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Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to the Combined Therapy With Spermatic Cord Block

Primary Purpose

Hernia, Inguinal

Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Levobupivacaine
Ilioinguinal/iliohypogastric nerve block (IINB)
IINB+ Spermatic cord block
Sponsored by
Egymedicalpedia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal focused on measuring inguinal herniotomy, ilioinguinal nerve block, iliohypogastric nerve block, spermatic cord block

Eligibility Criteria

12 Months - 60 Months (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria: Male pediatric patients underwent elective open unilateral inguinal herniotomy Informed written consent will be obtained from the parents or the legal guardian. Exclusion Criteria: local infection at the puncture site, bleeding disorder, allergy to amide local anesthetics, history of clinically significant cardiac, hepatic, or renal disorders. neurological dysfunction

Sites / Locations

  • Mansoura university Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ilioinguinal/iliohypogastric nerve block (IINB)

IINB+ Spermatic cord block

Arm Description

evaluate the postoperative analgesic effects with using ultrasound-guided ilioinguinal/iliohypogastric nerve block (IINB) in children scheduled for elective open inguinal herniotomy.

evaluate the postoperative analgesic effects with using ultrasound-guided IINB + spermatic cord block (SCB) in children scheduled for elective open inguinal herniotomy.

Outcomes

Primary Outcome Measures

Rescue Analgesia
Assessment of the proportion of patients who needed rescue analgesia. Intravenous paracetamol 15mg/kg will be given as a rescue analgesic if FLACC pain scale ≥ 4
Post Operative Pain
Assessment of The pain level of the cases by (Face, Leg, Activity, Cry, Consolability) pain scale (FLACC ) means of the digital pain.

Secondary Outcome Measures

Full Information

First Posted
October 20, 2022
Last Updated
October 17, 2023
Sponsor
Egymedicalpedia
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1. Study Identification

Unique Protocol Identification Number
NCT05600296
Brief Title
Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to the Combined Therapy With Spermatic Cord Block
Official Title
Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to the Combined Therapy With Spermatic Cord Block in Inguinal Herniotomy Operation in Children: a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
May 1, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Egymedicalpedia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a single center randomized, controlled, double-blinded, noninferiority study. Male pediatric patients who underwent inguinal herniotomy will be screened for eligibility. Patients will be randomly allocated to IINB and IINB/SCB groups with allocation ratio 1:1. The primary outcome measure will be the proportion of patients who needed rescue analgesia during the first postoperative 6 h. The secondary outcome measures will be intraoperative heart rate and mean arterial blood pressure (MAP), the postoperative pain FLACC pain scale, and intravenous paracetamol consumption, the incidence of adverse effects including hematoma, postoperative vomiting and fever.
Detailed Description
Inguinal herniotomy in children is a frequent surgical procedure that require good postoperative analgesia. Ultrasound-guided ilioinguinal/iliohypogastric nerve block is a widely validated anesthetic technique for this procedureز Currently, central neuraxial analgesic techniques have been replaced by ultrasoundguided interfascial plane blocks that have gained more popularity among anesthetists because they are safer, easily performed, associated with minor hemodynamic changes and can be done in the presence of contraindications of the neuraxial block . Ultrasound-guided ilioinguinal/iliohypogastric nerve block (IINB) is commonly done in pediatric patients to control pain after lower abdominal surgeries and has been shown to be effective in controlling pain after inguinal hernia repair . However IINB don't affect the genitofemoral neve that contributes the sensory innervation of the inguinal region. The spermatic cord (SC) is a unique male structure that contains the vas deferens, testicular arteries, the pampiniform plexus of veins, and the ilioinguinal nerve and genital branch of the genitofemoral nerve (GFN). To provide complete analgesia for inguinal hernia surgery, GFN should be blocked in addition to IINB .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal
Keywords
inguinal herniotomy, ilioinguinal nerve block, iliohypogastric nerve block, spermatic cord block

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ilioinguinal/iliohypogastric nerve block (IINB)
Arm Type
Active Comparator
Arm Description
evaluate the postoperative analgesic effects with using ultrasound-guided ilioinguinal/iliohypogastric nerve block (IINB) in children scheduled for elective open inguinal herniotomy.
Arm Title
IINB+ Spermatic cord block
Arm Type
Active Comparator
Arm Description
evaluate the postoperative analgesic effects with using ultrasound-guided IINB + spermatic cord block (SCB) in children scheduled for elective open inguinal herniotomy.
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine
Intervention Description
Evaluation the postoperative analgesic effects by using ultrasound-guided spermatic cord block (SCB) and IINB in children scheduled for elective open inguinal herniotomy. The study hypothesized that, the combined block with SCB and IINB would result in more effective postoperative analgesia than the use of IINB alone.
Intervention Type
Procedure
Intervention Name(s)
Ilioinguinal/iliohypogastric nerve block (IINB)
Intervention Description
Ilioinguinal/iliohypogastric nerve block (IINB)
Intervention Type
Procedure
Intervention Name(s)
IINB+ Spermatic cord block
Intervention Description
IINB+ Spermatic cord block
Primary Outcome Measure Information:
Title
Rescue Analgesia
Description
Assessment of the proportion of patients who needed rescue analgesia. Intravenous paracetamol 15mg/kg will be given as a rescue analgesic if FLACC pain scale ≥ 4
Time Frame
From base line to 6 hours postoperatively
Title
Post Operative Pain
Description
Assessment of The pain level of the cases by (Face, Leg, Activity, Cry, Consolability) pain scale (FLACC ) means of the digital pain.
Time Frame
From base line to 6 hours postoperatively

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male pediatric patients underwent elective open unilateral inguinal herniotomy Informed written consent will be obtained from the parents or the legal guardian. Exclusion Criteria: local infection at the puncture site, bleeding disorder, allergy to amide local anesthetics, history of clinically significant cardiac, hepatic, or renal disorders. neurological dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona Gad, Assist.Prof.
Organizational Affiliation
Department of anesthesia and SICU,Faculty of medicine,Mansoura university , Egypt.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university Hospital
City
Mansoura
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ultrasound-guided Ilioinguinal/Iliohypogastric Nerve Block Compared to the Combined Therapy With Spermatic Cord Block

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