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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Mahmoud M Alseoudy, MD contact

+201006224551

drs3ody.mansora@yahoo.com

Egypt1 site, 1 recruiting
  • Mansoura university children hospital

    Al Mansurah

    Mahmoud M Alseoudy, MD, 01006224551, drs3ody.mansoura@yahoo.com

    Recruiting

Other trials in Egypt

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.

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 groups in NCT04266132
Study groupRoleWhat they receive
Retrolamianar block (RLB)Active comparatorGeneral 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 comparatorGeneral 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.

  1. 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)
  1. 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]

  2. 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]

  3. Incidence of adverse effects

    nausea, vomiting, hematoma, or allergic reactions will be recorded

    Measured: [Time Frame: Up to 24 hours after the procedure]

  4. 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]

  5. 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.

  1. First posted12 Feb 2020
  2. Study start17 May 2020
  3. Primary completion15 Oct 2020 (estimated)
  4. Study completion20 Nov 2020 (estimated)

Resources

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)
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

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.

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