Caudal vs. Pudendal Block in Peds GU

July 24, 2024 updated by: University Hospitals Cleveland Medical Center

Caudal vs. Pudendal Block for Early Postoperative Pain Control in a Pediatric Population Undergoing Lower Genitourinary Surgery

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • UH Rainbow Babies and Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 3 years (Child)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Caudal Block
Patients will receive a caudal block prior to surgery.
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.
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.
Experimental: Pudendal Block
Patients will receive a pudendal block prior to surgery.
Procedure: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rescue Narcotic Administration
Time Frame: During post-operative in-hospital recovery, approximately 1 hour
Dose (mg) of postoperative rescue opioid
During post-operative in-hospital recovery, approximately 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-Narcotic Rescue Administration at 24 hours
Time Frame: During first day after surgery, approximately 24 hours
Dose (mg) of non-narcotic rescue medication
During first day after surgery, approximately 24 hours
Non-Narcotic Rescue Administration at 48 hours
Time Frame: During second day after surgery, approximately 48 hours
Dose (mg) of non-narcotic rescue medication
During second day after surgery, approximately 48 hours
Non-Narcotic Rescue Administration at 72 hours
Time Frame: During third day after surgery, approximately 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
Time Frame: End of study, up to 3 months
Adverse events will include any AE related to study procedure
End of study, up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Investigators

  • Principal Investigator: Jessica H Hannick, MD, MSc, University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2023

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20220033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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