Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions



Status:Terminated
Conditions:Back Pain, Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2013
End Date:September 2015

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Trial Summary
Trial Overview
Inclusion Criteria

A Comparison of Epidural Analgesia With Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study

1. Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar
Spinal Fusion: A Prospective Randomized Study

2. Purpose of the Study - This prospective randomized study will enroll 200 patients
undergoing elective Lumbar Spinal Fusion at Duke University Hospital. The primary
objective is to determine the effect of epidural analgesia, as compared with standard
care, on post-operative analgesia.

Hypothesis:

The investigators hypothesize that patients undergoing Lumbar Spinal Fusion surgery with
epidural catheter placement will have superior post-operative analgesia compared to patients
undergoing standard care.


Inclusion Criteria:

- Adult patients who are scheduled for elective Transforaminal Lumbar Interbody Fusion
surgery

Exclusion Criteria:

- Baseline cognitive deficits sufficient to make objective pain self-assessments
unreliable in the estimation of the Study Investigators.

- Inability to follow directions or comprehend the English language.

- Females who are pregnant as determined by positive pregnancy test on or before the
day of surgery.

- Prisoners.

- Patient refusal to provide informed consent.

- Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine).
We found this trial at
1
site
Duke University Hospital
Durham, North Carolina 27705
?
mi
from
Durham, NC
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