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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General anesthesia + caudal block | Experimental | General anesthesia with 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), in combination with a single shot caudal block with levobupivacaine 0.25% (2.5 mg/kg; maximal dose 75 mg). |
|
| General anesthesia | Active Comparator | General anesthesia with 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caudal block with levobupivacaine | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain | Postoperative pain level measured using the visual analog scale (VAS) | 5 hours |
| Postoperative pain | Postoperative pain level measured using the Wong-Baker Faces pain rating scale | 5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Noninvasive measurement of systolic and diastolic blood pressure | 5 hours |
| Heart rate | Heart rate measured with electrocardiogram |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute for health care of children and youth of Vojvodina | Novi Sad | Vojvodina | 21000 | Serbia |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| D000768 | Anesthesia, General |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| General anesthesia | Drug | 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®). |
|
| Inguinal hernioplasty | Procedure | Elective inguinal hernioplasty |
|
| 5 hours |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |