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

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ClinicalTrials.gov Identifier: NCT03258255
Recruitment Status : Completed
First Posted : August 23, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Ayse Cigdem Tutuncu, Istanbul University

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.

Condition or disease Intervention/treatment Phase
Postoperative Analgesia Procedure: penil or pudendal nerve block in circumcision Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Analgesic Efficiency of Pudendal Nerve Block and Penil Block for Circumsion in Children
Actual Study Start Date : November 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : July 2017

Arm Intervention/treatment
Active Comparator: Pudendal block group in circumcision
Nerve stimulated pudendal nerve block performed under general anesthesia
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

Active Comparator: Penil block group in circumcision
Penil block performed by surgeon under general anesthesia
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




Primary Outcome Measures :
  1. Postoperative pain evaluatiom [ Time Frame: 24 hour ]
    CHEOPS pain scale



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Ages Eligible for Study:   1 Year to 12 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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


Publications:
Responsible Party: Ayse Cigdem Tutuncu, assoc prof, Istanbul University
ClinicalTrials.gov Identifier: NCT03258255     History of Changes
Other Study ID Numbers: 242893
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs