Clinical Trial: Comparison of Ultrasound Guided Low Epidural Catheter Placement With Standard Epidural Catheter Placement

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Comparison of Ultrasound Guided L5/S1 Epidural Catheter Placement With Standard Epidural Catheter Placement: A Randomized Trial

Brief 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.

Detailed Summary:

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 speci
Sponsor: University of Chicago

Current 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.


Original Primary Outcome: 1.Blocking of S1 and S2 dermatomes [ Time Frame: 30 minutes after loading epdiural ]

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.


Current Secondary Outcome:

  • Number of top up doses for pain control throughout labor [ Time Frame: from insertion till delivery average 8-24 hrs ]
    Better blocking of sacral dermatome should improve pain control and should result in clinically significant lower number of boluses.
  • Patient satisfaction [ Time Frame: Evaluated on Post deliver day 1 ]
    Improved pain control and less number of boluses should translate into better patient satisfaction


Original Secondary Outcome:

  • Number of top up doses for pain control throughout labor [ Time Frame: from insertion till delivery avearge 8-24 hrs ]
    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 ]
    Improved pain control and less number of boluses should translate into better patient satisfaction


Information By: University of Chicago

Dates:
Date Received: May 10, 2010
Date Started: January 2013
Date Completion:
Last Updated: October 31, 2016
Last Verified: October 2016