar block (RLB) | Active comparator | General anaesthesia will be induced.Ultrasound-guided RLB will be performed under strict aseptic precautions with patient in the lateral position.The anesthetic solution will be injected. Receives: Procedure: General anaesthesia; Procedure: Ultrasound-guided RLB; Drug: Bupivacaine |
| Ilioinguinal nerve block (INB) | Active comparator | General anaesthesia will be induced. Ultrasound-guided INB will be performed under strict aseptic precautions with patient in the supine position.The anesthetic solution will be injected. Receives: Procedure: General anaesthesia; Procedure: Ultrasound-guided INB; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
First analgesic request
The time of the first analgesic request will be recorded.
Measured: [Time Frame: Up to 24 hours after the procedure]
Secondary outcomes (5)
Improvement in pain score
Pain levels will be assessed post operatively using FLACC (face, legs, activity, cry, consolability) scale at 30 minutes and at 1, 2, 4, 6, 12, 24 hours
Measured: [Time Frame: Up to 24 hours after the procedure]
Levels of parental satisfaction after surgery
Satisfaction levels of the parents will be given verbally as a level from 1 to 10, with the lowest level of satisfaction at a value of 1 and the highest level at 10
Measured: .[Time Frame: Up to 24hours after the procedure]
Incidence of adverse effects
nausea, vomiting, hematoma, or allergic reactions will be recorded
Measured: [Time Frame: Up to 24 hours after the procedure]
Changes in heart rate
heart rate will be recorded immediately prior to skin incision (baseline), 60 s after skin incision, during sac traction and on closure of the wound
Measured: [Time Frame: Up to 24 hours after the procedure]
Changes in systolic blood pressure
Systolic blood pressure will be recorded immediately prior to skin incision (baseline), 60 s after skin incision, during sac traction and on closure of the wound
Measured: [Time Frame: Up to 24 hours after the procedure]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start17 May 2020
- Primary completion15 Oct 2020 (estimated)
- Study completion20 Nov 2020 (estimated)
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.
- 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
- Model description
- Prospective, randomized, double blind study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmoud Mohammed Alseoudy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Mohammed Alseoudy, Mansoura University
- Investigators
- Mahmoud M Alseoudy, MD, Principal investigator, Faculty of Medicine, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266132
- Sponsor's protocol ID
- R.20.01.718
- Status last verified
- May 2020
- First submitted
- 10 Feb 2020
- Last updated
- 19 May 2020
- Results posted
- No
- 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 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Retrolaminar Block Versus Ilioinguinal Nerve Block for Surgery of Inguinal Hernia in Children
- ClinicalTrials.gov ID
- NCT04266132
- Acronym / sponsor ID
- R.20.01.718
- Conditions
- Inguinal Hernia, Pediatric
- Keywords
- Retrolaminar block, Ilioinguinal nerve block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mahmoud Mohammed AlseoudyUniversity, hospital or other
- Study start
- 17 May 2020 (actual)
- Primary completion
- 15 Oct 2020 (estimated)
- Study completion
- 20 Nov 2020 (estimated)
- First posted
- 12 Feb 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.
Regional analgesia for inguinal hernia repair in children has attracted increasing interest and different techniques like Caudal block, lumbar epidural block, wound infiltration, Ilio-inguinal nerve block and paravertebral block have been used with varying success. Ilio-inguinal nerve blockade has been widely used in this context but the duration of the block is also limited to the early postoperative period. Paravertebral blockade has been shown to produce long lasting postoperative analgesia when used in combination with general anaesthesia in paediatric herniorrhaphy . Ultrasound-guided retrolaminar block is one of the newer and technically simpler alternatives to the traditional PV block . The aim of this study is to test the efficacy and safety of ultrasound guided retrolaminar block(RLB) as an analgesic technique in surgery of pediatric inguinal hernia in comparison with with ilioinguinal nerve block(INB). It is hypothesized that RLB block will provide longer duration of postoperative analgesia than INB with few side effects.
Detailed description
Regional analgesia for inguinal hernia repair in children has attracted increasing interest over the past few years. Caudal block, lumbar epidural block and wound infiltration using a variety of local anesthetic drugs and adjuncts have been used with varying success. Ilio-inguinal nerve blockade has been widely used in this context and despite being generally safe, complications may occurr. The duration of ilio-inguinal nerve block is also limited to the early postoperative period. Paravertebral blockade has been shown to produce long lasting postoperative analgesia when used in combination with general anaesthesia in paediatric herniorrhaphy, and has also been proposed as an alternative to general anaesthesia in adult inguinal hernia repair. Ultrasound-guided retrolaminar block is one of the newer and technically simpler alternatives to the traditional PV block. The first case report of a landmark lamina technique was followed by a study in mastectomy patients where this "blind" technique was used to inject local anesthetic between the thoracic laminae and the deep paraspinous muscles. This technique would logically decrease the chances of pleural injury, while the risk of inadvertent neuraxial injection remains. ultrasound guidance has improved the lamina technique, defining the site of injection as "retrolaminar" by real-time sonographic identification of the lamina and the needle tip-lamina contact, thus minimizing the risk of epidural injection associated with the blind technique. This was immediately followed by a report by the same group describing their first experiences with the retrolaminar technique in patients with multiple rib fractures.To our knowledge, no studies have demonstrated the efficacy and safety of ultrasound guided retro-laminar block in pediatric patients. Therefore, this study will be conducted to evaluate the efficacy and safety of retrolaminar block and compare it with the ilioinguinal nerve block in pediatric patients undergoing unilateral inguinal hernia repair. The study will include 60 patients who will be scheduled for elective outpatient inguinal herniorrhaphy. Patients will be randomly allocated using computer generated random numbers to one of two treatment groups: ultrasound guided ilio-inguinal nerve block (INB Group, n =30) or ultrasound guided retrolaminar block (RLB Group, n =30) using the sealed opaque envelope technique. The eligible patients for this study will be preoperatively evaluated regarding their medical history, clinical examination, laboratory results (complete blood picture, coagulation profile). The day before the surgery, the study protocol will be explained to parents of all patients in the study who will be kept fasting prior to surgery. General anaesthesia will be induced with 8% sevoflurane in oxygen via a facemask. After establishing venous access, a laryngeal mask will be placed and anaesthesia was maintained with 1 MAC sevoflurane and oxygen. Intraoperative monitoring included ECG, heart rate, pulse oximetry, non-invasive blood pressure and end tidal carbon dioxide concentration.During the operation, any haemodynamic changes in excess of 15% from baseline values resulted in a step-wise increase or decrease of the sevoflurane concentration. 0.3 ml.kg of 0.25% bupivacaine will be injected at the level of L1 lamina in RLB group. 0.3 ml.kg of 0.25% bupivacaine will be injected between the transversus abdominis and internal oblique toward the ilioinguinal nerve in INB group. Systolic blood pressure and heart rate will be recorded immediately prior to skin incision (baseline), 60 s after skin incision, during sac traction and on closure of the wound. Pain levels will be assessed post operatively using FLACC (face, legs, activity, cry, consolability) scale at 30 minutes and at 1, 2, 4, 6, 12, 24 hours by trained nurses and second anesthesist who will be blinded to group allocation. When the FLACC score is more than 2 and less than or equal to 5, 15 mg/kg acetaminophen IV will be administered. When the FLACC score is more than 5, 0.5μg/kg fentanyl IV will be coadministered with acetaminophen in the recovery room. Parents will be informed about the pain evaluation, and when patients have pain at home, parents will give 7 mg/kg oral ibuprofen. The anesthesiologist will record data received from the parents over the phone. Parental satisfaction after surgery will be recorded. Satisfaction levels of the parents will be given verbally as a level from 1 to 10, with the lowest level of satisfaction at a value of 1 and the highest level at 10.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, double blind study
| Arm | Type | Receives |
|---|---|---|
| Retrolamianar block (RLB) | Active comparator | Procedure: General anaesthesia, Procedure: Ultrasound-guided RLB, Drug: BupivacaineGeneral anaesthesia will be induced.Ultrasound-guided RLB will be performed under strict aseptic precautions with patient in the lateral position.The anesthetic solution will be injected. |
| Ilioinguinal nerve block (INB) | Active comparator | Procedure: General anaesthesia, Procedure: Ultrasound-guided INB, Drug: BupivacaineGeneral anaesthesia will be induced. Ultrasound-guided INB will be performed under strict aseptic precautions with patient in the supine position.The anesthetic solution will be injected. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- • American Society of Anesthesiologists (ASA) status: 1 or 2 .
Key exclusion criteria (5 listed)
- •spinal abnormality
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 |
|---|---|---|
| General anaesthesiaGeneral anaesthesia will be induced with 8% sevoflurane in oxygen and maintained with 1 MAC sevoflurane via a laryngeal mask. | Procedure or surgery | Ilioinguinal nerve block (INB), Retrolamianar block (RLB) |
| Ultrasound-guided RLBThe suggested ultrasound transducer orientation is sagittal paramedian (cephalacaudad direction). We begin our ultrasound scanning in a paramedian sagittal plane by finding desired level (T12- L1).The transverse process view, the costotransverse ligament can be visualized above the paravertebral space. Continuing to scan from lateral to medial, the vertebral laminae come into view. | Procedure or surgery | Retrolamianar block (RLB) |
| Ultrasound-guided INBA high-frequency probe is placed medial to the anterior superior iliac spine with the axis facing the umbilicus. A needle is inserted toward the ilioinguinal nerve as it runs between the transversus abdominis and internal oblique. | Procedure or surgery | Ilioinguinal nerve block (INB) |
| Bupivacaine0.3 ml.kg of 0.25% bupivacaine will be injected under visualization. | Drug | Ilioinguinal nerve block (INB), Retrolamianar block (RLB) |
Primary outcome
First analgesic request
Time frame: [Time Frame: Up to 24 hours after the procedure]
The time of the first analgesic request will be recorded.
5 secondary outcomes
Improvement in pain score
Time frame: [Time Frame: Up to 24 hours after the procedure]
Levels of parental satisfaction after surgery
Time frame: .[Time Frame: Up to 24hours after the procedure]
Incidence of adverse effects
Time frame: [Time Frame: Up to 24 hours after the procedure]
Changes in heart rate
Time frame: [Time Frame: Up to 24 hours after the procedure]
Changes in systolic blood pressure
Time frame: [Time Frame: Up to 24 hours after the procedure]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- 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.
Mahmoud M Alseoudy, MD principal investigator
Faculty of Medicine, Mansoura 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 General anaesthesia, Ultrasound-guided RLB and Ultrasound-guided INB in people with Inguinal Hernia and Pediatric, run by Mahmoud Mohammed Alseoudy 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 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: status not confirmed, as of the sponsor's last update on 19 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud M Alseoudy, MD (+201006224551, drs3ody.mansora@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First analgesic request (time frame: [Time Frame: Up to 24 hours after the procedure]). 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 May 2020.