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NCT03115151 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.

Terminated
Registry status
Phase 4
Development phase
46
Enrollment target

NCT03115151: Clinical Trial Phase 4 study, sponsored by University of Texas Southwestern Medical Center.

NCT03115151 is a Phase 4 study that was terminated before completion, run by University of Texas Southwestern Medical Center. The registered enrollment target is 46 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03115151, a Phase 4 study, was terminated before completion, sponsored by University of Texas Southwestern Medical Center.

TERMINATED
Registry status
Phase 4
Development phase
46 participants
Enrollment target

Study 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.

Primary Outcome

Postoperative Visual Analog Pain Score following lumbar fusion surgery. VAS on the scale 0 to 100 (0= no pain, 100= worst pain).

Interventions

  • DRUG Bupivacaine
  • DRUG Hydromorphone
  • DRUG Fentanyl

Trial Details

FieldValue
Enrollment Target 46 participants
Start Date 2017-05-08
Est. Completion 2023-04-04
Phase Phase 4

Why NCT03115151 stopped before completion

NCT03115151 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 3 interventions - of which Bupivacaine is the first listed.

NCT03115151 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03115151 about?

NCT03115151 is a clinical study titled "Epidural and Intravenous Patient-Controlled Analgesia Following Lumbar Spinal Fusion Surgery". 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 techni...

What is the current status of trial NCT03115151?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 46 participants. The study started on 2017-05-08. Estimated completion is 2023-04-04.

What interventions are being tested in trial NCT03115151?

The interventions under investigation include: Bupivacaine (DRUG), Hydromorphone (DRUG), Fentanyl (DRUG).

Who is sponsoring clinical trial NCT03115151?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03115151's enrollment target sits among peer trials

46 1348th of 2000 higher than 647 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03115151, the US trial registry maintained by the National Library of Medicine. NCT03115151 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.