Ultrasound Guided Retrolaminar Block for Pediatric Inguinal Hernia

NCT04266132 | Unknown

• 1 other identifier: R.20.01.718
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia; Pediatric

Keywords

Retrolaminar block; Ilioinguinal nerve block

Outcome Measures

Primary Outcomes (1)

• First analgesic request

  The time of the first analgesic request will be recorded.

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

Secondary Outcomes (5)

• Improvement in pain score

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

• Levels of parental satisfaction after surgery

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

• Incidence of adverse effects

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

• Changes in heart rate

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

• Changes in systolic blood pressure

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

Study Arms (2)

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.

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.

Procedure: General anaesthesia; Procedure: Ultrasound-guided INB; Drug: Bupivacaine

Interventions

General anaesthesia PROCEDURE

General anaesthesia will be induced with 8% sevoflurane in oxygen and maintained with 1 MAC sevoflurane via a laryngeal mask.

Ilioinguinal nerve block (INB); Retrolamianar block (RLB)

Ultrasound-guided RLB PROCEDURE

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.

Retrolamianar block (RLB)

Ultrasound-guided INB PROCEDURE

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.

Ilioinguinal nerve block (INB)

Bupivacaine DRUG

0.3 ml.kg of 0.25% bupivacaine will be injected under visualization.

Ilioinguinal nerve block (INB); Retrolamianar block (RLB)

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mahmoud Mohammed Alseoudy: lead

Study Sites (1)

Mansoura university children hospital

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Anesthesia, General; Bupivacaine

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Mahmoud M Alseoudy, MD

  Faculty of Medicine, Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud M Alseoudy, MD

CONTACT

+201006224551; drs3ody.mansora@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Model Details: Prospective, randomized, double blind study

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 12, 2020
• Study Start: May 17, 2020
• Primary Completion: October 15, 2020
• Study Completion: November 20, 2020
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)