Postoperative Pain
Conditions
Keywords
general anesthesia, caudal block, pain, hemodynamic parameters
Brief summary
This is a prospective, randomized, controlled clinical study designed to determine the effectiveness of caudal block combined with general anesthesia in providing intra- and postoperative analgesia, and its effect on hemodynamic stability and drug consumption.
Detailed description
This prospective, randomized, controlled clinical study will include 70 boys aged 3-5 years scheduled for inguinal herniorrhaphy. Participants will be randomized in 1:1 ratio into two groups. The first group will receive general anesthesia for surgery, while the second group will receive general anesthesia in combination with caudal block. Postoperative pain, hemodynamic parameters and total consumption of all medicaments in the perioperative period will be monitored. Complications and side effects of drugs will be observed as well.
Interventions
DRUGCaudal block with levobupivacaine
After the introduction of general anesthesia, a single shot caudal block will be performed with levobupivacaine 0.25% (2.5 mg/kg; maximal dose 75 mg).
DRUGGeneral anesthesia
On the day of operation all patients will recieve midazolam 0.5 mg/kg (maximum dose 15 mg) orally. Induction of anesthesia will be the same for all patients and consist of intravenous anesthetic propofol (2-3 mg/kg), opioid analgesic fentanyl (1-1.5 mcg/kg), and muscle relaxant rocuronium - bromide (0.6-1 mg/kg). The airway will be obtained by placing a laryngeal mask (I-gel®).
PROCEDUREInguinal hernioplasty
Elective inguinal hernioplasty
Sponsors
University of Novi Sad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
3 Years to 5 Years
Healthy volunteers
No
Inclusion criteria
* boys between 3 to 5 years old * scheduled for elective inguinal hernioplasty * without comorbidities and chronic therapy, ASA class I * body mass and growth normal for the given age * no allergies * no congenital anomalies and birth complications
Exclusion criteria
* emergency surgeries * surgeries longer than 60 minutes * acute infections with leucocytosis/leucopenia * acute or chronic diseases * deformities and disorders of spine and nervous system * allergies * pilonidal cyst and/or inflammation in sacral region
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 5 hours | Postoperative pain level measured using the visual analog scale (VAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | 5 hours | Noninvasive measurement of systolic and diastolic blood pressure |
| Heart rate | 5 hours | Heart rate measured with electrocardiogram |
Countries
Serbia
Outcome results
None listed