Caudal Epidural Block and DPNB in Hypospadias

Study Overview
=================
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.

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.

Official 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

Conditions
-----------------
Hypospadias, Postoperative Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 7 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dorsal penile nerve block group<br>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<br>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 | 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 Postoperative pain | 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 | Urinary retention, nausea, vomiting, lower extremity numbness, motor block were postoperative complications. They were assessed by ward nurse. | Up to 24 hours | 
| Level of Parent satisfaction | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dorsal penile nerve block, caudal epidural block, postoperative pain, analgesia, hypospadias, ultrasound