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Ultrasound Guided Retrolaminar Block for Pediatric Inguinal Hernia

Primary Purpose

Inguinal Hernia, Pediatric

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
General anaesthesia
Ultrasound-guided RLB
Ultrasound-guided INB
Bupivacaine
Sponsored by
Mahmoud Mohammed Alseoudy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring Retrolaminar block, Ilioinguinal nerve block

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • • American Society of Anesthesiologists (ASA) status: 1 or 2 .

    • Unilateral inguinal hernia

Exclusion Criteria:

  • •spinal abnormality

    • bilateral inguinal hernia repair
    • Bleeding or coagulation diathesis.
    • History of known sensitivity to the used anesthetics.
    • Parental refusal of consent.

Sites / Locations

  • Mansoura university children hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Retrolamianar block (RLB)

Ilioinguinal nerve block (INB)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

First analgesic request
The time of the first analgesic request will be recorded.

Secondary Outcome Measures

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
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
Incidence of adverse effects
nausea, vomiting, hematoma, or allergic reactions will be recorded
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
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

Full Information

First Posted
February 10, 2020
Last Updated
May 17, 2020
Sponsor
Mahmoud Mohammed Alseoudy
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1. Study Identification

Unique Protocol Identification Number
NCT04266132
Brief Title
Ultrasound Guided Retrolaminar Block for Pediatric Inguinal Hernia
Official Title
Ultrasound Guided Retrolaminar Block Versus Ilioinguinal Nerve Block for Surgery of Inguinal Hernia in Children
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 17, 2020 (Actual)
Primary Completion Date
October 15, 2020 (Anticipated)
Study Completion Date
November 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mahmoud Mohammed Alseoudy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Pediatric
Keywords
Retrolaminar block, Ilioinguinal nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, double blind study
Masking
ParticipantOutcomes Assessor
Masking Description
Double (Participant, Outcomes Assessor)The study subjects and the resident assessing the outcomes will be blinded to the study group. A single investigator will assess the patients for eligibility, obtain written informed consent, open the sealed opaque envelopes containing group allocation, perform the block, and administer bupivacaine solution.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Retrolamianar block (RLB)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ilioinguinal nerve block (INB)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
General anaesthesia
Intervention Description
General anaesthesia will be induced with 8% sevoflurane in oxygen and maintained with 1 MAC sevoflurane via a laryngeal mask.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided RLB
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided INB
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
0.3 ml.kg of 0.25% bupivacaine will be injected under visualization.
Primary Outcome Measure Information:
Title
First analgesic request
Description
The time of the first analgesic request will be recorded.
Time Frame
[Time Frame: Up to 24 hours after the procedure]
Secondary Outcome Measure Information:
Title
Improvement in pain score
Description
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
Time Frame
[Time Frame: Up to 24 hours after the procedure]
Title
Levels of parental satisfaction after surgery
Description
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
Time Frame
.[Time Frame: Up to 24hours after the procedure]
Title
Incidence of adverse effects
Description
nausea, vomiting, hematoma, or allergic reactions will be recorded
Time Frame
[Time Frame: Up to 24 hours after the procedure]
Title
Changes in heart rate
Description
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
Time Frame
[Time Frame: Up to 24 hours after the procedure]
Title
Changes in systolic blood pressure
Description
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
Time Frame
[Time Frame: Up to 24 hours after the procedure]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • American Society of Anesthesiologists (ASA) status: 1 or 2 . Unilateral inguinal hernia Exclusion Criteria: •spinal abnormality bilateral inguinal hernia repair Bleeding or coagulation diathesis. History of known sensitivity to the used anesthetics. Parental refusal of consent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud M Alseoudy, MD
Phone
+201006224551
Email
drs3ody.mansora@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud M Alseoudy, MD
Organizational Affiliation
Faculty of Medicine, Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university children hospital
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud M Alseoudy, MD
Phone
01006224551
Email
drs3ody.mansoura@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Ultrasound Guided Retrolaminar Block for Pediatric Inguinal Hernia

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