Labor PainNCT00996905
Does Ultrasound Scanning of the Lumbar Spine Improve Patient Satisfaction and the Ease of Insertion Epidurals?
A study testing Portable ultrasound machine in people with Labor Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Ultrasound scanning of the back has been shown to increase success when used to guide epidural catheter insertion. However, this technique is not applied widely in clinical practice. Stronger evidence is required to prove that it will improve the clinical experience of labour epidurals. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain
- What is being tested?
- Portable ultrasound machine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2009to Oct 2010
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ability to Speak in English
- requesting epidural analgesia for labour
- having easily palpable spine (clinically 'easy' back)
- Residents and fellows training or practicing at Mount Sinai hospital and enrolled in either a residency or fellowship program at the University of Toronto.
Who cannot join
- contraindications to epidural analgesia
- patients with a history of difficult epidural insertions or spinal anesthetic
- Patients with a known history of back surgery
- patients with known significant kyph0scoliosis
- For Anesthesiologists:
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Ultrasound Scanning of the Lumbar Spine Improve Patient Satisfaction and the Ease of Insertion of Labour Epidural Catheters
Ultrasound scanning of the back has been shown to increase success when used to guide epidural catheter insertion. However, this technique is not applied widely in clinical practice. Stronger evidence is required to prove that it will improve the clinical experience of labour epidurals.
The study hypothesis is that anesthesiologists (both residents and fellows), will have an increased rate of success and ease of insertion of labour epidural catheters, and that there will be increased patient satisfaction, if ultrasound scanning of the lumbar spine is done prior to the procedure.
Read the detailed description
Studies have shown that ultrasound scanning of the lumbar spine is beneficial in certain circumstances (eg. predicted difficult epidurals). However, no large scale studies with multiple anesthesiologists performing the technique have been done to show that ultrasound scanning may be of benefit in their everyday clinical practice.
This study will involve residents and fellows, each performing epidural insertions with and without the use of ultrasound scanning of the lumbar spine prior to the procedure. If the hypothesis is correct, then the use of this technique may become widespread, resulting in less complications and increased patients satisfaction.
- Conditions
- Labor Pain
- Being tested
- Portable ultrasound machine
- Keywords
- Epidural Analgesia, Ultrasound, Training, Inservice
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable ultrasound machineDevice
Each patient will have their lumbar spine scanned by ultrasound for a maximum period of 5 minutes.
Portable ultrasound machineDevice
Each patient will have their lumbar spine scanned by ultrasound for a maximum period of 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Beginner Conventional (BC) | No intervention | Beginner level (residents) doing epidural insertions the conventional way (ie. no ultrasound scanning) |
| Beginner Ultrasound (BU) | Experimental | Beginner level (residents) doing epidural insertions with the help of ultrasound scanning. Receives: Device: Portable ultrasound machine |
| Experienced Conventional | No intervention | Experienced level (fellows) doing epidural insertions the conventional way. |
| Experienced Ultrasound | Experimental | Experienced level (fellows) doing epidural insertions with the help of ultrasound scanning. Receives: Device: Portable ultrasound machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of epidural insertion by the following 3 measurements: time to perform procedure (minutes), number of levels at which insertion is attempted, and number of ventral passes of the epidural needle.
Measured: 20 minutes
Secondary outcomes (5)
The occurrence of inadvertent dural punctures.
Measured: 24-48 hours
Number of attempts to thread the epidural catheter
Measured: 20 minutes
Success or failure of the epidural (defined as lack of sufficient analgesia within 2 hours of insertion, necessitating re-insertion)
Measured: 2 hours
The need of the anesthesiologist to call for assistance with the procedure
Measured: 30 minutes
Patient satisfaction as determine by a questionnaire
Measured: 24 hours and 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jose CA Carvalho, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996905
- Sponsor's protocol ID
- 09-02
- Status last verified
- Feb 2011
- First submitted
- 15 Oct 2009
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Arzola C, Mikhael R, Margarido C, Carvalho JC. Spinal ultrasound versus palpation for epidural catheter insertion in labour: A randomised controlled trial. Eur J Anaesthesiol. 2015 Jul;32(7):499-505. doi: 10.1097/EJA.0000000000000119.
PubMed 25036283
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Ultrasound Scanning of the Lumbar Spine Improve Patient Satisfaction and the Ease of Insertion of Labour Epidural Catheters
- ClinicalTrials.gov ID
- NCT00996905
- Acronym / sponsor ID
- 09-02
- Conditions
- Labor Pain
- Keywords
- Epidural Analgesia, Ultrasound, Training, Inservice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Oct 2009 (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.
Ultrasound scanning of the back has been shown to increase success when used to guide epidural catheter insertion. However, this technique is not applied widely in clinical practice. Stronger evidence is required to prove that it will improve the clinical experience of labour epidurals.
The study hypothesis is that anesthesiologists (both residents and fellows), will have an increased rate of success and ease of insertion of labour epidural catheters, and that there will be increased patient satisfaction, if ultrasound scanning of the lumbar spine is done prior to the procedure.
Detailed description
Studies have shown that ultrasound scanning of the lumbar spine is beneficial in certain circumstances (eg. predicted difficult epidurals). However, no large scale studies with multiple anesthesiologists performing the technique have been done to show that ultrasound scanning may be of benefit in their everyday clinical practice.
This study will involve residents and fellows, each performing epidural insertions with and without the use of ultrasound scanning of the lumbar spine prior to the procedure. If the hypothesis is correct, then the use of this technique may become widespread, resulting in less complications and increased patients satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Beginner Conventional (BC) | No intervention | –Beginner level (residents) doing epidural insertions the conventional way (ie. no ultrasound scanning) |
| Beginner Ultrasound (BU) | Experimental | Device: Portable ultrasound machineBeginner level (residents) doing epidural insertions with the help of ultrasound scanning. |
| Experienced Conventional | No intervention | –Experienced level (fellows) doing epidural insertions the conventional way. |
| Experienced Ultrasound | Experimental | Device: Portable ultrasound machineExperienced level (fellows) doing epidural insertions with the help of ultrasound scanning. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ability to Speak in English
- requesting epidural analgesia for labour
- having easily palpable spine (clinically 'easy' back)
- Residents and fellows training or practicing at Mount Sinai hospital and enrolled in either a residency or fellowship program at the University of Toronto.
Key exclusion criteria (5 listed)
- contraindications to epidural analgesia
- patients with a history of difficult epidural insertions or spinal anesthetic
- Patients with a known history of back surgery
- patients with known significant kyph0scoliosis
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 |
|---|---|---|
| Portable ultrasound machineEach patient will have their lumbar spine scanned by ultrasound for a maximum period of 5 minutes. | Device | Beginner Ultrasound (BU) |
| Portable ultrasound machineEach patient will have their lumbar spine scanned by ultrasound for a maximum period of 5 minutes. | Device | Experienced Ultrasound |
Primary outcome
Ease of epidural insertion by the following 3 measurements: time to perform procedure (minutes), number of levels at which insertion is attempted, and number of ventral passes of the epidural needle.
Time frame: 20 minutes
5 secondary outcomes
The occurrence of inadvertent dural punctures.
Time frame: 24-48 hours
Number of attempts to thread the epidural catheter
Time frame: 20 minutes
Success or failure of the epidural (defined as lack of sufficient analgesia within 2 hours of insertion, necessitating re-insertion)
Time frame: 2 hours
The need of the anesthesiologist to call for assistance with the procedure
Time frame: 30 minutes
Patient satisfaction as determine by a questionnaire
Time frame: 24 hours and 1 week
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 23 Feb 2011.
- Derived from this study: PubMed 25036283Arzola C, Mikhael R, Margarido C, Carvalho JC. Spinal ultrasound versus palpation for epidural catheter insertion in labour: A randomised controlled trial. Eur J Anaesthesiol. 2015 Jul;32(7):499-505. doi: 10.1097/EJA.0000000000000119.
Related trials for Labor Pain
Recruiting
The Effect Of Partner-Assısted Rebozo Technıque On Labor Paın And Satısfactıon In Prımary Pregnant Women
Labor Pains
RecruitingPhase 4
Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
Labor Pain
Not yet recruiting
Pre-Examination Reflexology for Anxiety and Pain During Pelvic Examination
Anxiety
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
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.
Jose CA Carvalho, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable ultrasound machine in people with Labor Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
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 5 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 23 Feb 2011. 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 Canada. 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?
Ease of epidural insertion by the following 3 measurements: time to perform procedure (minutes), number of levels at which insertion is attempted, and number of ventral passes of the epidural needle. (time frame: 20 minutes). 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 NCT00996905, which also lists 1 linked publication.
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 23 Feb 2011.