Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 12/6/2018 |
| Start Date: | May 8, 2017 |
| End Date: | June 1, 2019 |
| Contact: | Enas Kandil, MD |
| Email: | Enas.Kandil@UTSouthwestern.edu |
| Phone: | 214/648-9374 |
A Comparison of Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery: A Prospective Randomized Study
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.
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.
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.
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.
Inclusion Criteria:
- Adult subjects aged 18 years or older
- Scheduled for elective posterior lumbar spinal fusion surgery between 1 and 3 levels
Exclusion Criteria:
- Baseline cognitive deficits sufficient to make objective pain self-assessments
unreliable in the estimation of the Study Investigators.
- Immunocompromised subject
- Coagulopathy
- Severe liver and renal dysfunction
- Preoperative neurological deficits
- The dura damage during surgery
- 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) or opioid
(fentanyl).
We found this trial at
2
sites
1801 Inwood Rd
Dallas, Texas 75390
Dallas, Texas 75390
(214) 645-3300
Phone: 214-648-9374
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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5151 Harry Hines Boulevard
Dallas, Texas 75390
Dallas, Texas 75390
Phone: 214-645-0629
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