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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT05708989
Other study ID # STUDY20220033
Secondary ID
Status Suspended
Phase Phase 4
First received
Last updated
Start date March 6, 2023
Est. completion date May 2025

Study information

Verified date August 2023
Source University Hospitals Cleveland Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Suspended
Enrollment 138
Est. completion date May 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender Male
Age group 6 Months to 3 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Caudal 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.
Ultrasound-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.
Drug:
Injectable 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.
Injection 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.

Locations

Country Name City State
United States UH Rainbow Babies and Children's Hospital Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Rescue Narcotic Administration Dose (mg) of postoperative rescue opioid During post-operative in-hospital recovery, approximately 1 hour
Secondary Non-Narcotic Rescue Administration at 24 hours Dose (mg) of non-narcotic rescue medication During first day after surgery, approximately 24 hours
Secondary Non-Narcotic Rescue Administration at 48 hours Dose (mg) of non-narcotic rescue medication During second day after surgery, approximately 48 hours
Secondary Non-Narcotic Rescue Administration at 72 hours Dose (mg) of non-narcotic rescue medication During third day after surgery, approximately 72 hours
Secondary 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
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