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Ultrasound-guided pudendal nerve block (PNB) for Regional Anesthesia

N/A

Waitlist Available

Research Sponsored by CHU de Quebec-Universite Laval

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

Study Summary

This trial is studying whether ultrasound-guided pudendal nerve block is better than ultrasound-guided dorsal penile nerve block for pain relief during and after circumcision surgery in children.

Eligible Conditions

Regional Anesthesia
Circumcision

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Impact of regional block on FLACC pain scores after circumcision

Epidural Anesthesia

Secondary outcome measures

Impact of regional block on analgesic consumption after circumcision

Trial Design

2Treatment groups

Active Control

Group I: Ultrasound-guided pudendal nerve block (PNB)Active Control1 Intervention

Standard circumcision under general anaesthesia with ultrasound-guided pudendal nerve block.Pudendal nerve block patients will be positioned dorsally with the legs in the " frog " position (hips in abduction, knees flexed, sole of the feet together). An ultrasound-guided technique will be used as described previously. A linear probe will be positioned horizontally between the ischiatic tuberosity and the rectum. The ischiorectal fossa is then located between these two landmarks. Using a sterile tech-nique, an echogenic 22 gauge, 50 mm block needle will be inserted out of plane on the superior edge of the probe, midline between the ischiatic tuberosity and the rectum. After feeling two distinct fascial " clics " and confirmation of correct needle posi-tioning in the ischiorectal fossa under ultrasound, 0,2 mL/kg (max 10mL) of ropiva-caine 0,25% will be injected under real-time ultrasound-guidance after negative aspiration. The same technique will be repeated on the contralateral side.

Group II: Ultrasound-guided penile nerve block (DPNB)Active Control1 Intervention

Standard circumcision under general anaes-thesia with ultrasound-guided penile nerve block.Penile nerve block patients will be positioned in the supine position. An ultrasound-guided technique will be used as described previously. A linear probe will be placed transversely at the base of the penis while an assistant applies caudal traction to the penis. The penile neurovascular sheath is then located just above the corpus cavernosum. The dorsal penile nerve, dorsal penile artery and penile deep dorsal vein are visualized deep to Buck's fascia. Using a sterile technique, a 25 gauge, 1,5 inch needle will be inserted in-plane from lateral to medial so that the needle tip is placed into the penile neurovascular sheath, 0,1 mL/kg (max 4 mL) of ropivacaine 0,25% will be injected under real-time ultrasound guidance while retracting the needle so that the local anaesthetic solution spreads bilaterally filling the neurovascular space.

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Who is running the clinical trial?

CHU de Quebec-Universite LavalLead Sponsor

167 Previous Clinical Trials

106,857 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the participant pool of this investigation restricted to individuals aged 45 or younger?

"This medical research is open to patients between 1 and 12 years old. To provide an equitable experience, there are three studies targeting minors and seven specifically for seniors over 65."

Answered by AI

Am I eligible to enroll in this experimentation?

"This clinical trial requires 300 male participants from 1 to 12 years of age who are undergoing elective circumcision for medical reasons."

Answered by AI

Is this experiment open to new participants?

"According to the information found on clinicaltrials.gov, this trail is no longer accepting patients as recruiting ended after its last update on August 4th 2021. However, 12 other studies are presently taking partcipants at this time."

Answered by AI

Recent research and studies

American Journal of Obstetrics and GynecologyJournal

A Randomized, Controlled Trial of a Eutectic Mixture of Local Anesthetic Cream (lidocaine and Prilocaine) Versus Penile Nerve Block for Pain Relief During Circumcision

Howard, Cynthia R., Fred M. Howard, Karen Fortune, Patricia Generelli, Denniz Zolnoun, Cynthia tenHoopen, and Elisabeth deBlieck. 1999. “A Randomized, Controlled Trial of a Eutectic Mixture of Local Anesthetic Cream (lidocaine and Prilocaine) Versus Penile Nerve Block for Pain Relief During Circumcision”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/s0002-9378(99)70397-2.

Journal of Pediatric UrologyJournal

A Comparison of the Postoperative Analgesic Effectiveness of Low Dose Caudal Epidural Block and Us-guided Dorsal Penile Nerve Block with In-plane Technique in Circumcision

Ozen, Volkan, and Dogakan Yigit. 2020. “A Comparison of the Postoperative Analgesic Effectiveness of Low Dose Caudal Epidural Block and Us-guided Dorsal Penile Nerve Block with In-plane Technique in Circumcision”. Journal of Pediatric Urology. Elsevier BV. doi:10.1016/j.jpurol.2019.10.020.

Canadian Urological Association JournalJournal

CUA Guideline on the Care of the Normal Foreskin and Neonatal Circumcision in Canadian Infants

Dave, Sumit, Kourosh Afshar, Luis H. Braga, and Peter Anderson. 2017. “CUA Guideline on the Care of the Normal Foreskin and Neonatal Circumcision in Canadian Infants”. Canadian Urological Association Journal. Canadian Urological Association Journal. doi:10.5489/cuaj.5033.

PediatricsJournal