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Caudal vs. Pudendal Block in Peds GU

Primary Purpose

Hypospadias, Penile Torsion, Chordee

Status
Suspended
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Caudal Block
Ultrasound-guided Pudendal Block
Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine
Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine.
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypospadias focused on measuring caudal block, pudendal block, regional anesthesia

Eligibility Criteria

6 Months - 3 Years (Child)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UH Rainbow Babies and Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Caudal Block

Pudendal Block

Arm Description

Patients will receive a caudal block prior to surgery.

Patients will receive a pudendal block prior to surgery.

Outcomes

Primary Outcome Measures

Rescue Narcotic Administration
Dose (mg) of postoperative rescue opioid

Secondary Outcome Measures

Non-Narcotic Rescue Administration at 24 hours
Dose (mg) of non-narcotic rescue medication
Non-Narcotic Rescue Administration at 48 hours
Dose (mg) of non-narcotic rescue medication
Non-Narcotic Rescue Administration at 72 hours
Dose (mg) of non-narcotic rescue medication
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

Full Information

First Posted
January 23, 2023
Last Updated
August 30, 2023
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05708989
Brief Title
Caudal vs. Pudendal Block in Peds GU
Official Title
Caudal vs. Pudendal Block for Early Postoperative Pain Control in a Pediatric Population Undergoing Lower Genitourinary Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Suspended
Why Stopped
Transitioning to new clinic
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Cleveland Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypospadias, Penile Torsion, Chordee, Phimosis
Keywords
caudal block, pudendal block, regional anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Caudal Block
Arm Type
Active Comparator
Arm Description
Patients will receive a caudal block prior to surgery.
Arm Title
Pudendal Block
Arm Type
Experimental
Arm Description
Patients will receive a pudendal block prior to surgery.
Intervention Type
Procedure
Intervention Name(s)
Caudal Block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided Pudendal Block
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Injectable 1 ml/kg of 0.25% ropivacaine with 1mcg/kg dexmedetomidine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Injection of 0.5 ml/kg per side of injectable 0.2-0.3% ropivacaine with 0.5 mcg/kg dexmetomedine.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rescue Narcotic Administration
Description
Dose (mg) of postoperative rescue opioid
Time Frame
During post-operative in-hospital recovery, approximately 1 hour
Secondary Outcome Measure Information:
Title
Non-Narcotic Rescue Administration at 24 hours
Description
Dose (mg) of non-narcotic rescue medication
Time Frame
During first day after surgery, approximately 24 hours
Title
Non-Narcotic Rescue Administration at 48 hours
Description
Dose (mg) of non-narcotic rescue medication
Time Frame
During second day after surgery, approximately 48 hours
Title
Non-Narcotic Rescue Administration at 72 hours
Description
Dose (mg) of non-narcotic rescue medication
Time Frame
During third day after surgery, approximately 72 hours
Title
Number of participants with at least one adverse event (AE) as measured by patient report
Description
Adverse events will include any AE related to study procedure
Time Frame
End of study, up to 3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica H Hannick, MD, MSc
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30795645
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.
Results Reference
background
PubMed Identifier
31415045
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.
Results Reference
background
PubMed Identifier
30857607
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.
Results Reference
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PubMed Identifier
32819811
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.
Results Reference
background
PubMed Identifier
33452203
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.
Results Reference
background
PubMed Identifier
29205687
Citation
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.
Results Reference
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PubMed Identifier
27501015
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.
Results Reference
background
PubMed Identifier
24257391
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.
Results Reference
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Caudal vs. Pudendal Block in Peds GU

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