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

The University of Texas System (UT)

Status and phase: Terminated; Phase 4

Conditions: Pain

Treatments: Drug: Hydromorphone; Drug: Fentanyl; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03115151

STU 092016-061

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Patient-Controlled Epidural Analgesia

Experimental group

Description:

Bupivacaine and fentanyl infusion via Continuous Lumbar Epidural Analgesia during postoperative 72 hours

Treatment:

Drug: Bupivacaine

Drug: Fentanyl

Intravenous patient-controlled analgesia

Sham Comparator group

Description:

Postoperative intravenous patient-controlled analgesia (IV PCA) with Hydromorphone

Treatment:

Drug: Hydromorphone