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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03258255
Other study ID # 242893
Secondary ID
Status Completed
Phase N/A
First received August 20, 2017
Last updated November 15, 2017
Start date November 2016
Est. completion date July 2017

Study information

Verified date November 2017
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date July 2017
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 1 Year to 12 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
penil 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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University

References & 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;(4):CD003005. doi: 10.1002/14651858.CD003005.pub2. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain evaluatiom CHEOPS pain scale 24 hour
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