Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery

  • STATUS
    Recruiting
  • End date
    Dec 4, 2022
  • participants needed
    58
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 24 February 2022
analgesics
analgesia
postoperative pain
bupivacaine
opioid
hydromorphone
epidural analgesia
pain relieving

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.

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.

Details
Condition Pain
Treatment Fentanyl, Hydromorphone, Bupivacaine
Clinical Study IdentifierNCT03115151
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on24 February 2022

Eligibility

Yes No Not Sure

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) allergy if patient assigned epidural analgesia
Hydromorphone allergy if patient assigned IV PCA
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