Chordee, Hypospadias, Penile Torsion, Phimosis
Conditions
Keywords
caudal block, pudendal block, regional anesthesia
Brief summary
This study will compare two techniques to minimize pain during and after penile surgery in children undergoing certain urologic surgeries. These two approaches include the caudal nerve block and the pudendal nerve block.
Interventions
PROCEDURECaudal Block
Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine into caudal spinal space. First attempt will be landmark-guided into the caudal spine region. Subsequent attempt(s) may be done using ultrasound.
PROCEDUREUltrasound-guided Pudendal Block
Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine. Ultrasound-guided injection into each pudendal nerve region through skin of buttocks.
DRUGInjectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine
Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine into caudal spinal space. First attempt will be landmark-guided into the caudal spine region. Subsequent attempt(s) may be done using ultrasound.
DRUGInjection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine.
Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine. Ultrasound-guided injection into each pudendal nerve region through skin of buttocks.
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
6 Months to 3 Years
Healthy volunteers
No
Inclusion criteria
* Undergoing penile genitourinary surgery * ASA class 1-3
Exclusion criteria
* Female patients * Male children \<6 months or \>/= 3 years of age * ASA class \>3 * Surgery at satellite location (non-Prentiss) * Concurrent non-lower GU tract surgery * Sacrospinal abnormality * History of chronic pain requiring opioid analgesics * Inability to tolerate and receive acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), alpha-2 agonists, or local anesthetics * History of malignant hyperthermia * History of coagulopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rescue Narcotic Administration | During post-operative in-hospital recovery, approximately 1 hour | Dose (mg) of postoperative rescue opioid |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-Narcotic Rescue Administration at 24 hours | During first day after surgery, approximately 24 hours | Dose (mg) of non-narcotic rescue medication |
| Non-Narcotic Rescue Administration at 48 hours | During second day after surgery, approximately 48 hours | Dose (mg) of non-narcotic rescue medication |
| Non-Narcotic Rescue Administration at 72 hours | During third day after surgery, approximately 72 hours | Dose (mg) of non-narcotic rescue medication |
| Number of participants with at least one adverse event (AE) as measured by patient report | End of study, up to 3 months | Adverse events will include any AE related to study procedure |
Countries
United States
Outcome results
None listed