Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions

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

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

Conditions
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Lumbar Spine Fusion, Pain, Back Pain

Intervention / Treatment
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* Other: Epidural Catheter - Dilaudid
* Drug: Dilaudid


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous opioids<br>This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control. | Drug: Dilaudid<br>* Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid).<br>|
| Experimental: Epidural Catheter<br>The intervention to be tested in this study against standard intravenous opioids is infusion of local anesthetic and dilaudid via epidural catheter for post-operative pain control in patients undergoing lumbar spine fusion surgery. | Other: Epidural Catheter - Dilaudid<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 6-Week Follow up Visit | 
| Patient Satisfaction With Overall Care | Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied). | 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. | 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. | 6-week Follow up Visit | 
| Total Post-operative Opioid Consumption |  | during hospitalization (approximately 3-8 days) | 
| Number of Participants Experiencing Delirium |  | Post-operative Day 1 | 
| Number of Participants Experiencing Delirium |  | Post-operative Day 2 | 
| Number of Participants Experiencing Delirium |  | Post-operative Day 3 | 
| Number of Participants Readmitted to Hospital Within 30 Days of Surgery |  | Post-operative Day 30 | 
| Length of Hospital Stay |  | during hospitalization (approximately 3-8 days) | 
| Wound Infection Rates |  | during hospitalization (approximately 3-8 days) |