NCT03496740

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

April 15, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 23, 2018

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

7 months

First QC Date

April 5, 2018

Last Update Submit

November 23, 2018

Conditions

Postoperative Pain

Keywords

Postoperative painUltrasoundDorsal Penile Nerve BlockPudendal BlockHypospadias

Outcome Measures

Primary Outcomes (1)

  • Time to first analgesic

    First need for rescue analgesic after the surgery will be recorded

    postoperative 7 day

Secondary Outcomes (1)

  • Pain Scores

    postoperative 48 hour

Study Arms (2)

Penile Block

ACTIVE COMPARATOR

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

Procedure: Penile BlockDrug: Bupivacaine (Block Drug)

Pudendal Block

ACTIVE COMPARATOR

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

Procedure: Pudendal BlockDrug: Bupivacaine (Block Drug)

Interventions

Penile BlockPROCEDURE

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)

Penile Block
Pudendal BlockPROCEDURE

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)

Pudendal Block
Bupivacaine (Block Drug)DRUG

Block drug

Penile BlockPudendal Block

Eligibility Criteria

Age1 Year - 10 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale patients undergoing elective hypospadias surgery
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli University Hospital

İzmit, Kocaeli, 41340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeHypospadias

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPenile DiseasesGenital Diseases, MaleGenital DiseasesMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 5, 2018

First Posted

April 12, 2018

Study Start

April 15, 2018

Primary Completion

November 23, 2018

Study Completion

November 23, 2018

Last Updated

November 27, 2018

Record last verified: 2018-11

Locations

TU(1)