NCT05600296

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 31, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

6 months

First QC Date

October 20, 2022

Last Update Submit

October 17, 2023

Conditions

Hernia, Inguinal

Keywords

inguinal herniotomyilioinguinal nerve blockiliohypogastric nerve blockspermatic cord block

Outcome Measures

Primary Outcomes (2)

  • 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

    From base line to 6 hours postoperatively

  • 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.

    From base line to 6 hours postoperatively

Study Arms (2)

Ilioinguinal/iliohypogastric nerve block (IINB)

ACTIVE COMPARATOR

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

Drug: LevobupivacaineProcedure: Ilioinguinal/iliohypogastric nerve block (IINB)

IINB+ Spermatic cord block

ACTIVE COMPARATOR

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

Drug: LevobupivacaineProcedure: IINB+ Spermatic cord block

Interventions

LevobupivacaineDRUG

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.

IINB+ Spermatic cord blockIlioinguinal/iliohypogastric nerve block (IINB)
Ilioinguinal/iliohypogastric nerve block (IINB)PROCEDURE

Ilioinguinal/iliohypogastric nerve block (IINB)

Ilioinguinal/iliohypogastric nerve block (IINB)
IINB+ Spermatic cord blockPROCEDURE

IINB+ Spermatic cord block

IINB+ Spermatic cord block

Eligibility Criteria

Age12 Months - 60 Months
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male pediatric patients
  • underwent elective open unilateral inguinal herniotomy
  • Informed written consent will be obtained from the parents or the legal guardian.

You may not qualify if:

  • local infection at the puncture site,
  • bleeding disorder,
  • allergy to amide local anesthetics,
  • history of clinically significant cardiac, hepatic, or renal disorders.
  • neurological dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university Hospital

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Hernia, Inguinal

Interventions

Levobupivacaine

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Mona Gad, Assist.Prof.

    Department of anesthesia and SICU,Faculty of medicine,Mansoura university , Egypt.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 31, 2022

Study Start

November 1, 2022

Primary Completion

May 1, 2023

Study Completion

May 15, 2023

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)