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Does Neurostimulation Improve Efficacy for Ultrasound-Guided Transperineal Pudendal Nerve Block In Children

NCT03931850 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-03-11

No results posted yet for this study

Summary

This study aim to compare efficacy of transperineal pudendal nerve block between 2 techniques, by dual guidance (ultrasound and neurostimulation) vs by ultrasound-guided only, in pediatric patients who undergo circumcision.

Primary outcome : Block efficacy will be assessed from ratio of patients who receive opioids in immediate postoperative period.

Secondary outcomes :

* This study also measure other aspects of pain which can reflect the block efficacy including pain score in 24 hours, postoperative analgesic requirement in 24 hours, time to first analgesia, block success rate.
* Block performance : imaging time, needling time, total performance time,
* Block safety : collect complications from block including vascular/rectal puncture, bleeding (hematoma), local anesthetic systemic toxicity, voiding difficulty
* Parental satisfaction will be also collected which scoring use 1-5 metric.

Conditions

  • Phimosis

Interventions

PROCEDURE

Pudendal nerve block

Pudendal nerve block is the one of peripheral nerve block. Injection local anesthetic medication around this nerve can provide analgesia around perineal area.

Sponsors & Collaborators

  • Maharaj Nakorn Chiang Mai Hospital

    collaborator OTHER

  • Ramathibodi Hospital

    lead OTHER

Principal Investigators

  • Witchaya Supaopaspan, medical · Ramathibodi Hospital

  • Artid Samerchua, medical · Maharaj Nakorn Chiang Mai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Months
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2020-07-10
Completion
2020-07-10

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03931850 on ClinicalTrials.gov