Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06019039
Status:
RECRUITING
Last Update Posted:
2023-08-31
First Post:
2023-08-15
Brief Title:
Power Doppler Ultrasonography in Localization of Epidural Catheter
Sponsor:
Yasser S Mostafa MD
Organization:
Fayoum University Hospital
Study Overview
Official Title:
The Role of Power Doppler Ultrasonography in Localization of Epidural Catheter an Observational Prospective Study
Status:
RECRUITING
Status Verified Date:
2023-08
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:
Epidural anesthesia is a widely used method for pain relief which is useful in various settings Identification of needle entry into the epidural space EDS is performed most using a loss of resistance LOR technique which was described in 1921 by Sicard and Forestier and has remained largely unchanged since Hysterectomy operations anesthesia and analgesia rely heavily on proper needle placement technique A noninvasive approach to confirm the correct position of the epidural needle prior to injection of local anesthetics into the epidural space would thus be beneficial Ultrasound US is a noninvasive approach increasingly used in anesthesia practice The use of color flow Doppler CFD may further aid in defining the epidural space The aim of current study is to detect and confirm site of epidural catheter in hysterectomy by using color flow doppler ultrasonography
Detailed Description:
This study will be performed in the Fayoum University hospital The study design will be prospective study A detailed informed consent will be signed by the eligible patients
female patients who undergoing an ultrasound guided for hysterectomy will be included in this review The ultrasound guided epidural will be used in those in which an anticipated technical difficult landmark epidural space localization will be expected These included those patients with diagnosis of obesity defined as Body Mass Index BMI 35 kgm2 and lumbar scoliosis as well as those with poorly defined surface lumbar bone anatomy
Demographic data intervertebral level of insertion dermatome level and failure rate of epidural needle placement using CFD will be noted for each patient Operation will be obtained via spinal epidural technique
Sterile preparation and dropping of the area will be followed by placement of a curvilinear ultrasound transducer in a sterile sheath The ultrasound will be used to identify the interspinous space The epidural needle will be guided with the use of ultrasound direction by the use of an out of plane technique
A two-hand technique will be used to manipulate the needle and ultrasound probe
A 17-G Tuohy needle Braun Medical Inc MelsungenAG Germany will be advanced until loss of resistance to normal saline will be attained
Confirmation of the epidural space with the use of CFD will be then obtained after injection of up to 10 mL of normal saline through the epidural needle
A 21-G epidural catheter B Braun Medical Inc will be then threaded into the epidural space
A 22G 50mm needle SONOTAPPajunkGeisingenGermany will be then advanced until CSF is obtained
Use of intrathecal local anesthetic will be then used as a bolus in the spinal space
After loss of resistance to normal saline the CFD function will be turned on to examine flow through the epidural needle tip
The ultrasound probe was positioned in the transverse axis slightly below the epidural needle but still in the interspinous space
Two-dimensional 2D ultrasound images will be initially obtained after making adjustments on the ultrasound system
These include an appropriate scanning depth 6-12 cm using the penetration or general frequency range and adjusting the gain or the time gate compensation to improve image resolution
The CFD function will be then turned on and then the window will be adjusted to be centered over the area of interest The authors will adjust color baseline to enhance the qualitative depiction of flow The authors also increased color gain to amplify the appearance of flow changes The color gain was adjusted to a level that provided the best image while avoiding the display of random color speckles The orientation and tilt of the ultrasound probe will be essential for optimal visualization of the CFD pattern
The best views were obtained while the probe was tilted upwards parallel to the lumbar spinous process orientation in order to avoid shadow interference cast by the spinous process bony structure This maneuver will optimize the 2D view by minimizing the shadowing caused by bony structures
The color scale will be adjusted to maximize color flow while avoiding excessive aliasing
The best images will be best seen with a color scale on the range of 12-20 without needing to adjust the baseline
Sample size was calculated using G-Power software version 317 Institute of experimental psychology Heinrich Heine University Dusseldorf GermanyMinimal sample size of patients was 60 patients Effect size 047 Depending on previous research results Two tailed type I error 005 and power of 80
Statistical analysis will be performed using SPSS version 240 IBM Armonk NY USA Data will be tested for normality using the Kolmogorov-Smirnov test Continuous variables are presented as mean standard deviation SD or median interquartile range as appropriate and categorical variables are presented as number of patients Parametric continuous variables will be analyzed by unpaired t-test and non-parametric continuous variables will be analyzed by Mann-Whitney U test For categorical variables the Chi-square X2 test or Fishers exact test will be used as appropriate Two-tailed p values of 005 will be considered statistically significant
female patients who undergoing an ultrasound guided for hysterectomy will be included in this review The ultrasound guided epidural will be used in those in which an anticipated technical difficult landmark epidural space localization will be expected These included those patients with diagnosis of obesity defined as Body Mass Index BMI 35 kgm2 and lumbar scoliosis as well as those with poorly defined surface lumbar bone anatomy
Demographic data intervertebral level of insertion dermatome level and failure rate of epidural needle placement using CFD will be noted for each patient Operation will be obtained via spinal epidural technique
Sterile preparation and dropping of the area will be followed by placement of a curvilinear ultrasound transducer in a sterile sheath The ultrasound will be used to identify the interspinous space The epidural needle will be guided with the use of ultrasound direction by the use of an out of plane technique
A two-hand technique will be used to manipulate the needle and ultrasound probe
A 17-G Tuohy needle Braun Medical Inc MelsungenAG Germany will be advanced until loss of resistance to normal saline will be attained
Confirmation of the epidural space with the use of CFD will be then obtained after injection of up to 10 mL of normal saline through the epidural needle
A 21-G epidural catheter B Braun Medical Inc will be then threaded into the epidural space
A 22G 50mm needle SONOTAPPajunkGeisingenGermany will be then advanced until CSF is obtained
Use of intrathecal local anesthetic will be then used as a bolus in the spinal space
After loss of resistance to normal saline the CFD function will be turned on to examine flow through the epidural needle tip
The ultrasound probe was positioned in the transverse axis slightly below the epidural needle but still in the interspinous space
Two-dimensional 2D ultrasound images will be initially obtained after making adjustments on the ultrasound system
These include an appropriate scanning depth 6-12 cm using the penetration or general frequency range and adjusting the gain or the time gate compensation to improve image resolution
The CFD function will be then turned on and then the window will be adjusted to be centered over the area of interest The authors will adjust color baseline to enhance the qualitative depiction of flow The authors also increased color gain to amplify the appearance of flow changes The color gain was adjusted to a level that provided the best image while avoiding the display of random color speckles The orientation and tilt of the ultrasound probe will be essential for optimal visualization of the CFD pattern
The best views were obtained while the probe was tilted upwards parallel to the lumbar spinous process orientation in order to avoid shadow interference cast by the spinous process bony structure This maneuver will optimize the 2D view by minimizing the shadowing caused by bony structures
The color scale will be adjusted to maximize color flow while avoiding excessive aliasing
The best images will be best seen with a color scale on the range of 12-20 without needing to adjust the baseline
Sample size was calculated using G-Power software version 317 Institute of experimental psychology Heinrich Heine University Dusseldorf GermanyMinimal sample size of patients was 60 patients Effect size 047 Depending on previous research results Two tailed type I error 005 and power of 80
Statistical analysis will be performed using SPSS version 240 IBM Armonk NY USA Data will be tested for normality using the Kolmogorov-Smirnov test Continuous variables are presented as mean standard deviation SD or median interquartile range as appropriate and categorical variables are presented as number of patients Parametric continuous variables will be analyzed by unpaired t-test and non-parametric continuous variables will be analyzed by Mann-Whitney U test For categorical variables the Chi-square X2 test or Fishers exact test will be used as appropriate Two-tailed p values of 005 will be considered statistically significant
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