Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410482
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2023-11-14
Brief Title:
Analgesia in Pediatric Hypospadias Surgeries
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Comparison Between the Analgesic Efficacy of the Ultrasound Penile Block Versus Ultrasound Caudal Epidural for Pediatric Hypospadias Surgeries A Prospective Randomized Double Blinded Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary aim of the current study will be to use the duration until the first postoperative analgesic requirement after two different block techniques to compare the analgesic effect
The secondary aims will be to compare the two methods for postoperative Childrens Hospital Eastern Ontario Pain Scale CHEOPS scores complications and parental satisfaction scores
The secondary aims will be to compare the two methods for postoperative Childrens Hospital Eastern Ontario Pain Scale CHEOPS scores complications and parental satisfaction scores
Detailed Description:
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
Although current guidelines propose an optimal age for hypospadias repair of 6-18 months patient ages vary widely from infants to adults in daily practice According to the literature hypospadias surgery can be performed in a wide age range of 6 months-12 years The age of the patients undergoing hypospadias surgery in our country can vary between 1 and 10 years 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
A dorsal penile nerve block DPNB and caudal epidural block CEB are commonly used regional anesthesia techniques for postoperative pain control in hypospadias repair CEB is the more commonly used neuraxial block method for providing effective postoperative analgesia in lower abdominal urogenital and lower extremity surgical operations in pediatric patients However it has recently been suggested in the literature that peripheral nerve blocks should be preferred to neuraxial blocks as they provide longer-term analgesia and have fewer side effects DPNB is a peripheral nerve block method that has been widely used for various penile operations since it will be first defined in the mid-1970s This method is mostly used with the landmark technique It will be first used by Sandeman et al via the out-of-plane technique with ultrasound US and will be reported to provide effective analgesia in the postoperative period Suleman et al described DPNB for the first time with the in-plane technique indicating that the tissue and neurovascular structures of the penis could be better distinguished in the transverse plane in ultrasound US A limited number of studies have shown the technique to provide more effective and longer term postoperative analgesia compared to the landmark technique and CEB
Although current guidelines propose an optimal age for hypospadias repair of 6-18 months patient ages vary widely from infants to adults in daily practice According to the literature hypospadias surgery can be performed in a wide age range of 6 months-12 years The age of the patients undergoing hypospadias surgery in our country can vary between 1 and 10 years 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
A dorsal penile nerve block DPNB and caudal epidural block CEB are commonly used regional anesthesia techniques for postoperative pain control in hypospadias repair CEB is the more commonly used neuraxial block method for providing effective postoperative analgesia in lower abdominal urogenital and lower extremity surgical operations in pediatric patients However it has recently been suggested in the literature that peripheral nerve blocks should be preferred to neuraxial blocks as they provide longer-term analgesia and have fewer side effects DPNB is a peripheral nerve block method that has been widely used for various penile operations since it will be first defined in the mid-1970s This method is mostly used with the landmark technique It will be first used by Sandeman et al via the out-of-plane technique with ultrasound US and will be reported to provide effective analgesia in the postoperative period Suleman et al described DPNB for the first time with the in-plane technique indicating that the tissue and neurovascular structures of the penis could be better distinguished in the transverse plane in ultrasound US A limited number of studies have shown the technique to provide more effective and longer term postoperative analgesia compared to the landmark technique and CEB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None