Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558149
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
The Effect of Nociception Level NOL Monitoring on Intraoperative Opioid Consumption in Hip Surgeries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Nociception Level NOL Monitoring on Intraoperative Opioid Consumption in Hip Surgeries
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
Hip surgeries are one of the most painful surgical operations and inadequate pain management increases postoperative morbidity and mortalityThe incidence of chronic pain after hip surgery is quite high at 11-40For this reason hip surgeries are complex and specialized surgeries in terms of pain managementAccording to the surgical procedures pioneered by the European Society of Regional Anesthesia Pericapsular nerve block PENG block is among the recommendations with a high level of evidence for hip surgery in the multimodal analgesia steps guideIn the literature there are studies comparing the postoperative analgesic effectiveness of PENG block in hip surgeries but the results are contradictoryIn addition intraoperative pain monitoring was not used in these studies instead intraoperative analgesia management was provided according to hemodynamic parameters which may not be objectiveOpioid infusion is used in analgesia management during the intraoperative periodWhile not providing effective analgesia due to insufficient opioid use will have effects excessive opioid use also has many side effectsTherefore it would not be correct to administer the same dose of opioid infusion to every patient As seen in the data in the literature and in daily practice hemodynamic parameters such as heart rate blood pressure are used for pain monitoring of the patient under general anesthesia and these parameters may change depending on many other factorsAlthough some devices that aim to provide pain monitoring by evaluating the effects of pain on the sympathetic system are available on the market their usage areas have remained limited since their reliability has not been fully demonstrated Nociception level index NoL monitoring provides effective monitoring as it evaluates each patient separately using different parameters heart rate heart rate variability photo-plethysmographic waveform amplitude skin conductance level number of skin conductance fluctuations and their time derivativesWhile planning this study İnvestigators aimed to use NoL monitoring in hip surgery where postoperative pain management is quite challenging and important as it provides objective and personalized pain management in patients under general anesthesiaWhen other studies in the literature are examined the effects of regional techniques have been compared only in the postoperative periodIts effects in the intraoperative period have not been evaluated on a patient basis and the opioid infusion rate has been adjusted with hemodynamic findings which are affected by many parameters such as bleeding and drug useIn this study İnvestigators aim to compare the effects of intraoperative pain monitoring and personalized analgesia treatment and the regional technique both in the intraoperative period and in the postoperative period
Detailed Description:
None
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