Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2026-01-02 @ 6:12 PM
Study NCT ID:
NCT03115151
Status:
TERMINATED
Last Update Posted:
2023-10-26
First Post:
2017-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
A Comparison of Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery: A Prospective Randomized Study
Status:
TERMINATED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The surgical team has difficulty to find level 1 and 2 fusions for the study.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Postoperative analgesia following spine surgery is difficult to manage. Current treatment modalities rely heavily on opioid analgesics with all of the inherent limitations and side effects. While current best practice focuses on a 'multimodal approach' (i.e. using multiple different drugs and techniques to control pain after surgery), there is no consensus regarding which components of this multimodal therapy provide optimal analgesia. This prospective randomized study will enroll patients undergoing elective Lumbar Spinal Fusion Surgery at Zale Lipshy University Hospital. The primary objective is to determine the comparative efficacy of epidural analgesia, as compared with intravenous (IV) patient-controlled analgesia (PCA), on post-operative analgesia.
Detailed Description:
Study Design: Prospective study of 58 subjects undergoing elective Lumbar Spinal Fusion (1-3 levels- posterior approach) at UTSW Zale Lipshy University Hospital with:
1. Continuous Lumbar Epidural Analgesia (Patient-Controlled Epidural Analgesia- PCEA groups)
2. Intravenous Patient-Controlled Analgesia (IV PCA)
Study Interventions - The intervention to be evaluated in this study is epidural analgesia using an infusion of 0.0625% bupivacaine plus fentanyl 2mcg/ml. The epidural infusion will be continued until it is appropriate to transition the patient to a regimen of oral pain medications. Duration of epidural catheter will be 72 hours a postoperatively.
For subjects in the IV PCA group, the intervention will include post-operative IV PCA with Hydromorphone.
Epidural catheters will be placed by the spine surgeon under direct visualization intra-operatively prior to closing the surgical incision. Intra-operative epidural catheter placement by the spine surgeon will typically be done at the upper end of the dural exposure/laminectomy.
Epidurals will be assessed for efficacy/function in the recovery room post-operatively by the APS, and then daily on the floor post-operatively (unless contacted by the floor nurse regarding specific concerns).
Visual analog pain scale (VAS) will be used to evaluate degree of pain at 3, 24, 48, and 72 hours after surgery.
Additionally, both the IV PCA and the epidural PCEA groups may be given additional "rescue" pain medications as needed in the recovery room, and these may be continued through the post-operative period on the floor.
Total study duration is approximately 50 days, which starts from operating room admission for spinal fusion surgery to the first follow-up visit after discharge.
1. Continuous Lumbar Epidural Analgesia (Patient-Controlled Epidural Analgesia- PCEA groups)
2. Intravenous Patient-Controlled Analgesia (IV PCA)
Study Interventions - The intervention to be evaluated in this study is epidural analgesia using an infusion of 0.0625% bupivacaine plus fentanyl 2mcg/ml. The epidural infusion will be continued until it is appropriate to transition the patient to a regimen of oral pain medications. Duration of epidural catheter will be 72 hours a postoperatively.
For subjects in the IV PCA group, the intervention will include post-operative IV PCA with Hydromorphone.
Epidural catheters will be placed by the spine surgeon under direct visualization intra-operatively prior to closing the surgical incision. Intra-operative epidural catheter placement by the spine surgeon will typically be done at the upper end of the dural exposure/laminectomy.
Epidurals will be assessed for efficacy/function in the recovery room post-operatively by the APS, and then daily on the floor post-operatively (unless contacted by the floor nurse regarding specific concerns).
Visual analog pain scale (VAS) will be used to evaluate degree of pain at 3, 24, 48, and 72 hours after surgery.
Additionally, both the IV PCA and the epidural PCEA groups may be given additional "rescue" pain medications as needed in the recovery room, and these may be continued through the post-operative period on the floor.
Total study duration is approximately 50 days, which starts from operating room admission for spinal fusion surgery to the first follow-up visit after discharge.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: