Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04869046
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2020-02-03
Brief Title:
Levobupivacaine and Postoperative Pain Relief
Sponsor:
Institute for Mother and Child Health Care of Serbia Dr Vukan Cupic
Organization:
Institute for Mother and Child Health Care of Serbia Dr Vukan Cupic
Study Overview
Official Title:
Intraoperative Wound Instillation of Levobupivacaine is Effective in Postoperative Pain Management for Hernia Repair in Children a Randomized Controlled Clinical Trial
Status:
COMPLETED
Status Verified Date:
2021-05
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 study analysed direct levobupivacaine instillation in surgical wound and its effectiveness in postoperative pain control Half participants received 05 levobupivacaine and the other half received 09 saline solution
Detailed Description:
Inguinal hernia is one of the most common conditions that requires elective surgical repair in children The issue of post-operative pain in children is important particularly because the surgical intervention per se is a stressful experience after which the level of stressors in the recovery period should be minimized Stress including the pain in the postoperative period could contribute to a delayed postoperative wound healing and recovery Also untreated acute pain could interfere with cognitive function immune response as well as lead to the development of chronic postsurgical pain For this reason it is vital to reduce the painful sensations over the postoperative period as much as possible
Levobupivacaine is a long-acting local anesthetic Evidence from animal models and human volunteer participants showed that levobupivacaine has favourable effects on cardiovascular and central nervous systems Clinical studies have also showed that levobupivacaine has a very low risk of systemic toxicity A combination of levobupivacaine with non-opioid analgesics could have a beneficial role in the postoperative recovery from inguinal hernia surgery in terms of pain relief The purpose of this study was to examine the effectiveness of levobupivacaine instillation combined with the routine postoperative non-opioid analgesia in children who underwent inguinal hernia repair
It is very important for children to leave the hospital without additional support Instilled levobupivacaine applied directly to the wound currently interrupting transmission of the painful stimuli from the site of major trauma The dose of applied levobupivacaine in this study is 2 times lower than that administered for caudal block and 4 times lower than the maximum dose Analgesic effectiveness of this procedure is measured by the frequency of administration of a mixture of ibuprofen and acetaminophen over 24 hours after surgery and duration of time between the administration of two doses
Levobupivacaine is a long-acting local anesthetic Evidence from animal models and human volunteer participants showed that levobupivacaine has favourable effects on cardiovascular and central nervous systems Clinical studies have also showed that levobupivacaine has a very low risk of systemic toxicity A combination of levobupivacaine with non-opioid analgesics could have a beneficial role in the postoperative recovery from inguinal hernia surgery in terms of pain relief The purpose of this study was to examine the effectiveness of levobupivacaine instillation combined with the routine postoperative non-opioid analgesia in children who underwent inguinal hernia repair
It is very important for children to leave the hospital without additional support Instilled levobupivacaine applied directly to the wound currently interrupting transmission of the painful stimuli from the site of major trauma The dose of applied levobupivacaine in this study is 2 times lower than that administered for caudal block and 4 times lower than the maximum dose Analgesic effectiveness of this procedure is measured by the frequency of administration of a mixture of ibuprofen and acetaminophen over 24 hours after surgery and duration of time between the administration of two doses
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