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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid).
Duke University Hospital
Durham, North Carolina, United States
Post-operative Pain as Assessed by Visual Analogue Scale (VAS)
The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.
Time frame: Postoperative day 1
Patient Satisfaction With Perioperative Analgesia
Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
Time frame: Post-operative Day 1
Patient Satisfaction With Perioperative Analgesia
Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit. Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
Time frame: 6-Week Follow up Visit
Patient Satisfaction With Overall Care
Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
Time frame: 6-Week Follow up Visit
Number of Participants With Events of Special Interest
Patients will be assessed for development of a deep vein thrombosis after surgery, and surgical site infection.
Time frame: Post-operative Day 30
Number of Participants With Adverse Events Related to the Study
Patients will be assessed in the recovery room and each day of their epidural or intravenous opioid infusions, and at their surgical follow-up visit.
Time frame: 6-week Follow up Visit
Total Post-operative Opioid Consumption
Time frame: during hospitalization (approximately 3-8 days)
Number of Participants Experiencing Delirium
Time frame: Post-operative Day 1
Number of Participants Experiencing Delirium
Time frame: Post-operative Day 2
Number of Participants Experiencing Delirium
Time frame: Post-operative Day 3
Number of Participants Readmitted to Hospital Within 30 Days of Surgery
Time frame: Post-operative Day 30
Length of Hospital Stay
Time frame: during hospitalization (approximately 3-8 days)
Wound Infection Rates
Time frame: during hospitalization (approximately 3-8 days)
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