Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05600296
Other study ID # Mona Gad 2
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 1, 2022
Est. completion date May 15, 2023

Study information

Verified date October 2023
Source Egymedicalpedia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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is a widely validated anesthetic technique for this procedureز Currently, central neuraxial analgesic techniques have been replaced by ultrasoundguided interfascial plane blocks that have gained more popularity among anesthetists because they are safer, easily performed, associated with minor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 .


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date May 15, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers No
Gender Male
Age group 12 Months to 60 Months
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Levobupivacaine
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.
Procedure:
Ilioinguinal/iliohypogastric nerve block (IINB)
Ilioinguinal/iliohypogastric nerve block (IINB)
IINB+ Spermatic cord block
IINB+ Spermatic cord block

Locations

Country Name City State
Egypt Mansoura university Hospital Mansoura

Sponsors (1)

Lead Sponsor Collaborator
Egymedicalpedia

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT02975401 - Robotic Utility for Surgical Treatment of Groin Hernias N/A
Completed NCT01421602 - A Prospective Observational Study on the Use of a Self Fixating Lightweight Polyester Mesh in Open Inguinal Hernia
Recruiting NCT01830452 - Less Chronic Pain After Lichtenstein Hernioplasty Using the Self-gripping Parietex Progrip Mesh Phase 4
Completed NCT00130091 - The Addition of Clonidine to 0.2% Ropivacaine for Wound Instillation After Minor Lower Abdominal Surgery in Children Phase 2
Completed NCT03665883 - Use of Diathermy Versus Blunt Dissection in TEP for Inguinal Hernia N/A
Recruiting NCT03041948 - Evaluating Pain Outcomes of Caudal vs Ilioinguinal Nerve Block in Children Undergoing Hernia Repair N/A
Completed NCT02751190 - Chronic Pain After Groin Hernia Repair N/A
Completed NCT04839848 - Chronic Postoperative Pain After the Lichtenstein Groin Hernioplasty
Completed NCT04228536 - Chronic Pain After Groin Hernia Surgery in Women
Recruiting NCT02011698 - Absorbable Sutures , Non Absorbable Sutures or Biologic Fibrin Glue for Protesic Mesh Fixing in Lichtenstein Technique for Primitive Groin Hernia Repair: a Randomized Prospective Multicentric Trial N/A
Completed NCT00827944 - Parietex Progrip Study Phase 4
Completed NCT00749268 - AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair Phase 4
Recruiting NCT03673163 - Lidocaine Infusion for Pain After Herniotomy N/A
Terminated NCT00735124 - Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy Phase 2/Phase 3
Recruiting NCT05323552 - Hernia Repair Using the Totally ExtraPeritoneal (TEP) Laparoscopic Approach Without Curare and Without Orotracheal Intubation.
Completed NCT03326700 - Effects of Hernia Repair on Men's Sexual Functions N/A
Completed NCT02616406 - Objective Measure of Recovery After Outpatient Surgery
Recruiting NCT05839587 - Transabdominal Preperitoneal Inguinal Hernia Repair N/A
Completed NCT03392636 - Comparison of Recurrence Rate of 2 Herniotomy Techniques in Children Older Than 2 Years N/A
Recruiting NCT05280860 - Effect of Bilateral RSB on Postoperative Delirium in Elderly Patients Undergoing Laparoendoscopic Single-site Surgery N/A