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NCT Number: NCT04215874

Caudal Epidural Block and DPNB in Hypospadias

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.

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Key information

Conditions

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

Age range

1 year–7 year

Sex eligibility

Male

Study type

Observational

Primary location

Okmeydani Training and Research Hospital

Istanbul, Şişli, 34384, Turkey (Türkiye)

About this study

The surgery of hypospadias is very painful in the postoperative period and requires long-term analgesia. A dorsal penile nerve block (DPNB) and caudal epidural block (CEB) are commonly used regional anesthesia techniques for postoperative pain control.

Aims: The primary aim of the current study was to use the duration until the first postoperative analgesic requirement after two different block techniques to compare the analgesic effect. The secondary aims were to compare the two methods for postoperative Children's Hospital Eastern Ontario Pain Scale (CHEOPS) scores, complications and parental satisfaction scores.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1-7 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)

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)

Treatment and study plan

Primary outcomes

  1. Time of Postoperative analgesic requirement

    Time frame: 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 outcomes

  1. Level of Postoperative pain

    Time frame: 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.

  2. Rate of Postoperative complications

    Time frame: Up to 24 hours

    Urinary retention, nausea, vomiting, lower extremity numbness, motor block were postoperative complications. They were assessed by ward nurse.

  3. Level of Parent satisfaction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study title

Caudal Epidural Block and Ultrasound-guided Dorsal Penile Nerve Block With the In-plane Technique for Pediatric Distal Hypospadias Surgery: A Prospective Observational Study

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2020
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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