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PI leaving institution
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caudal Block | Active Comparator | Patients will receive a caudal block prior to surgery. |
|
| Pudendal Block | Experimental | Patients will receive a pudendal block prior to surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caudal Block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue Narcotic Administration | Dose (mg) of postoperative rescue opioid | During post-operative in-hospital recovery, approximately 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Non-Narcotic Rescue Administration at 24 hours | Dose (mg) of non-narcotic rescue medication | During first day after surgery, approximately 24 hours |
| Non-Narcotic Rescue Administration at 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica H Hannick, MD, MSc | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30795645 | Background | Wren AA, Ross AC, D'Souza G, Almgren C, Feinstein A, Marshall A, Golianu B. Multidisciplinary Pain Management for Pediatric Patients with Acute and Chronic Pain: A Foundational Treatment Approach When Prescribing Opioids. Children (Basel). 2019 Feb 21;6(2):33. doi: 10.3390/children6020033. | |
| 31415045 | Background |
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| Ultrasound-guided Pudendal Block | Procedure | 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. |
|
| Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine | Drug | 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. |
|
| Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine. | Drug | 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. |
|
Dose (mg) of non-narcotic rescue medication
| During second day after surgery, approximately 48 hours |
| Non-Narcotic Rescue Administration at 72 hours | Dose (mg) of non-narcotic rescue medication | During third day after surgery, approximately 72 hours |
| Number of participants with at least one adverse event (AE) as measured by patient report | Adverse events will include any AE related to study procedure | End of study, up to 3 months |
| Vargas A, Sawardekar A, Suresh S. Updates on pediatric regional anesthesia safety data. Curr Opin Anaesthesiol. 2019 Oct;32(5):649-652. doi: 10.1097/ACO.0000000000000768. |
| 30857607 | Background | Wiegele M, Marhofer P, Lonnqvist PA. Caudal epidural blocks in paediatric patients: a review and practical considerations. Br J Anaesth. 2019 Apr;122(4):509-517. doi: 10.1016/j.bja.2018.11.030. Epub 2019 Feb 1. |
| 32819811 | Background | Okoro C, Huang H, Cannon S, Low D, Liston DE, Richards MJ, Lendvay TS. The pudendal nerve block for ambulatory urology: What's old is new again. A quality improvement project. J Pediatr Urol. 2020 Oct;16(5):594.e1-594.e7. doi: 10.1016/j.jpurol.2020.07.025. Epub 2020 Jul 24. |
| 33452203 | Background | Shah UJ, Nguyen D, Karuppiaah N, Martin J, Sehmbi H. Efficacy and safety of caudal dexmedetomidine in pediatric infra-umbilical surgery: a meta-analysis and trial-sequential analysis of randomized controlled trials. Reg Anesth Pain Med. 2021 May;46(5):422-432. doi: 10.1136/rapm-2020-102024. Epub 2021 Jan 15. |
| 29205687 | Background | Gaudet-Ferrand I, De La Arena P, Bringuier S, Raux O, Hertz L, Kalfa N, Sola C, Dadure C. Ultrasound-guided pudendal nerve block in children: A new technique of ultrasound-guided transperineal approach. Paediatr Anaesth. 2018 Jan;28(1):53-58. doi: 10.1111/pan.13286. Epub 2017 Dec 5. |
| 27501015 | Background | Kendigelen P, Tutuncu AC, Emre S, Altindas F, Kaya G. Pudendal Versus Caudal Block in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):610-5. doi: 10.1097/AAP.0000000000000447. |
| 24257391 | Background | Naja ZM, Ziade FM, Kamel R, El-Kayali S, Daoud N, El-Rajab MA. The effectiveness of pudendal nerve block versus caudal block anesthesia for hypospadias in children. Anesth Analg. 2013 Dec;117(6):1401-7. doi: 10.1213/ANE.0b013e3182a8ee52. |
| ID | Term |
|---|---|
| D007021 | Hypospadias |
| D010688 | Phimosis |
| ID | Term |
|---|---|
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| 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 |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D000077212 | Ropivacaine |
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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