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NCT01986946 · ClinicalTrials.gov registry record · Phase 3

Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions

A Phase 3 study, sponsored by Duke University.

Terminated
Registry status
Phase 3
Development phase
17
Enrollment target

NCT01986946: Clinical Trial Phase 3 study, sponsored by Duke University.

NCT01986946 is a Phase 3 study that was terminated before completion, run by Duke University. The registered enrollment target is 17 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01986946, a Phase 3 study, was terminated before completion, sponsored by Duke University.

TERMINATED
Registry status
Phase 3
Development phase
17 participants
Enrollment target

Study Summary

1. Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study 2. Purpose of the Study - This prospective randomized study will enroll 200 patients undergoing elective Lumbar Spinal Fusion at Duke University Hospital. The primary objective is to determine the effect of epidural analgesia, as compared with standard care, on post-operative analgesia. Hypothesis: The investigators hypothesize that patients undergoing Lumbar Spinal Fusion surgery with epidural catheter placement will have superior post-operative analgesia compared to patients undergoing standard care.

Primary Outcome

The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.

Interventions

  • OTHER Epidural Catheter - Dilaudid
  • DRUG Dilaudid

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2013-10
Est. Completion 2015-09
Phase Phase 3
Duke University

1,725 total trials

Why NCT01986946 stopped before completion

NCT01986946 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 2 interventions - of which Epidural Catheter - Dilaudid is the first listed.

NCT01986946 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01986946 about?

NCT01986946 is a clinical study titled "Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions". 1. Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study 2. Purpose of the Study - This prospective randomized study will enroll 200 patients undergoing elective Lumbar Spinal Fusion at Duke University Hospital. The prim...

What is the current status of trial NCT01986946?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 17 participants. The study started on 2013-10. Estimated completion is 2015-09.

What interventions are being tested in trial NCT01986946?

The interventions under investigation include: Epidural Catheter - Dilaudid (OTHER), Dilaudid (DRUG).

Who is sponsoring clinical trial NCT01986946?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01986946's enrollment target sits among peer trials

17 1971st of 2000 higher than 27 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT01986946, the US trial registry maintained by the National Library of Medicine. NCT01986946 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.