Analgesia
Conditions
Brief summary
Perioperative pain management in pediatric patients, especially for anorectal and penile surgeries, presents significant challenges for anesthetists. Complications associated with systemic analgesia, such as respiratory issues, cardiovascular problems, and neurological effects, can be avoided by using regional anesthesia. This study aims to evaluate the effectiveness of Ultrasound-Guided Sacral Multifidus Plane Block as a method for perioperative analgesia in high-risk pediatric patients undergoing anorectal and penile surgeries, to reduce the risks associated with systemic analgesia.
Detailed description
Effective postoperative pain control in pediatric patients remains a major concern, particularly in those undergoing anal, perineal and penile surgeries. Inadequate analgesia is associated with delayed recovery, increased stress response, prolonged hospitalisation, and higher postoperative morbidity. This study aims to evaluate the efficacy of ultrasound-guided sacral multifidus plane block as a method for perioperative analgesia in high-risk pediatric patients undergoing anorectal and penile surgeries, to reduce the risks associated with systemic analgesia. This involves the administration of local anesthetics in the plane between the sacral multifidus muscle and the intermediate sacral crest bilaterally.
Interventions
OTHERSystemic analgesia
Patients will receive 10 milligrams per kilogram body weight of intravenous paracetamol every 8 hours and fentanyl 1 microgram per kilogram body weight intravenously as rescue analgesia.
PROCEDURESacral multifidus plane block
Patients will receive an ultrasound-guided sacral multifidus plane block after induction of general anesthesia.
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
* Parents or caregivers' acceptance. * High-risk pediatric patients (the American Society of Anesthesiologists physical status class III-IV) * Body mass index equal to 5%: 85% of the same age and sex.
Exclusion criteria
* Child with a contraindication to the regional block, such as infection at the site of injection, or coagulopathy. * Pre-existing neurological disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to rescue analgesia | 24 hours | First time of additional analgesia given when the child exhibit moderate to severe pain with pain score become ≥ 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | 24 hours | The perioperative changes in heart rate basally and at time interval 10-minutes till discharge and at ward at 2,4,8,16, and 24 hours postoperative. |
| Mean arterial pressure | 24 hours | The perioperative changes in mean blood pressure basally and at time interval 10-minutes till discharge and at ward at 2,4,8,16, and 24 hours postoperative. |
| Postoperative pain score | 24 hours | Pain score will be assessed using the Face, Legs, Activity, Cry, and Consolability score immediately postoperative then at 2, 4, 8, 16 and 24 hours with a score of 0 indicates no pain and 10 indicates maximum pain. |
| Total dose of opioid consumption | 24 hours | The total dose of opioid consumption as rescue analgesia in the first 24 hours postoperative. |
| Parental satisfaction | 24 hours | Parental satisfaction will be evaluated using a five-point score at the end of the first 24 hours with a score of 5 indicate the highest satisfaction and 1 indicate the lowest satisfaction. |
Countries
Egypt
Contacts
CONTACTAbdalla Mohamed Goda Mohamed, MD
CONTACTAmira Attia Ebrahim Farag, MD
PRINCIPAL_INVESTIGATORAbdelrazek yousef, MD
Department of Pediatric surgery, Zagazig University
PRINCIPAL_INVESTIGATORMohamed Ismail Sabry, MD
Department of Pediatric surgery, Zagazig University
Outcome results
None listed