Post Operative Pain, Acute
Conditions
Brief summary
Despite the growing interest in interfascial blocks and their successful use in pediatric surgeries, no previous randomized clinical trials have directly compared the analgesic efficacy, opioid-sparing effect, and safety profile of the fascia transversalis block versus the caudal block in pediatric patients undergoing unilateral inguinal hernia repair. This study aims to address this gap by providing the first head-to-head randomized comparison between both blocks in a standardized surgical setting
Interventions
PROCEDURECaudal Block Anesthesia
Patients will receive a caudal block with 0.5 mL/kg of Bupivacaine 0.25% injected. The commercial preparation that will be used is Bupivacaine HCl (Sunny Pharmaceutical, Egypt)
PROCEDUREFascia Transversalis Block
Patients will receive Fascia Transversalis Block using 0.5 mL/kg of Bupivacaine 0.25% . The commercial preparation that will be used is Bupivacaine HCl (Sunny Pharmaceutical, Egypt)
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No
Inclusion criteria
* ASA physical status I or II, scheduled for elective unilateral inguinal hernia surgery under general anesthesia
Exclusion criteria
* Parental refusal. * Pre-existing infection at block site. * Coagulopathy (defined as INR \>1.5, Platelets \<100,000). * Known allergy to local anesthetics. * History of complications from regional anesthesia. * Emergency or bilateral hernia repair. * Neurodevelopmental disorders (e.g., cerebral palsy, spina bifida).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to the first request for rescue analgesia | 24 hours post-operatively | the interval between the end of surgery (extubation) and the first need for analgesia (paracetamol) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total intraoperative fentanyl consumption | from the start of general anesthesia until the extubation | — |
| Postoperative FLACC (Face, Legs, Activity, Cry, Consolability) pain scores | 24 hours postoperatively | Each of the five behaviors will be scored on a scale of 0 to 2. The scores are then added together to get a total score, which can range from 0 (no pain) to 10 (severe pain). |
| Total paracetamol dose in 24 hours | 24 hours postoperatively | — |
| Parental satisfaction score | 24 hours postoperatively | Will be measured using a 5-point Likert scale: 1. = Extremely dissatisfied 2. = Unsatisfied 3. = Neutral 4. = Satisfied 5. = Extremely satisfied |
Contacts
Primary ContactAbdelKhalek Shaban
Outcome results
None listed