Labor PainNCT01182220
Comparison of Ultrasound Guided Low Epidural Catheter Placement With Standard Epidural Catheter Placement
An observational study of Labor Pain, run by University of Chicago at 1 site in United States.
Trial summary
1. labor epidural quite often require bolus supplementation for better pain control control. Quite often this is due to sparing of sacral nerves. 2. If epidural is placed low in the L5/S1 interspace using ultrasound, this may minimize bolus requirement and improve patient labor experience. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Labor Pain
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jul 2015
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: active laboring patient without any complication requesting epdiural for pain control
Who may be able to join
- Active labor age 18 or older
Who cannot join
- Known contraindications to epidural analgesia
- Any neurologic illness
- Fetal abnormalities
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Hospitals
Chicago, Illinois, 60637
About this study
Official title: Comparison of Ultrasound Guided L5/S1 Epidural Catheter Placement With Standard Epidural Catheter Placement: A Randomized Trial
- labor epidural quite often require bolus supplementation for better pain control control. Quite often this is due to sparing of sacral nerves.
- If epidural is placed low in the L5/S1 interspace using ultrasound, this may minimize bolus requirement and improve patient labor experience.
Read the detailed description
After consent patients will be randomized to one of the two groups: Control Group or the Experimental Group. Patients will be blinded to the group assignment.
In each subject prior to labor epidural placement, intravenous access will be obtained and if indicated fluid bolus will be given. There after heart and lung monitors will be placed. Procedure will be placed in sitting position. Standard epidural kit will be used.
In the Control Group the patient will be seated. Low back area will be prepped and draped in a sterile fashion. Lumbar interspaces will be identified clinically and epidural catheter will be inserted in the interspace deemed most appropriate. Epidural space will be accessed using loss of resistance to air technique. Once identified, a 20g open tip catheter will be placed can into the space.
In the Experimental Group, subjects back will be scanned with an Ultrasound probe. The interspace L5/S1, the lowest interspace in the spine will be identified and marked with the marker on the skin. Thereafter epidural catheter will be place using the exactly the same technique as used in the control group.
Once in place, catheter will be aspirated to rule out any intravascular placement. Thereafter a test dose composed of 45 mg lidocaine and 15 microgram epinephrine will be injected via the catheter to rule out any misplacement of catheter either in the intrathecal space or blood vessels. Once proper placement confirmed, catheter will be dose with 10 ml 0.25% bupivacaine in 5 ml boluses.
The extent of block before the surgery will be evaluated at 30 minutes post injection. Dermatomal level will be assessed on each side using ice. S1 and S2 dermatomal blockage will be specifically assessed on each side by testing lateral margin of each foot (S1 dermatome) and medial side of the popliteal fossa ( S2 dermatome).
Thereafter catheter will be connected to epidural solution containing 0.1% bupivacaine and 2 mic of Fentanyl per ml. Starting dose will be 10 ml per hr with bolus dose 5 ml q 30 minutes self administered by patient if needed.
If pain relief is inadequate top-up doses will be given consisting of 5 ml 0.25% bupivacaine times two 20 minutes part if needed. If no relief, dermatomal level will be reassessed. If ones sided or unequal, catheter will be pulled back I-2 cm and re-dosed with bupivacaine 0.25% 5 ml times two if needed over twenty minutes. If still no relief and inadequate level, catheter will be replaced.
Epidural catheter will be left in place till delivery. Patients will be clinically monitored as part of routine anesthetic management. Once they deliver catheter is removed by nurses in the labor and delivery unit and patients are sent to floor for recovery. Last evaluation will take place on post delivery day number one to evaluate patient satisfaction and address any concern patients may have.
Primary End points:
Primary purpose is to assess the ability of L5/S1 catheter to numb S1 or S2 dermatomes in comparison to routine placement of epidural catheter Secondary outcome to be assessed VAS, catheter manipulation or replacement between the two groups.
- Conditions
- Labor Pain
- Keywords
- epidural, labor pain, ultrasound
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound L5/S1 catheter placement | Pt will have back scanned with Ultrasound and L5/S1 interspace localized for epidural placement. | |
| Control Group | Patients will have catheter placed after clinically evaluating the back as is done routinely resulting in mid lumbar catheter placement in general. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1.Blocking of S1 and S2 dermatomes
After test dose and loading up of catheter, s1 and s2 dermatome blockage will be tested in L5/S1 epidural group vs conventionally placed epidural group. Idea is see if higher incidence of S1 and S2 blockage can be demonstrated in low epidural group.
Measured: 30 minutes after loading epidural
Secondary outcomes (2)
Number of top up doses for pain control throughout labor
Better blocking of sacral dermatome should improve pain control and should result in clinically significant lower number of boluses.
Measured: from insertion till delivery average 8-24 hrs
Patient satisfaction
Improved pain control and less number of boluses should translate into better patient satisfaction
Measured: Evaluated on Post deliver day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2010 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TARIQ MALIK, MD, Principal investigator, University of ChicagoMohammed Minhaj, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182220
- Sponsor's protocol ID
- 10-241-B
- Status last verified
- Oct 2016
- First submitted
- 10 May 2010
- Last updated
- 1 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound Guided L5/S1 Epidural Catheter Placement With Standard Epidural Catheter Placement: A Randomized Trial
- ClinicalTrials.gov ID
- NCT01182220
- Acronym / sponsor ID
- 10-241-B
- Conditions
- Labor Pain
- Keywords
- epidural, labor pain, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 16 Aug 2010 (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.
- labor epidural quite often require bolus supplementation for better pain control control. Quite often this is due to sparing of sacral nerves.
- If epidural is placed low in the L5/S1 interspace using ultrasound, this may minimize bolus requirement and improve patient labor experience.
Detailed description
After consent patients will be randomized to one of the two groups: Control Group or the Experimental Group. Patients will be blinded to the group assignment.
In each subject prior to labor epidural placement, intravenous access will be obtained and if indicated fluid bolus will be given. There after heart and lung monitors will be placed. Procedure will be placed in sitting position. Standard epidural kit will be used.
In the Control Group the patient will be seated. Low back area will be prepped and draped in a sterile fashion. Lumbar interspaces will be identified clinically and epidural catheter will be inserted in the interspace deemed most appropriate. Epidural space will be accessed using loss of resistance to air technique. Once identified, a 20g open tip catheter will be placed can into the space.
In the Experimental Group, subjects back will be scanned with an Ultrasound probe. The interspace L5/S1, the lowest interspace in the spine will be identified and marked with the marker on the skin. Thereafter epidural catheter will be place using the exactly the same technique as used in the control group.
Once in place, catheter will be aspirated to rule out any intravascular placement. Thereafter a test dose composed of 45 mg lidocaine and 15 microgram epinephrine will be injected via the catheter to rule out any misplacement of catheter either in the intrathecal space or blood vessels. Once proper placement confirmed, catheter will be dose with 10 ml 0.25% bupivacaine in 5 ml boluses.
The extent of block before the surgery will be evaluated at 30 minutes post injection. Dermatomal level will be assessed on each side using ice. S1 and S2 dermatomal blockage will be specifically assessed on each side by testing lateral margin of each foot (S1 dermatome) and medial side of the popliteal fossa ( S2 dermatome).
Thereafter catheter will be connected to epidural solution containing 0.1% bupivacaine and 2 mic of Fentanyl per ml. Starting dose will be 10 ml per hr with bolus dose 5 ml q 30 minutes self administered by patient if needed.
If pain relief is inadequate top-up doses will be given consisting of 5 ml 0.25% bupivacaine times two 20 minutes part if needed. If no relief, dermatomal level will be reassessed. If ones sided or unequal, catheter will be pulled back I-2 cm and re-dosed with bupivacaine 0.25% 5 ml times two if needed over twenty minutes. If still no relief and inadequate level, catheter will be replaced.
Epidural catheter will be left in place till delivery. Patients will be clinically monitored as part of routine anesthetic management. Once they deliver catheter is removed by nurses in the labor and delivery unit and patients are sent to floor for recovery. Last evaluation will take place on post delivery day number one to evaluate patient satisfaction and address any concern patients may have.
Primary End points:
Primary purpose is to assess the ability of L5/S1 catheter to numb S1 or S2 dermatomes in comparison to routine placement of epidural catheter Secondary outcome to be assessed VAS, catheter manipulation or replacement between the two groups.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound L5/S1 catheter placement | – | –Pt will have back scanned with Ultrasound and L5/S1 interspace localized for epidural placement. |
| Control Group | – | –Patients will have catheter placed after clinically evaluating the back as is done routinely resulting in mid lumbar catheter placement in general. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- active laboring patient without any complication requesting epdiural for pain control
Key inclusion criteria (1 listed)
- Active labor age 18 or older
Key exclusion criteria (3 listed)
- Known contraindications to epidural analgesia
- Any neurologic illness
- Fetal abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1.Blocking of S1 and S2 dermatomes
Time frame: 30 minutes after loading epidural
After test dose and loading up of catheter, s1 and s2 dermatome blockage will be tested in L5/S1 epidural group vs conventionally placed epidural group. Idea is see if higher incidence of S1 and S2 blockage can be demonstrated in low epidural group.
2 secondary outcomes
Number of top up doses for pain control throughout labor
Time frame: from insertion till delivery average 8-24 hrs
Patient satisfaction
Time frame: Evaluated on Post deliver day 1
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 1 Nov 2016.
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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.
TARIQ MALIK, MD principal investigator
University of Chicago
Mohammed Minhaj, MD principal investigator
University of Chicago
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 Labor Pain, run by University of Chicago at 1 site in United States.
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 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 1 Nov 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 United States. 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?
1.Blocking of S1 and S2 dermatomes (time frame: 30 minutes after loading epidural). 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 1 Nov 2016.