Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06545058
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Safety Profile of Ropivacaine in Dorsal Penile Nerve Block for Male Circumcision a Large Cohort Study in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety Profile of Ropivacaine in Dorsal Penile Nerve Block for Male Circumcision a Large Cohort Study in Children
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dorsal penile nerve block DPNB according to Dalens technique by using local anesthetics LAs is a fundamental part of a multimodal analgesic approach following circumcision Ropivacaine has a favorable cardiovascular and neurological toxicity profile However its application in DPNB is limited because of the theoretical concerns about its vasoconstrictive properties and the potential risks of ischemia of the glans The aim is to evaluate the incidence of necrosis of the glans penis and the safety profile of ropivacaine following its use in the DPNB in a large pediatric population
Detailed Description:
Circumcision is one of the most practiced surgical procedures in childhood causing significant postoperative pain in the infant Perioperative and postoperative pain management at this age ideally should be managed by a combination of general anesthesia with regional anesthesia techniques such as caudal block dorsal penile nerve block or subcutaneous ring block of the penis
The dorsal nerves of the penis can be anesthetized at the level of the penile root through different approaches Kirya and Wertgmann described for the first time dorsal penile nerve block Since then many studies have been realized and have been showed its benefits and safety in the clinical use
Ring Blok is also known for its safety and low incidence of complications and has been used primarily for postoperative pain management in circumcision This block is easy to perform but it has been identified that it has a greater failure compared to the dorsal penile block In the study of Holder who compares dorsal penile block and ring block most of the children who has had a ring block also received opioids postoperatively
Implementation of local or regional anesthesia techniques is inevitably associated with risks and complications For DPNB this is estimated around 018 Those complications may include urethral injuries accidental injection of an incorrect drug or drug dose accidental intravascular injection of local anesthetics ischial osteomyelitis hematoma and ischemia and necrosis of the glans penis The dorsal nerves of the penis also lies close to de corpora cavernosa and the Bucks fascia Given the rich vascularized features of these structure DNPB may increase the risk of intravascular injection systemic absorption of local anesthetics or hematoma
Ischemia or even necrosis of the glans due to the placement of a penile block is a very rare complication that is not seen in the daily practice Endothelial injury and necrosis is a serious complication that can be caused due to vascular compression because of the mass effect of anesthetic solution or hematoma perforation of a vein or artery excessive cauterization a very tight suture venovasospasm at the glans secondary to surgery or the dorsal penile nerve block
Ischemia or necrosis may also be due to the vasoconstrictive effect of local anesthetics especially if they contain epinephrine
Cases of ischemia of the glans have been described after the application of the dorsal penile nerve block this was related to anesthetics that contained epinephrine or another type of vasoconstrictor agent
Ropivacaine is a local anesthetic drug with a remarkable safe cardiologic and neurologic toxicity profile specially in children Its administration for dorsal penile nerve block DPNB in male penile surgeries however has been discouraged because of the fear to cause necrosis of the glans due to its vasoconstrictor properties In Universitair Ziekenhuis Brussel we use ropivacaine for this purpose for more than 20 years now with seemingly no significant complications We want to evaluate the safety of our practice that is associated with the use of ropivacaine in DPNB in the pediatric population as well as the incidence and type of potential complications The impact may be important because there are no studies that verify the safety of this local anesthetic for those type of procedures This cohort study could eventually also serve as quality improvement
Ropivacaine is a local anesthetic amide-type that has been shown to have vascular biphasic effects with vasoconstrictive qualities These properties have been verified in Dahls study Where they identified a decrease in epidural blood flow of 37 compared to the increase in blood flow that they identified after the administration of bupivacaine
The vasoconstrictive qualities have been related with low ropivacaine concentrations like 0063 and 0125 At higher concentrations like 075 has been showed just a little decrease in blood flow comparing with saline There are currently no other studies in the literature that indicate the risk of using ropivacaine in children for Dorsal Penile Nerve Block DPNB
The dorsal nerves of the penis can be anesthetized at the level of the penile root through different approaches Kirya and Wertgmann described for the first time dorsal penile nerve block Since then many studies have been realized and have been showed its benefits and safety in the clinical use
Ring Blok is also known for its safety and low incidence of complications and has been used primarily for postoperative pain management in circumcision This block is easy to perform but it has been identified that it has a greater failure compared to the dorsal penile block In the study of Holder who compares dorsal penile block and ring block most of the children who has had a ring block also received opioids postoperatively
Implementation of local or regional anesthesia techniques is inevitably associated with risks and complications For DPNB this is estimated around 018 Those complications may include urethral injuries accidental injection of an incorrect drug or drug dose accidental intravascular injection of local anesthetics ischial osteomyelitis hematoma and ischemia and necrosis of the glans penis The dorsal nerves of the penis also lies close to de corpora cavernosa and the Bucks fascia Given the rich vascularized features of these structure DNPB may increase the risk of intravascular injection systemic absorption of local anesthetics or hematoma
Ischemia or even necrosis of the glans due to the placement of a penile block is a very rare complication that is not seen in the daily practice Endothelial injury and necrosis is a serious complication that can be caused due to vascular compression because of the mass effect of anesthetic solution or hematoma perforation of a vein or artery excessive cauterization a very tight suture venovasospasm at the glans secondary to surgery or the dorsal penile nerve block
Ischemia or necrosis may also be due to the vasoconstrictive effect of local anesthetics especially if they contain epinephrine
Cases of ischemia of the glans have been described after the application of the dorsal penile nerve block this was related to anesthetics that contained epinephrine or another type of vasoconstrictor agent
Ropivacaine is a local anesthetic drug with a remarkable safe cardiologic and neurologic toxicity profile specially in children Its administration for dorsal penile nerve block DPNB in male penile surgeries however has been discouraged because of the fear to cause necrosis of the glans due to its vasoconstrictor properties In Universitair Ziekenhuis Brussel we use ropivacaine for this purpose for more than 20 years now with seemingly no significant complications We want to evaluate the safety of our practice that is associated with the use of ropivacaine in DPNB in the pediatric population as well as the incidence and type of potential complications The impact may be important because there are no studies that verify the safety of this local anesthetic for those type of procedures This cohort study could eventually also serve as quality improvement
Ropivacaine is a local anesthetic amide-type that has been shown to have vascular biphasic effects with vasoconstrictive qualities These properties have been verified in Dahls study Where they identified a decrease in epidural blood flow of 37 compared to the increase in blood flow that they identified after the administration of bupivacaine
The vasoconstrictive qualities have been related with low ropivacaine concentrations like 0063 and 0125 At higher concentrations like 075 has been showed just a little decrease in blood flow comparing with saline There are currently no other studies in the literature that indicate the risk of using ropivacaine in children for Dorsal Penile Nerve Block DPNB
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None