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Ultrasound Guided Penile Block vs Pudendal Block for Hypospadias

Primary Purpose

Postoperative Pain

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Penile Block

Pudendal Block

Bupivacaine (Block Drug)

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Postoperative pain, Ultrasound, Dorsal Penile Nerve Block, Pudendal Block, Hypospadias

Eligibility Criteria

1 Year - 10 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

1 to 10 years of age
ASA I-II
Undergoing elective hypospadias surgery

Exclusion Criteria:

infection of the skin at the site of needle puncture area
patients with known allergies to any of the study drugs
coagulopathy
ASA III-IV
Patients with neurological disorders

Sites / Locations

Kocaeli University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Penile Block

Pudendal Block

Arm Description

Ultrasound guided dorsal penile nerve block will be administered after general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml) will be used for the blocks

Nerve stimulator-guided pudendal block. 0,25% Bupivacaine 0,5ml/kg (max. 20ml) will be used for the blocks

Outcomes

Primary Outcome Measures

Time to first analgesic

First need for rescue analgesic after the surgery will be recorded

Secondary Outcome Measures

Pain Scores

FLACC scale will be used. The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.

Full Information

NCT ID

NCT03496740

First Posted

April 5, 2018

Last Updated

November 23, 2018

Sponsor

Kirsehir Ahi Evran University

1. Study Identification

Unique Protocol Identification Number

NCT03496740

Brief Title

Ultrasound Guided Penile Block vs Pudendal Block for Hypospadias

Official Title

Ultrasound Guided Dorsal Penile Block vs Neurostimulator Guided Pudendal Block in Children Undergoing Hypospadias Surgery: A Prospective, Randomized, Double-Blind Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

April 15, 2018 (Actual)

Primary Completion Date

November 23, 2018 (Actual)

Study Completion Date

November 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Pain after hypospadias surgery is a challenging issue to solve for anesthesists. Many different analgesia techniques were defined in literature for this purpose. The investigators have implemented application of ultrasound guided dorsal penile nerve block into practice for these type of surgeries. Main purpose of this study is to compare the efficacy of nerve stimulator guided pudendal nerve block with ultrasound guided dorsal penile nerve block for postoperative analgesia after hypospadias surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain

Keywords

Postoperative pain, Ultrasound, Dorsal Penile Nerve Block, Pudendal Block, Hypospadias

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Penile Block

Arm Type

Active Comparator

Arm Description

Ultrasound guided dorsal penile nerve block will be administered after general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml) will be used for the blocks

Arm Title

Pudendal Block

Arm Type

Active Comparator

Arm Description

Nerve stimulator-guided pudendal block. 0,25% Bupivacaine 0,5ml/kg (max. 20ml) will be used for the blocks

Intervention Type

Procedure

Intervention Name(s)

Penile Block

Intervention Description

Ultrasound guided dorsal penile nerve block will be done to this group of patients preoperatively, under general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml)

Intervention Type

Procedure

Intervention Name(s)

Pudendal Block

Intervention Description

Nerve stimulation guided bilateral pudendal block will be done to this group of patients preoperatively, under general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml)

Intervention Type

Drug

Intervention Name(s)

Bupivacaine (Block Drug)

Intervention Description

Block drug

Primary Outcome Measure Information:

Title

Time to first analgesic

Description

First need for rescue analgesic after the surgery will be recorded

Time Frame

postoperative 7 day

Secondary Outcome Measure Information:

Title

Pain Scores

Description

Time Frame

postoperative 48 hour

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

male patients undergoing elective hypospadias surgery

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 1 to 10 years of age ASA I-II Undergoing elective hypospadias surgery Exclusion Criteria: infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy ASA III-IV Patients with neurological disorders

Facility Information:

Facility Name

Kocaeli University Hospital

City

İzmit

State/Province

Kocaeli

ZIP/Postal Code

41340

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Ultrasound Guided Penile Block vs Pudendal Block for Hypospadias

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