Epidural Loading: High Volume, Low Concentration



Status:Recruiting
Healthy:No
Age Range:18 - 89
Updated:6/18/2016
Start Date:February 2016
End Date:December 2016
Contact:Goran Ristev, MD
Email:goran.ristev@osumc.edu
Phone:614-293-8487

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Epidural Loading With High Volume, Low Concentration Prior to Catheter Insertion: is How You Administer the Volume Important?

This prospective, randomized, single blinded control trial will investigate the effects of
epidural loading with a high volume, low concentration local anesthetic solution via the
epidural needle versus the epidural catheter.

This prospective, randomized, single blinded control trial will investigate the effects of
epidural loading with a high volume, low concentration local anesthetic solution via the
epidural needle versus the epidural catheter. Control patients will receive local anesthetic
in lower volume more concentrated solution via the epidural catheter which is current
standard practice. Outcome measures will include quantifying pain relief with respect to
time using VAS scores. In addition, post delivery patient satisfaction regarding anesthesia
regimen, blood pressure changes, heart rate, anesthetic level, total dose of epidural used
during labor, rescue doses and incidence of fetal bradycardia will be assessed. 35 patients
will be recruited for each of the three arms of the study, totaling 105 patients, in order
to obtain significance when performing statistical analyses following complete enrollment in
the study. The impetus of this study involves investigation of the effects of loading the
epidural space with high volume, low concentration local anesthetic via two different
modalities and studying which method is more efficacious.

Inclusion Criteria:

1. Subjects who have volunteered and consented to participation in the study upon
admission to labor and delivery

2. Parturients in active labor requesting epidural analgesia

3. Uncomplicated pregnancy with a reassuring fetal heart tracing

4. Age greater than or equal to 18 years

Exclusion Criteria:

1. Contraindication to epidural anesthesia

2. Inability to read, comprehend, and sign the informed consent form

3. Fetal intrauterine growth retardation (IUGR)

4. Non-reassuring fetal heart tracing

5. Cervical dilation greater than 7cm

6. Intra-uterine fetal demise

7. History of chronic pain other than in the back

8. Incarcerated patients I. Any patient enrolled in the study in whom there is evidence
of dural puncture during epidural technique (>3 attempts, presence of CSF)

j. Any evidence of high spinal after initial bolus or continuous infusion of high volume,
low concentration local anesthetic solution k. Women undergoing cesarean section
We found this trial at
1
site
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Phone: 614-293-8487
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
?
mi
from
Columbus, OH
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