PainNCT00792311
Tsui Test as a Predictor of Bupivacaine Consumption in Labour Epidurals
A study testing Tsui test in people with Pain, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial summary
Low current electrical stimulation test, also called the Tsui test, has been used successfully to confirm the catheter location in the epidural space in various patient populations. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Tsui test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2008to Aug 2009
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women over 18 years of age requesting an epidural for labor and delivery
- Cervix dilated 0-5 cm and pain VAS>6
- Able to communicate in English
- Informed consent
Who cannot join
- Refusal to provide written informed consent
- Patients unable to communicate in English
- Contraindication to regional anesthesia
- Allergy or hypersensitivity to lidocaine, bupivacaine or fentanyl
- Sedatives or opioids received prior to insertion of epidural catheter
- Abnormal vertebral anatomy, such as previous spine surgery and scoliosis
- Coexisting neurological disorders
- Patients with implanted electronic devices
Trial locations and contacts
1 site in 1 country.
About this study
Low current electrical stimulation test, also called the Tsui test, has been used successfully to confirm the catheter location in the epidural space in various patient populations. The results of this study will show whether or not doing a Tsui test can predict inadequate epidural analgesia early in the course of placing the epidural, so that the appropriate measures could be applied immediately upon gathering unfavorable results.
Read the detailed description
Despite its very high success rate, the epidural technique remains a rather blind technique, and failures continue to occur. The incidence and reasons for failure are not well understood. The Tsui test is not routinely performed with each epidural catheter insertion, but rather it is used when there is suspicion about the catheter location.
In this study, the Tsui test will be performed twice during the epidural procedure, and bupivacaine consumption will be recorded for the first 2 hours.
Information gained from this study could have great impact in clinical practice, since the incidence of inadequate labor analgesia is still relatively high (10-20%), leading to maternal distress and disappointing labor experience.
- Conditions
- Pain
- Being tested
- Tsui test
- Keywords
- Tsui test, Epidural Analgesia
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tsui testProcedure or surgery
The stimulator is set at frequency of 1Hz with 200ms pulse width and the current output ranging from 0 to 20 mA. The current output will be carefully increased from zero until motor activity is detected up to a maximum of 20 mA.
| Study group | Role | What they receive |
|---|---|---|
| Tsui test | Experimental | Tsui test administration. Receives: Procedure: Tsui test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consumption of bupivacaine in mg/hour in the first 2 hours of epidural anesthesia
Measured: 2 hours
Secondary outcomes (3)
Incidence of inadequate epidural block.
Measured: 2 hours
Current (mA) needed to elicit motor response; 1. before test dose and 2. 5 minutes after test dose.
Measured: 5 minutes
Contraction pattern elicited by the Tsui test at baseline and after test dose.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 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
- NCT00792311
- Sponsor's protocol ID
- 08-02
- Status last verified
- Mar 2010
- First submitted
- 13 Nov 2008
- Last updated
- 26 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tsui Test as a Predictor of Bupivacaine Consumption in Labour Epidurals
- ClinicalTrials.gov ID
- NCT00792311
- Acronym / sponsor ID
- 08-02
- Conditions
- Pain
- Keywords
- Tsui test, Epidural Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 17 Nov 2008 (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.
Low current electrical stimulation test, also called the Tsui test, has been used successfully to confirm the catheter location in the epidural space in various patient populations. The results of this study will show whether or not doing a Tsui test can predict inadequate epidural analgesia early in the course of placing the epidural, so that the appropriate measures could be applied immediately upon gathering unfavorable results.
Detailed description
Despite its very high success rate, the epidural technique remains a rather blind technique, and failures continue to occur. The incidence and reasons for failure are not well understood. The Tsui test is not routinely performed with each epidural catheter insertion, but rather it is used when there is suspicion about the catheter location.
In this study, the Tsui test will be performed twice during the epidural procedure, and bupivacaine consumption will be recorded for the first 2 hours.
Information gained from this study could have great impact in clinical practice, since the incidence of inadequate labor analgesia is still relatively high (10-20%), leading to maternal distress and disappointing labor experience.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tsui test | Experimental | Procedure: Tsui testTsui test administration. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women over 18 years of age requesting an epidural for labor and delivery
- Cervix dilated 0-5 cm and pain VAS>6
- Able to communicate in English
- Informed consent
Key exclusion criteria (8 listed)
- Refusal to provide written informed consent
- Patients unable to communicate in English
- Contraindication to regional anesthesia
- Allergy or hypersensitivity to lidocaine, bupivacaine or fentanyl
- Sedatives or opioids received prior to insertion of epidural catheter
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 |
|---|---|---|
| Tsui testThe stimulator is set at frequency of 1Hz with 200ms pulse width and the current output ranging from 0 to 20 mA. The current output will be carefully increased from zero until motor activity is detected up to a maximum of 20 mA. | Procedure or surgery | Tsui test |
Primary outcome
Consumption of bupivacaine in mg/hour in the first 2 hours of epidural anesthesia
Time frame: 2 hours
3 secondary outcomes
Incidence of inadequate epidural block.
Time frame: 2 hours
Current (mA) needed to elicit motor response; 1. before test dose and 2. 5 minutes after test dose.
Time frame: 5 minutes
Contraction pattern elicited by the Tsui test at baseline and after test dose.
Time frame: 5 minutes
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 Mar 2010.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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 Tsui test in people with 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 8 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 Mar 2010. 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?
Consumption of bupivacaine in mg/hour in the first 2 hours of epidural anesthesia (time frame: 2 hours). 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 26 Mar 2010.