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

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.

Study Overview

• Status: Terminated
• Conditions: Pain
• Intervention / Treatment: Drug: Bupivacaine; Drug: Fentanyl; Drug: Hydromorphone

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Enas Kandil, MD; Phone Number: 214/648-9374; Email: Enas.Kandil@UTSouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390-9068
      • University of Texas Southwestern Medical Center
    • Dallas, Texas, United States, 75390
      • University Of Texas Southwestern Medical Center, Zale University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient-Controlled Epidural Analgesia; Bupivacaine and fentanyl infusion via Continuous Lumbar Epidural Analgesia during postoperative 72 hours	Drug: Bupivacaine; Bupivacaine (0.0625%) will be combined with fentanyl for postoperative epidural analgesia via a lumbar epidural catheter; Other Names: Bupivacaine Hydrochloride; Drug: Fentanyl; Fentanyl (2 mcg/ml) will be given via epidural route together with bupivacaine.; Other Names: Opioid
Sham Comparator: Intravenous patient-controlled analgesia; Postoperative intravenous patient-controlled analgesia (IV PCA) with Hydromorphone	Drug: Hydromorphone; Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL).; Other Names: DILAUDID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Pain Score (VAS)	Postoperative Visual Analog Pain Score following lumbar fusion surgery. VAS on the scale 0 to 100 (0= no pain, 100= worst pain).	VAS score at postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption	Postoperative opioid consumption	Postoperative the first 24 hours

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Study Chair: Enas Kandil, MD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2017
• Primary Completion (Actual): August 18, 2022
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: April 11, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine; Hydromorphone
• Other Study ID Numbers: STU 092016-061

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No