Early Confirmation of Epidural CatheterizationNCT02838056
Early Detection of Epidural Onset by Temperature Change
A study testing epidural injection in people with Early Confirmation of Epidural Catheterization, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Traditionally, placement of the epidural catheter is based on hand feel of passing through the ligamentum flavum as well as "loss of resistance" while injecting the air through the needle. However, both are subjective and not necessarily encountered consistently. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Early Confirmation of Epidural Catheterization
- What is being tested?
- epidural injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Feb 2017to Sep 2017
- 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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body weight:50-90kg,
- American Society of Anesthesiologists physical status classification I-II,
- Under epidural anesthesia for surgery
Who cannot join
- History of receiving lumbar surgery
- Allergy to alfentanil ,xylocaine, bicarbonate
- Trauma
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Medical University/Wan Fang Hospital
Taipei
Sheng-Feng Yang, MD, +886229307930 ext. 2160, eclectec@hotmail.com
About this study
Official title: Early Detection of the Effect of Epidural Local Anesthetic by Temperature Change on the Big Toe
Traditionally, placement of the epidural catheter is based on hand feel of passing through the ligamentum flavum as well as "loss of resistance" while injecting the air through the needle. However, both are subjective and not necessarily encountered consistently. Moreover, the onset of sensory block is usually slow, thus making confirmation of catheter position a tough task and may delay the turnover of the operating room. The only way to confirm the catheter position objectively without delaying surgery is to find a reliable indicator within minutes of local anesthetic injection. In this study, we try to use the change of temperature in the big toe as a surrogate indicator of correct epidural catheterization.
Read the detailed description
Epidural anesthesia loading dose: 17ml 2% xylocaine + 2.3ml sodium bicarbonate + 2ml Rapifen (1088 mcg) + 0.1 mg epinephrine
- Being tested
- epidural injection
- Keywords
- anesthesia, epidural, skin temperature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural injectionDrug
drug combination: 2% lidocaine 17 ml + 2 ml alfentanil (544 mcg x 2 = 1088 mcg) + 7% sodium bicarbonate 2.3 ml (1.9 mEq) + 0.1mg epinephrine (1:200000)
| Study group | Role | What they receive |
|---|---|---|
| epidural injection | Experimental | epidural injection of 2% lidocaine 17 ml + 2 ml alfentanil (544 mcg x 2 = 1088 mcg) + 7% sodium bicarbonate 2.3 ml (1.9 mEq) + 0.1mg epinephrine (1:200000) Receives: Drug: epidural injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of skin temperature change over big toe after epidural local anesthetic injection
SPECTRUM 9000MB to detect lower limb color changes
Measured: within 10 mins after injection
Secondary outcomes (1)
measurement of skin sensation change between inguinal area to umbilicus
tested by alcohol sponge
Measured: within 15 mins after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study start21 Feb 2017
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
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 Early Confirmation of Epidural CatheterizationStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jui-An Lin, MD, Principal investigator, Taipei Medical University/Wan Fang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838056
- Sponsor's protocol ID
- 201505007
- Status last verified
- May 2016
- First submitted
- 12 Jul 2016
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cherng CH, Wong CS, Ho ST. Epidural fentanyl speeds the onset of sensory block during epidural lidocaine anesthesia. Reg Anesth Pain Med. 2001 Nov-Dec;26(6):523-6. doi: 10.1053/rapm.2001.27852.
PubMed 11707790Werdehausen R, Braun S, Hermanns H, Freynhagen R, Lipfert P, Stevens MF. Uniform distribution of skin-temperature increase after different regional-anesthesia techniques of the lower extremity. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):73-8. doi: 10.1016/j.rapm.2006.07.009.
PubMed 17196496Coda BA, Brown MC, Schaffer R, Donaldson G, Jacobson R, Hautman B, Shen DD. Pharmacology of epidural fentanyl, alfentanil, and sufentanil in volunteers. Anesthesiology. 1994 Nov;81(5):1149-61. doi: 10.1097/00000542-199411000-00008.
PubMed 7978473
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of the Effect of Epidural Local Anesthetic by Temperature Change on the Big Toe
- ClinicalTrials.gov ID
- NCT02838056
- Acronym / sponsor ID
- 201505007
- Keywords
- anesthesia, epidural, skin temperature
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 20 Jul 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.
Traditionally, placement of the epidural catheter is based on hand feel of passing through the ligamentum flavum as well as "loss of resistance" while injecting the air through the needle. However, both are subjective and not necessarily encountered consistently. Moreover, the onset of sensory block is usually slow, thus making confirmation of catheter position a tough task and may delay the turnover of the operating room. The only way to confirm the catheter position objectively without delaying surgery is to find a reliable indicator within minutes of local anesthetic injection. In this study, we try to use the change of temperature in the big toe as a surrogate indicator of correct epidural catheterization.
Detailed description
Epidural anesthesia loading dose: 17ml 2% xylocaine + 2.3ml sodium bicarbonate + 2ml Rapifen (1088 mcg) + 0.1 mg epinephrine
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| epidural injection | Experimental | Drug: epidural injectionepidural injection of 2% lidocaine 17 ml + 2 ml alfentanil (544 mcg x 2 = 1088 mcg) + 7% sodium bicarbonate 2.3 ml (1.9 mEq) + 0.1mg epinephrine (1:200000) |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body weight:50-90kg,
- American Society of Anesthesiologists physical status classification I-II,
- Under epidural anesthesia for surgery
Key exclusion criteria (3 listed)
- History of receiving lumbar surgery
- Allergy to alfentanil ,xylocaine, bicarbonate
- Trauma
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 |
|---|---|---|
| epidural injectiondrug combination: 2% lidocaine 17 ml + 2 ml alfentanil (544 mcg x 2 = 1088 mcg) + 7% sodium bicarbonate 2.3 ml (1.9 mEq) + 0.1mg epinephrine (1:200000) | Drug | epidural injection |
Primary outcome
measurement of skin temperature change over big toe after epidural local anesthetic injection
Time frame: within 10 mins after injection
SPECTRUM 9000MB to detect lower limb color changes
1 secondary outcome
measurement of skin sensation change between inguinal area to umbilicus
Time frame: within 15 mins after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Background: PubMed 11707790Cherng CH, Wong CS, Ho ST. Epidural fentanyl speeds the onset of sensory block during epidural lidocaine anesthesia. Reg Anesth Pain Med. 2001 Nov-Dec;26(6):523-6. doi: 10.1053/rapm.2001.27852.
- Background: PubMed 17196496Werdehausen R, Braun S, Hermanns H, Freynhagen R, Lipfert P, Stevens MF. Uniform distribution of skin-temperature increase after different regional-anesthesia techniques of the lower extremity. Reg Anesth Pain Med. 2007 Jan-Feb;32(1):73-8. doi: 10.1016/j.rapm.2006.07.009.
- Background: PubMed 7978473Coda BA, Brown MC, Schaffer R, Donaldson G, Jacobson R, Hautman B, Shen DD. Pharmacology of epidural fentanyl, alfentanil, and sufentanil in volunteers. Anesthesiology. 1994 Nov;81(5):1149-61. doi: 10.1097/00000542-199411000-00008.
- Individual participant dataSharing planned: Undecided
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.
Jui-An Lin, MD principal investigator
Taipei Medical University/Wan Fang 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 epidural injection in people with Early Confirmation of Epidural Catheterization, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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 3 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: status not confirmed, as of the sponsor's last update on 28 Feb 2017. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheng-Feng Yang, MD (+886229307930 ext. 2160, eclectec@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of skin temperature change over big toe after epidural local anesthetic injection (time frame: within 10 mins after injection). 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 NCT02838056, 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 28 Feb 2017.