Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions
Stopped early · Phase 3
Conditions studied: Lumbar Spine Fusion, Pain, Back Pain
In brief
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.
Key facts
- Study ID
- NCT01986946
- Run by
- Duke University
- People needed
- 17
- Starts
- 2013-10-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2017-02-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients who are scheduled for elective Transforaminal Lumbar Interbody Fusion surgery
You may not qualify if…
- 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).
Where it is running
- Duke University Hospital — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.