NCT03258255

Brief Summary

The aim of this prospective randomized study is to assess the analgesic efficacy of Pudendal block compared with penil block for pediatric patients undergoing circumsion concerning postoperative analgesic consumption within 24 hours.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

November 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

August 20, 2017

Last Update Submit

November 15, 2017

Conditions

Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain evaluatiom

    CHEOPS pain scale

    24 hour

Study Arms (2)

Pudendal block group in circumcision

ACTIVE COMPARATOR

Nerve stimulated pudendal nerve block performed under general anesthesia

Procedure: penil or pudendal nerve block in circumcision

Penil block group in circumcision

ACTIVE COMPARATOR

Penil block performed by surgeon under general anesthesia

Procedure: penil or pudendal nerve block in circumcision

Interventions

penil or pudendal nerve block in circumcisionPROCEDURE

regional analgesia methods during the circumsion nerve stimulator guided pudendal block performed by anesthesiologist/ penil block performed by surgeon before circumcision

Penil block group in circumcisionPudendal block group in circumcision

Eligibility Criteria

Age1 Year - 12 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • ASA I-II patients, aged 1-12 years old patient undergoing circumcision,

You may not qualify if:

  • history of local anesthetics's allergy, infection at the injection side, anatomical abnormalities, coagulopaty, bleeding disease, liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for circumcision in boys. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD003005. doi: 10.1002/14651858.CD003005.pub2.

    PMID: 18843636BACKGROUND

MeSH Terms

Interventions

Circumcision, Male

Intervention Hierarchy (Ancestors)

Body Modification, Non-TherapeuticCosmetic TechniquesTherapeuticsSurgical Procedures, OperativeUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assoc prof

Study Record Dates

First Submitted

August 20, 2017

First Posted

August 23, 2017

Study Start

November 1, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share