AnesthesiaNCT02764502
Identification of Epidural Space Description of New Technique
A study testing Pressure Gauge Manometer in people with Anesthesia, run by Osama Ali Ibraheim at 1 site in Egypt.
Trial summary
Introduction Several attempts have been made to improve or facilitate epidural space detection beside conventional loss of resistant technique. Recently many sophisticated equipment's and techniques have been described which did not received widespread popularity. Read more about this study
- Who is it for?
- Ages 28 to 68 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Pressure Gauge Manometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2012to Apr 2014
- Phase
- Interventional
- 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 28 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA class 1\& II patients of ages between 28-68 years scheduled for elective surgery under lumber epidural anesthesia or under general anesthesia with planned post-operative epidural analgesia were enrolled in this study.
Who cannot join
- Patients with known coagulation disorder, allergy to local anesthetics, skin lesions at the puncture side, or neuromuscular disease were not included
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut University ,Faculty Of Medicine ,Anesthesia Department, Egypt
Asyut, Asyut Governorate, 71515
About this study
Introduction Several attempts have been made to improve or facilitate epidural space detection beside conventional loss of resistant technique. Recently many sophisticated equipment's and techniques have been described which did not received widespread popularity.
Objectives The Investigator describes and assesses the validity of using Pressure Gauge Manometer to confirm correct detection of lumber epidural space, in an inexpensive way.
Methods Tuohy needle is introduced into intervertebral space at the level of L3-L4 up to the interspinous ligaments ( nearly 2cm mark on the needle).A3-way stopcock is connected to the hub of Tuohy needle with the in-line port of the stopcock attached to an air-filled 10 ml syringe. Using a 75 cm extension tube set and create a 30 mm Hg pressure gradient between manometer and the tip of epidural needle , the needle is advanced slowly using both hands while monitoring the manometer reading and is stopped when the pressure suddenly dropped ( the pressure usually drops by 5-10 mm Hg when the tip of the needle inters the epidural space ).
Read the detailed description
- A total of 60 consecutive ASA class 1\& II patients of ages between 28-68 years scheduled for elective surgery under lumber epidural anesthesia or under general anesthesia with planned post-operative epidural analgesia were enrolled in this study.
Patients with known coagulation disorder, allergy to local anesthetics, skin lesions at the puncture side, or neuromuscular disease were not included.
Patients are placed in sitting position and American society of anesthesiologists standard monitors attached. After skin preparation, draping, and local anesthetic infiltration, an epidural Tuohy needle is introduced into intervertebral space at the level of L3-L4 up to the interspinous ligaments ( nearly 2cm mark on the needle). Fig 1 A3-way stopcock is connected to the hub of Tuohy needle with the in-line port of the stopcock attached to an air-filled 10 ml syringe. Using a 75 cm extension tube set the side port is connected to the Pressure Gauge Manometer held by the assistant. The stopcock is turned so that the needle is in direct continuity with both syringe and pressure Gage manometer. The syringe is used to create a 30 mm Hg pressure reading on the manometer, the stopcock then is turned into "open" to manometer and Tuohy needle and "close" to syringe.
With this 30 mm Hg pressure gradient between manometer and the tip of epidural needle, the needle is advanced slowly using both hands while monitoring the manometer reading and is stopped when the pressure changes ( the pressure usually drops by 5-10 mm Hg when the tip of the needle inters the epidural space ).
The 3-way is then removed and local anesthetic is injected for single shot epidural block or catheter is introduced in the conventional manner and secured by adhesive tap.
Procedure was performed by anesthetists of different levels of experience (consultant, specialist, resident).
Demographic data and type of surgery is recorded along with time of the technique, number of passes required to enter the epidural space, any false LOR, insertion difficulties, accidental dural puncture, or any other complication occurred.
- Conditions
- Anesthesia
- Being tested
- Pressure Gauge Manometer
- Keywords
- Epidural Identification pressure gauge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressure Gauge ManometerDevice
Identification of epidural space
| Study group | Role | What they receive |
|---|---|---|
| Pressure Gauge Manometer | Experimental | Tuohy needle is introduced into intervertebral space at the level of L3-L4 up to the interspinous ligaments . The needle is advanced slowly using both hands while monitoring the manometer reading and is stopped when the pressure suddenly dropped ( the pressure usually drops by 5-10 mm Hg when the tip of the needle inters the epidural space ). Receives: Device: Pressure Gauge Manometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of the technique.
For epidural catheter placement success of the technique is defined as the installation of sensory block after the end of surgery.
Measured: 10 minutes after the technique.
Secondary outcomes (1)
The physician satisfaction with the technique (Definitely not, Not completely, Yes)
Measured: 12hours after the end of the technique
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startMar 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osama Ali Ibraheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Osama Ali Ibraheim, Assiut University
- Investigators
- Osama A Ibraheim, MD, Principal investigator, Assiut University College of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764502
- Sponsor's protocol ID
- 010007
- Status last verified
- May 2016
- First submitted
- 10 Apr 2016
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Epidural Space Description of New Technique
- ClinicalTrials.gov ID
- NCT02764502
- Acronym / sponsor ID
- 010007
- Conditions
- Anesthesia
- Keywords
- Epidural Identification pressure gauge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Osama Ali IbraheimUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 6 May 2016 (estimated)
- 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.
Introduction Several attempts have been made to improve or facilitate epidural space detection beside conventional loss of resistant technique. Recently many sophisticated equipment's and techniques have been described which did not received widespread popularity.
Objectives The Investigator describes and assesses the validity of using Pressure Gauge Manometer to confirm correct detection of lumber epidural space, in an inexpensive way.
Methods Tuohy needle is introduced into intervertebral space at the level of L3-L4 up to the interspinous ligaments ( nearly 2cm mark on the needle).A3-way stopcock is connected to the hub of Tuohy needle with the in-line port of the stopcock attached to an air-filled 10 ml syringe. Using a 75 cm extension tube set and create a 30 mm Hg pressure gradient between manometer and the tip of epidural needle , the needle is advanced slowly using both hands while monitoring the manometer reading and is stopped when the pressure suddenly dropped ( the pressure usually drops by 5-10 mm Hg when the tip of the needle inters the epidural space ).
Detailed description
- A total of 60 consecutive ASA class 1\& II patients of ages between 28-68 years scheduled for elective surgery under lumber epidural anesthesia or under general anesthesia with planned post-operative epidural analgesia were enrolled in this study.
Patients with known coagulation disorder, allergy to local anesthetics, skin lesions at the puncture side, or neuromuscular disease were not included.
Patients are placed in sitting position and American society of anesthesiologists standard monitors attached. After skin preparation, draping, and local anesthetic infiltration, an epidural Tuohy needle is introduced into intervertebral space at the level of L3-L4 up to the interspinous ligaments ( nearly 2cm mark on the needle). Fig 1 A3-way stopcock is connected to the hub of Tuohy needle with the in-line port of the stopcock attached to an air-filled 10 ml syringe. Using a 75 cm extension tube set the side port is connected to the Pressure Gauge Manometer held by the assistant. The stopcock is turned so that the needle is in direct continuity with both syringe and pressure Gage manometer. The syringe is used to create a 30 mm Hg pressure reading on the manometer, the stopcock then is turned into "open" to manometer and Tuohy needle and "close" to syringe.
With this 30 mm Hg pressure gradient between manometer and the tip of epidural needle, the needle is advanced slowly using both hands while monitoring the manometer reading and is stopped when the pressure changes ( the pressure usually drops by 5-10 mm Hg when the tip of the needle inters the epidural space ).
The 3-way is then removed and local anesthetic is injected for single shot epidural block or catheter is introduced in the conventional manner and secured by adhesive tap.
Procedure was performed by anesthetists of different levels of experience (consultant, specialist, resident).
Demographic data and type of surgery is recorded along with time of the technique, number of passes required to enter the epidural space, any false LOR, insertion difficulties, accidental dural puncture, or any other complication occurred.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pressure Gauge Manometer | Experimental | Device: Pressure Gauge ManometerTuohy needle is introduced into intervertebral space at the level of L3-L4 up to the interspinous ligaments . The needle is advanced slowly using both hands while monitoring the manometer reading and is stopped when the pressure suddenly dropped ( the pressure usually drops by 5-10 mm Hg when the tip of the needle inters the epidural space ). |
Who may qualify
- Ages
- 28 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA class 1\& II patients of ages between 28-68 years scheduled for elective surgery under lumber epidural anesthesia or under general anesthesia with planned post-operative epidural analgesia were enrolled in this study.
Key exclusion criteria (1 listed)
- Patients with known coagulation disorder, allergy to local anesthetics, skin lesions at the puncture side, or neuromuscular disease were not included
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 |
|---|---|---|
| Pressure Gauge ManometerIdentification of epidural space | Device | Pressure Gauge Manometer |
Primary outcome
Success of the technique.
Time frame: 10 minutes after the technique.
For epidural catheter placement success of the technique is defined as the installation of sensory block after the end of surgery.
1 secondary outcome
The physician satisfaction with the technique (Definitely not, Not completely, Yes)
Time frame: 12hours after the end of the technique
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 6 May 2016.
- Individual participant dataSharing planned: Yes
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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.
Osama A Ibraheim, MD principal investigator
Assiut University College of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressure Gauge Manometer in people with Anesthesia, run by Osama Ali Ibraheim 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 1 inclusion and 1 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 6 May 2016. 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?
Success of the technique. (time frame: 10 minutes after the technique.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2016.