Ultrasound-guided PNB and DPNB for Pediatric Distal Hypospadias Surgery

Completed

• Conditions: Hypospadias; Regional Anesthesia
• Interventions: Procedure: Dorsal penile nerve block group; Procedure: Pudendal nerve block group

• Registration Number: NCT04668183
• Lead Sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Brief Summary

Hypospadias repair is a urological surgical operation that is very painful in the postoperative period and requires long-term analgesia. A dorsal penial nerve block (DPNB) and pudendal nerve block (PNB), which are regional anesthesia techniques for this operation, are used to provide postoperative analgesia.

Detailed Description

The regional anesthesia techniques used for postoperative analgesia in hypospadias repair include the peripheral nerve blocks of pudendal nerve block (PNB) and dorsal penile nerve block (DPNB). Ultrasound (US) has recently become increasingly popular in regional anesthesia practice and is used to aid these two peripheral nerve block applications in various pediatric urological procedures. US-guided DPNB has been shown to provide effective and long-term analgesia when compared to caudal epidural block in a recent study on hypospadias surgery in the pediatric population.

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2020-04-01
• Study Completion: 2020-08-01
• Status Verified: 2020-12
• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-14
• Last Update Submitted: 2020-12-14
• Study First Posted: 2020-12-16
• Last Update Posted: 2020-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Male patients aged between 1-7 years
• American Society of Anesthesiologists (ASA) I-II group
• Distal hypospadias surgery
• Able to communicate in Turkish
• Willing to participate to the study (parents and children)

Exclusion Criteria

• Less than 1 or more than 7 years of age
• A neurological deficit, bleeding diathesis, or a history of local anesthetic allergy; an infection or redness in the injection area, congenital low back anomaly, liver disorder, a psychiatric disorder, mental retardation, or communication problems detected during examination
• Unwilling to to participate to the study ((parents or children)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dorsal Penile Nerve Block	Dorsal penile nerve block group	Ultrasound (US) guided dorsal penile nerve block with in plane technique was done. Half of the total 0.2 ml/kg dose of 0.25% bupivacaine was administered while observing its distribution with US. The same procedure was then repeated on the other side of the penis.
Pudendal Nerve Block	Pudendal nerve block group	Linear ultrasound probe and the sacral hiatus at the sacral cornu level was visualized using an out-of-plane transverse view at 5-10 megahertz . The linear probe was then rotated 90 degrees and placed longitudinally in the midline to evaluate the sacral cornus, sacrococcygeal ligament and sacral bone.

Primary Outcome Measures

Name	Time	Method
Time of Postoperative analgesic requirement	Up to 24 hours	It was assessed six times after the operation with Children's Hospital Eastern Ontario Pain Scale. The lowest scale score is 4 points and the highest 13 points. Significant pain behavior for Children's Hospital Eastern Ontario Pain Scale has been identified as 7 points or more. Following transfer from the recovery unit to the ward, the 1st, 2nd, 6th, 12th and 24th hour pain levels were evaluated by the ward nurse. Paracetamol was administered IV at a dose of 10 mg/kg if the scale score was 7 or higher.

Secondary Outcome Measures

Name	Time	Method
Rate of Postoperative complications	Up to 24 hours	The presence of penile edema or an injection site ecchymosis or hematoma was evaluated by an anesthesiologist blinded to the study groups postoperatively (at 30 minutes and 1, 2, 6, 12, 18 and 24 hours).
Level of Postoperative pain	Up to 24 hours]	It was assessed six times after the operation with Children's Hospital Eastern Ontario Pain Scale. The lowest scale score is 4 points and the highest 13 points. Significant pain behavior for Children's Hospital Eastern Ontario Pain Scale has been identified as 7 points or more. Following transfer from the recovery unit to the ward, the 1st, 2nd, 6th, 12th and 24th hour pain levels were evaluated by the ward nurse
Level of Parent satisfaction	Up to 24 hours	The parents were asked about their satisfaction with the child's comfort and activity level \[1, unsatisfied; 2, satisfied (good); 3, absolutely satisfied (excellent)\] at the 24-hour follow-up

Trial Locations

Locations (1)

Prof. Dr. Cemil Tascioglu City Hospital; 🇹🇷 Istanbul, Turkey