Ignite Creation Date:
2024-05-06 @ 1:26 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04024319
Status:
COMPLETED
Last Update Posted:
2019-07-18
First Post:
2019-07-15
Brief Title:
Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty GenTKR
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Ultrasound-guided Genicular Nerve Block an Analgesic Alternative to LIA for Total Knee Arthroplasty Case-control Series
Status:
COMPLETED
Status Verified Date:
2019-07
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:
GenTKR
Brief Summary:
Knee Osteoarthritis affects one third of the population over 65 years old Total knee arthroplasty TKA has become one of the most frequent surgical procedures in the world During the last years it went from being a long hospital stay surgery to a fast track procedure Currently models employ high volume local infiltration techniques LIA The genicular nerve block GNB appears as alternative in this patients
The objective of this study is to evaluate the analgesic results of genicular nerve block after TKA in a small cohort of patients
35 patients scheduled for TKA underwent to GNB were included Pain measurement
The objective of this study is to evaluate the analgesic results of genicular nerve block after TKA in a small cohort of patients
35 patients scheduled for TKA underwent to GNB were included Pain measurement
Detailed Description:
An observational study of a series of 35 cases will be carried out based on the casuistry of TKR surgery of the investigators center The performance of analgesic blockade called GNB in adult patients ASA physical status I-III which will undergo TKR will be part of the multimodal analgesia strategy
After compliance with the inclusion criteria with the acceptance and signature of the informed consent by the participating patients the following procedure will be followed
1 Patients will be routinely assessed by an anesthesiologist of the service later they will enter the operating room where the vital signs will be monitored and the usual anesthetic technique will be used for TKR that is spinal anesthesia
2 To perform the blocks a 90 mm needle was used with a 30mm extension connected to a 20ml syringe with a mixture of 20ml of 02 ropivacaine 200 micrograms of adrenaline The needle will be advanced with an out-of-plane technique and 4 ml of the described solution will be placed in each of the 5 nerves to be blocked Superomedial genicular nerve SMGN Superolateral genicular nerve SLGN Inferomedial genicular nerve IMGN Inferolateral genicular nerve ILGN and Recurrent tibial genicular nerve RTGN
3 The pain assessment will be carried out during the night after the intervention approximately 12 hours and the next morning approximately 24 hours The pain will be objectified by VAS 0-10 by a nurse blind to the analgesic treatment The use of rescue opioids will be indicated in case of VAS 3 data that will also be analyzed In the room the pharmacological treatment established as an institutional protocol will continue It should be noted that these data as well as demographic data intraoperative times and relevant post-operative data hematocrit complication were obtained from the clinical records of the electronic file of the program used in the internal network of the Barcelona Clinic Hospital
4 Researchers will record those variables aimed at evaluating the intensity of acute postoperative pain 24 hours after TKR Pain score 4 in any time
These results will be included anonymously in an Excel database made for this purpose for further analysis The variables will be recorded in a single intervention
After compliance with the inclusion criteria with the acceptance and signature of the informed consent by the participating patients the following procedure will be followed
1 Patients will be routinely assessed by an anesthesiologist of the service later they will enter the operating room where the vital signs will be monitored and the usual anesthetic technique will be used for TKR that is spinal anesthesia
2 To perform the blocks a 90 mm needle was used with a 30mm extension connected to a 20ml syringe with a mixture of 20ml of 02 ropivacaine 200 micrograms of adrenaline The needle will be advanced with an out-of-plane technique and 4 ml of the described solution will be placed in each of the 5 nerves to be blocked Superomedial genicular nerve SMGN Superolateral genicular nerve SLGN Inferomedial genicular nerve IMGN Inferolateral genicular nerve ILGN and Recurrent tibial genicular nerve RTGN
3 The pain assessment will be carried out during the night after the intervention approximately 12 hours and the next morning approximately 24 hours The pain will be objectified by VAS 0-10 by a nurse blind to the analgesic treatment The use of rescue opioids will be indicated in case of VAS 3 data that will also be analyzed In the room the pharmacological treatment established as an institutional protocol will continue It should be noted that these data as well as demographic data intraoperative times and relevant post-operative data hematocrit complication were obtained from the clinical records of the electronic file of the program used in the internal network of the Barcelona Clinic Hospital
4 Researchers will record those variables aimed at evaluating the intensity of acute postoperative pain 24 hours after TKR Pain score 4 in any time
These results will be included anonymously in an Excel database made for this purpose for further analysis The variables will be recorded in a single intervention
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