Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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Currently, central neuraxial analgesic techniques have been replaced by ultrasoundguided interfascial plane blocks that have gained more popularity among anesthetists because they are safer, easily performed, associated with minor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 .
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mona Gad, Assist.Prof. | Department of anesthesia and SICU,Faculty of medicine,Mansoura university , Egypt. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura university Hospital | Al Mansurah | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Ilioinguinal/iliohypogastric nerve block (IINB) | Procedure | Ilioinguinal/iliohypogastric nerve block (IINB) |
|
| IINB+ Spermatic cord block | Procedure | IINB+ Spermatic cord block |
|
| ID | Term |
|---|---|
| D006552 | Hernia, Inguinal |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
Not provided
Not provided