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

NCT ID: NCT03258255

Last Updated: 2017-11-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-07-31

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.

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.

Conditions

Postoperative Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pudendal block group in circumcision

Nerve stimulated pudendal nerve block performed under general anesthesia

Group Type: ACTIVE_COMPARATOR

penil or pudendal nerve block in circumcision

Intervention Type: PROCEDURE

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 circumcision

Penil block performed by surgeon under general anesthesia

Group Type: ACTIVE_COMPARATOR

penil or pudendal nerve block in circumcision

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Ayse Cigdem Tutuncu

assoc prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 18843636 (View on PubMed)

Other Identifiers

242893

Identifier Type: -

Identifier Source: org_study_id