Dorsal Nerve Block and Caudal Block in Hypospedius Repair in Children

NCT06500286 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: Dorsal block in hypospedius
• Study Type: interventional
• Target: 103
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparison between Dorsal nerve block and caudal block effect in post operative pain in hypospedius repair in children Randomoized clinical trial

Conditions

Dorsal Nerve Block in Hypospiudus

Outcome Measures

Primary Outcomes (1)

• Efficacy of dorsal penile block

  Score of pain visual Analougue Score

  1year

Secondary Outcomes (1)

• Comparison between post operative analegesia effect and side effect of dorsal penileblock and caudal block

  1year

Study Arms (2)

Group A

EXPERIMENTAL

• Group A receive caudal block placing the patient into the left lateral decubitus position. . The sacral hiatus was found by palpating the sacral cornu and a 22-G needle was placed through it. After passing through the sacrococcygeal 0.25% bupivacaine was administered at a dose of 0.2 ml/kg.the procedure was completed, the patient was placed into the supine Position.

Drug: Marciane

Group B

EXPERIMENTAL

Group B US guided Dorsal penil block. The 5-10 MHz linear probe was placed at the penis root, making it possible to observe the corpus cavernosum, corpus spongiosum, dorsal artery and vein, and the deep penile fascia (Buck's fascia) on the transverse plane with gentle penile traction. The in-plane technique was then used to insert a 50-mm block needle toward the dorsal penile section from the lateral part of the penis root. The needle was then advanced from the hyperechoic superficial penis fascia (Dartos fascia) and the superficial sheath was passed. After advancing the needle into Buck's fascia, the needle was placed lateral to the dorsal artery, at a position between Buck's fascia and tunica albuginea. Negative aspiration was performed. US was then used to observe the distribution of the anesthetic while half of the total 0.25% bupivacaine dose (0.2 mL/kg) was administered (Fig. 1). Afterward, the same procedure was also performed on the other side of the penis.

Drug: Marcaine

Interventions

Marciane DRUG

Group A caudal block 0.25% bupivacaine was administered at a dose of 0.2 ml/k

Also known as: bupivacaine

Group A

Marcaine DRUG

Dorsal penil block 0.25% bupivacaine was administered at a dose of 0.2 ml/k

Also known as: bupivacaine

Group B

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• aged 2-12 years
• ASA physical status I or II

You may not qualify if:

• asthmatic patients
• emergency surgery
• intellectual disability
• neurological diseases with agitation-like symptoms
• renal or hepatic disease,
• cardiac or respiratory disease
• allergy to the study drugs
• parent refusal
• psychiatric diseases

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Baskin LS, Lee YT, Cunha GR. Neuroanatomical ontogeny of the human fetal penis. Br J Urol. 1997 Apr;79(4):628-40. doi: 10.1046/j.1464-410x.1997.00119.x.

  PMID: 9126098 RESULT

• Ngoo A, Borzi P, McBride CA, Patel B. Penile nerve block predicts higher revision surgery rate following distal hypospadias repair when compared with caudal epidural block: A consecutive cohort study. J Pediatr Urol. 2020 Aug;16(4):439.e1-439.e6. doi: 10.1016/j.jpurol.2020.05.150. Epub 2020 Jun 6.

  PMID: 32636118 RESULT

• Hueber PA, Salgado Diaz M, Chaussy Y, Franc-Guimond J, Barrieras D, Houle AM. Long-term functional outcomes after penoscrotal hypospadias repair: A retrospective comparative study of proximal TIP, Onlay, and Duckett. J Pediatr Urol. 2016 Aug;12(4):198.e1-6. doi: 10.1016/j.jpurol.2016.04.034. Epub 2016 Jun 2.

  PMID: 27318548 RESULT

• Spinoit AF, Poelaert F, Van Praet C, Groen LA, Van Laecke E, Hoebeke P. Grade of hypospadias is the only factor predicting for re-intervention after primary hypospadias repair: a multivariate analysis from a cohort of 474 patients. J Pediatr Urol. 2015 Apr;11(2):70.e1-6. doi: 10.1016/j.jpurol.2014.11.014. Epub 2015 Feb 26.

  PMID: 25797860 RESULT

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Soha Abdelhamid Fawzy, Resident

  Resident

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soha Abdelhamid Fawzy, Resident

CONTACT

01061424208; sohaSoha.abd.elhamid.3@gmail.com

Mohammed Sayed abdelal, Assistant

CONTACT

01001204222; Saikl_2015@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor in assiut university hospitals

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: July 15, 2024
• Study Start: August 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 15, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share