Caudal Epidural Block and DPNB in Hypospadias

August 10, 2020 updated by: Volkan Ozen, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Şişli
      • Istanbul, Şişli, Turkey, 34384
        • Okmeydani Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 7 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 24 hours
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.
Up to 24 hours
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.
Up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Investigators

  • Study Director: Volkan Ozen, MD, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 14, 2019

Primary Completion (ACTUAL)

December 15, 2019

Study Completion (ACTUAL)

December 15, 2019

Study Registration Dates

First Submitted

December 28, 2019

First Submitted That Met QC Criteria

December 31, 2019

First Posted (ACTUAL)

January 2, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2020

Last Update Submitted That Met QC Criteria

August 10, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/1219

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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