Caudal Epidural Block and DPNB in Hypospadias

NCT04215874 | Completed

• 1 other identifier: 2019/1219
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Hypospadias, seen in every 200-300 births, is one of the most common congenital anomalies of the penis and is defined as the urethral meatus being located in the ventral part of the penis instead of its normal place. The surgery of this anomaly is very painful in the postoperative period and requires long-term analgesia. Regional anesthesia methods combined with general anesthesia play an important role in providing effective and long-term postoperative pain control in pediatric penile surgery. These methods also reduce postoperative morbidity, enable early mobilization and significantly decrease the need for narcotic analgesics. The investigator's hypothesis is peripheral nerve blocks are superior to neuraxial blocks as the blocks provide longer-term analgesia and have fewer side effects.

Conditions

Hypospadias; Postoperative Pain

Keywords

dorsal penile nerve block; caudal epidural block; postoperative pain; analgesia; hypospadias; ultrasound

Outcome Measures

Primary Outcomes (1)

• Time of Postoperative analgesic requirement

  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.

  Up to 24 hours

Secondary Outcomes (3)

• Level of Postoperative pain

  Up to 24 hours

• Rate of Postoperative complications

  Up to 24 hours

• Level of Parent satisfaction

  Up to 24 hours

Study Arms (2)

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.

Caudal epidural block group

A 22 G needle was inserted through the sacral hiatus. The loss of resistance method was used to pass through the sacrococcygeal membrane and enter the caudal epidural space. Negative aspiration was then performed 0.25% bupivacaine at a dose of 0.2 ml/kg was administered.

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study was conducted with children who underwent hypospadias surgery at a training and research hospital in Istanbul, Turkey.

You may qualify if:

• years of age
• ASA (American Society of Anesthesiologists) I-II group
• Scheduled for distal hypospadias surgery
• Able to communicate in Turkish
• Willing to participate to the study (parents and children)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Study Sites (1)

Okmeydani Training and Research Hospital

Istanbul, Şişli, 34384, Turkey (Türkiye)

Location

Related Publications (4)

• Alizadeh F, Heydari SM, Nejadgashti R. Effectiveness of caudal epidural block on interaoperative blood loss during hypospadias repair: A randomized clinical trial. J Pediatr Urol. 2018 Oct;14(5):420.e1-420.e5. doi: 10.1016/j.jpurol.2018.03.025. Epub 2018 May 21.

  PMID: 29858133 BACKGROUND

• Kundra P, Yuvaraj K, Agrawal K, Krishnappa S, Kumar LT. Surgical outcome in children undergoing hypospadias repair under caudal epidural vs penile block. Paediatr Anaesth. 2012 Jul;22(7):707-12. doi: 10.1111/j.1460-9592.2011.03702.x. Epub 2011 Sep 29.

  PMID: 21957982 BACKGROUND

• Suleman MI, Akbar Ali AN, Kanarek V, Li M, Patel A. Ultrasound Guided In-Plane Penile Nerve Block for Circumcision: A New, Modified Technique Suggests Lower Anesthetic Volume and Narcotic Use. Middle East J Anaesthesiol. 2016 Oct;23(6):647-53.

  PMID: 29939703 BACKGROUND

• Ozen V, Yigit D. Caudal epidural block versus ultrasound-guided dorsal penile nerve block for pediatric distal hypospadias surgery: A prospective, observational study. J Pediatr Urol. 2020 Aug;16(4):438.e1-438.e8. doi: 10.1016/j.jpurol.2020.05.009. Epub 2020 May 20.

  PMID: 32507565 DERIVED

MeSH Terms

Conditions

Hypospadias; Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Volkan Ozen, MD

  Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 28, 2019
• First Posted: January 2, 2020
• Study Start: April 14, 2019
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)