Comparison of Ultrasound Guided Low Epidural Catheter Placement With Standard Epidural Catheter Placement

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
Tariq Malik, University of Chicago
ClinicalTrials.gov Identifier:
NCT01182220
First received: May 10, 2010
Last updated: May 25, 2013
Last verified: May 2013
  Purpose
  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.

Condition
Labor Pain

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Comparison of Ultrasound Guided L5/S1 Epidural Catheter Placement With Standard Epidural Catheter Placement: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 1.Blocking of S1 and S2 dermatomes [ Time Frame: 30 minutes after loading epdiural ] [ Designated as safety issue: No ]
    After test dose and loading up of catheter, s1 and s2 dermatome blockage will be tested in L5/S1 epdiural group vs conventially placed epidural group. Idea is see if higher incidence of S1 and S2 blockage can be demonstarted in low epdiural group.


Secondary Outcome Measures:
  • Number of top up doses for pain control throughout labor [ Time Frame: from insertion till delivery avearge 8-24 hrs ] [ Designated as safety issue: No ]
    Better blocking of sacral dermatome should improve pain control and shuld result in clincially significant lower number of boluses.

  • Patient satisfaction [ Time Frame: Evaluated on Post deliver day 1 ] [ Designated as safety issue: No ]
    Improved pain control and less number of boluses should translate into better patient satisfaction


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

active laboring patient without any complication requesting epdiural for pain control

Criteria

Inclusion Criteria:

  • Active labor age 18 or older

Exclusion Criteria:

  • Known contraindications to epidural analgesia
  • Any neurologic illness
  • Fetal abnormalities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01182220

Contacts
Contact: TARIQ MALIK, MD 7738343643 tmalik@dacc.uchicago.edu
Contact: Mohammed Minhaj, MD MMinhaj@dacc.uchicago.edu

Locations
United States, Illinois
University of Chicago Hospitals Recruiting
Chicago, Illinois, United States, 60637
Contact: TARIQ MALIK, MD       tmalik@dacc.uchicago.edu   
Principal Investigator: TARIQ MALIK, MD         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: TARIQ MALIK, MD University of Chicago
Principal Investigator: Mohammed Minhaj, MD University of Chicago
  More Information

No publications provided

Responsible Party: Tariq Malik, Assistant Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT01182220     History of Changes
Other Study ID Numbers: 10-241-B
Study First Received: May 10, 2010
Last Updated: May 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
epidural
labor pain
ultrasound

Additional relevant MeSH terms:
Labor Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014