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The purpose of this randomized blinded prospective study is to compare the analgesic efficacy and duration of a Pudendal Nerve Block (PNB) to a Caudal Block (CB) for pediatric patients, ages 6 months to 2 years, undergoing hypospadias repair.
Hypospadias repair is one of the most common congenital malformations of the penis in the United States. It has an incidence of about 1 in 300 births. A combination of general anesthesia and a caudal block or general anesthesia combined with a pudendal nerve block are commonly used for hypospadias repair.
In our institution, hypospadias repair is typically done in infants and children ages 6 months to age two. A comparison of the efficacy of pudendal block versus the caudal block has not been undertaken in this younger population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral Pudendal block | Experimental | 0.25 cc per kg of 0.2% ropivacaine will be injected once for right pudendal N block and the same volume for the left pudendal N block before the start of the surgery |
|
| Caudal block | Active Comparator | 1 cc per kg of 0.2% ropivacaine in the caudal space given before the start of surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caudal block | Procedure | 1 cc per kg of 0.2% ropivicaine in the caudal space given before the start of surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid consumption | The child's care giver will document the times that a rescue opioid was given to relieve pain. | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative block assessment | A heart rate increase above of 20 percent of baseline will be an indication of inadequate block that will be treated with a rescue opioid. | up to 3 hours |
| Post operative pain |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nemours/ duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36283712 | Derived | Choudhry DK, Heredia L, Brenn BR, Brown M, Carvalho NF, Whaley MC, Shaik SS, Hagerty JA, Bani Hani A. Nerve stimulation guided bilateral pudendal nerve block versus landmark-based caudal block for hypospadias repair in young children: a prospective, randomized, pragmatic trial. Reg Anesth Pain Med. 2022 Dec;47(12):744-748. doi: 10.1136/rapm-2022-103680. Epub 2022 Sep 8. |
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| ID | Term |
|---|---|
| D007021 | Hypospadias |
| D004842 | Epispadias |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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All Children will be randomly assigned to one of 2 groups of 30 patients each using a computer generated number table.
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No other parties will be masked.
| Bilateral Pudendal block | Procedure | 0.5 cc per kg of 0.2% ropivicaine. Half of the volume given as a right pudendal block and the remaining volume given on the left pudendal nerve block given prior to the start of surgery |
|
The FLACC scale scores greater than 6 will be an indication of inadequate pain relief needing a rescue dosages of opioid.
| up to 2 hours |
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |