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CompletedNCT03258255Updated Nov 17, 2017

Analgesic Efficiency of Pudendal Nerve Block Versus Penil Block for Circumsion in Children

An interventional study of penil or pudendal nerve block in circumcision in Postoperative Analgesia, sponsored by Istanbul University. Completed. Open to male participants aged 1 Year to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-17.

Sponsored by Istanbul University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
1 Year to 12 Years
Sex
Male
01

Study 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.

Read the detailed description

In this prospective study, patients will be randomized into 2 groups, either receiving penil Block( PNL) or nerve stimulator-guided Pudendal Nerve Block(PNB). Analgesic consumption will be assessed during the first 24 hours postoperatively. The "CHEOPS pain scale" will use to assess postoperative pain.

02

Conditions studied

  • Postoperative Analgesia
03

Who can participate

Ages eligible
1 Year to 12 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    Pudendal block group in circumcision

    Nerve stimulated pudendal nerve block performed under general anesthesia

    Procedure: penil or pudendal nerve block in circumcision

  • Active comparator
    Penil block group in circumcision

    Penil block performed by surgeon under general anesthesia

    Procedure: penil or pudendal nerve block in circumcision

Interventions

  • Procedurepenil or pudendal nerve block in circumcision

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

05

What researchers measure

Primary outcomes

  1. Postoperative pain evaluatiom

    CHEOPS pain scale

    Time frame: 24 hour

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 18843636 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03258255
Lead sponsor
Istanbul University
Responsible party
Ayse Cigdem Tutuncu (assoc prof, Istanbul University) — Principal investigator
First posted
Aug 23, 2017
Start date
Nov 2016
Primary completion
Jun 2017
Completion
Jul 2017
Last update
Nov 17, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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