Uterine DiseasesNCT06019039
Power Doppler Ultrasonography in Localization of Epidural Catheter
An observational study of Uterine Diseases, run by Yasser S Mostafa, MD at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years, women only
- Conditions the study is for
- Uterine Diseases
- What is being tested?
- Normal Saline Flush and Doppler
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 15 Mar 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Primary gynecology and obstetric care clinic in Fayoum university hospital
Who may be able to join
- Women who will have hysterectomy operation under epidural analgesia
- Women with the epidural catheter still in place
- American Society of Anesthesiologists (ASA) physical status I, II
- Age range from 30 and 70 years.
Who cannot join
- Patient refusal
- History of allergy to one of the study drugs.
- Any contraindication to regional anesthesia such as local infection or bleeding disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Power Doppler Ultrasonography in Localization of Epidural Catheter : an Observational Prospective Study
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.
Read the 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 kg/m2, 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., Melsungen,AG, 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 (SONOTAP,Pajunk,Geisingen,Germany 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 3.1.7 (Institute of experimental psychology, Heinrich Heine University, Dusseldorf, Germany).Minimal sample size of patients was (60) patients. Effect size 0.47 Depending on previous research results. Two tailed type I error 0.05 and power of 80%.
Statistical analysis will be performed using SPSS version 24.0 (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 Fisher's exact test will be used as appropriate. Two-tailed p values of 0.05 will be considered statistically significant.
- Conditions
- Uterine Diseases
- Being tested
- Normal Saline Flush, Doppler
- Keywords
- Power doppler ultrasonography, Epidural catheter, Hysterectomy
- Medical subject headings
- Uterine Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Saline FlushDrug
Also called 0.9% isotonic normal saline
Five milliliters of sterile saline will be administered as a flush through the needle while recording the color flow doppler images. The same procedure will be repeated with a slow injection of 5 mL of saline. The speed of injection will not be standardized.
DopplerDevice
Also called Color flow Doppler
All color flow Doppler images will be performed with a Phillips CX50 ultrasound machine using a 5.0 MHz a low frequency curvilinear US probe. A two-dimensional transverse interspinous view was used to visualize the posterior complex (ligamentum flavum, epidural space and dura). After loss of resistance to normal saline, the color flow Doppler 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 .
| Study group | Role | What they receive |
|---|---|---|
| Epidural Ultrasound group | After placement of the epidural catheter, parasagittal and transverse views with CFD will be obtained to identify location of the catheter within the epidural space. Two levels above and below the insertion site will be used to locate the epidural catheter. Receives: Drug: Normal Saline Flush; Device: Doppler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization of flow relative to the interspace insertion level by color flow Doppler
Yes or no
Measured: 1 minute after insertion of epidural catheter
Secondary outcomes (6)
Level of epidural catheter insertion
From Lumbar level 1 to 5
Measured: 1 minute after insertion of epidural catheter
Verbal numerical rating scale
0-10 where 0: no pain and 10:worst pain
Measured: 8 hours postoperatively
Duration of epidural analgesia
in hours
Measured: First 24 hours postoperatively.
Incidence of patchy or asymmetric block
Yes or no
Measured: 15 minutes after insertion of epidural catheter
Maximum upper sensory block to ice as charted by the nurse
Dermatomal level thoracic level 10 up to umbilicus
Measured: 15 minutes after insertion of epidural catheter
Intervertebral level at which the epidural catheter is inserted
From Lumbar level 2-3 or 3-4
Measured: 1 minute after insertion of epidural catheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Apr 2023
- Primary completion15 Feb 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uterine DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Yasser S Mostafa, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Fayoum University Hospital
- Responsible party
- Sponsor-investigator, Yasser S Mostafa, MD, Fayoum University Hospital
- Investigators
- Atef M Sayed, MD, Principal investigator, Fayoum UniversityAbeer S Goda, MD, Study director, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019039
- Sponsor's protocol ID
- m649
- Status last verified
- Oct 2024
- First submitted
- 15 Aug 2023
- Last updated
- 26 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu Y, He S, Zhou S. Effect of general anesthesia combined with epidural anesthesia on circulation and stress response of patients undergoing hysterectomy. Am J Transl Res. 2021 May 15;13(5):5294-5300. eCollection 2021.
PubMed 34150121Elsharkawy H, Sonny A, Chin KJ. Localization of epidural space: A review of available technologies. J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):16-27. doi: 10.4103/0970-9185.202184.
PubMed 28413269Riveros-Perez E, Albo C, Jimenez E, Cheriyan T, Rocuts A. Color your epidural: color flow Doppler to confirm labor epidural needle position. Minerva Anestesiol. 2019 Apr;85(4):376-383. doi: 10.23736/S0375-9393.18.13175-0. Epub 2018 Nov 22.
PubMed 30482003
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Power Doppler Ultrasonography in Localization of Epidural Catheter : an Observational Prospective Study
- ClinicalTrials.gov ID
- NCT06019039
- Acronym / sponsor ID
- m649
- Conditions
- Uterine Diseases
- Keywords
- Power doppler ultrasonography, Epidural catheter, Hysterectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yasser S Mostafa, MDUniversity, hospital or other
- Collaborators
- Fayoum University Hospital
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 31 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 kg/m2, 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., Melsungen,AG, 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 (SONOTAP,Pajunk,Geisingen,Germany 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 3.1.7 (Institute of experimental psychology, Heinrich Heine University, Dusseldorf, Germany).Minimal sample size of patients was (60) patients. Effect size 0.47 Depending on previous research results. Two tailed type I error 0.05 and power of 80%.
Statistical analysis will be performed using SPSS version 24.0 (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 Fisher's exact test will be used as appropriate. Two-tailed p values of 0.05 will be considered statistically significant.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidural Ultrasound group | – | Drug: Normal Saline Flush, Device: DopplerAfter placement of the epidural catheter, parasagittal and transverse views with CFD will be obtained to identify location of the catheter within the epidural space. Two levels above and below the insertion site will be used to locate the epidural catheter. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary gynecology and obstetric care clinic in Fayoum university hospital
Key inclusion criteria (4 listed)
- Women who will have hysterectomy operation under epidural analgesia
- Women with the epidural catheter still in place
- American Society of Anesthesiologists (ASA) physical status I, II
- Age range from 30 and 70 years.
Key exclusion criteria (3 listed)
- Patient refusal
- History of allergy to one of the study drugs.
- Any contraindication to regional anesthesia such as local infection or bleeding disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal Saline FlushAlso: 0.9% isotonic normal salineFive milliliters of sterile saline will be administered as a flush through the needle while recording the color flow doppler images. The same procedure will be repeated with a slow injection of 5 mL of saline. The speed of injection will not be standardized. | Drug | Epidural Ultrasound group |
| DopplerAlso: Color flow DopplerAll color flow Doppler images will be performed with a Phillips CX50 ultrasound machine using a 5.0 MHz a low frequency curvilinear US probe. A two-dimensional transverse interspinous view was used to visualize the posterior complex (ligamentum flavum, epidural space and dura). After loss of resistance to normal saline, the color flow Doppler 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 . | Device | Epidural Ultrasound group |
Primary outcome
Visualization of flow relative to the interspace insertion level by color flow Doppler
Time frame: 1 minute after insertion of epidural catheter
Yes or no
6 secondary outcomes
Level of epidural catheter insertion
Time frame: 1 minute after insertion of epidural catheter
Verbal numerical rating scale
Time frame: 8 hours postoperatively
Duration of epidural analgesia
Time frame: First 24 hours postoperatively.
Incidence of patchy or asymmetric block
Time frame: 15 minutes after insertion of epidural catheter
Maximum upper sensory block to ice as charted by the nurse
Time frame: 15 minutes after insertion of epidural catheter
Intervertebral level at which the epidural catheter is inserted
Time frame: 1 minute after insertion of epidural catheter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Background: PubMed 34150121Liu Y, He S, Zhou S. Effect of general anesthesia combined with epidural anesthesia on circulation and stress response of patients undergoing hysterectomy. Am J Transl Res. 2021 May 15;13(5):5294-5300. eCollection 2021.
- Background: PubMed 28413269Elsharkawy H, Sonny A, Chin KJ. Localization of epidural space: A review of available technologies. J Anaesthesiol Clin Pharmacol. 2017 Jan-Mar;33(1):16-27. doi: 10.4103/0970-9185.202184.
- Background: PubMed 30482003Riveros-Perez E, Albo C, Jimenez E, Cheriyan T, Rocuts A. Color your epidural: color flow Doppler to confirm labor epidural needle position. Minerva Anestesiol. 2019 Apr;85(4):376-383. doi: 10.23736/S0375-9393.18.13175-0. Epub 2018 Nov 22.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atef M Sayed, MD principal investigator
Fayoum University
Abeer S Goda, MD study director
Fayoum University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Diseases, run by Yasser S Mostafa, MD at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization of flow relative to the interspace insertion level by color flow Doppler (time frame: 1 minute after insertion of epidural catheter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06019039, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.