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NCT01546857 · ClinicalTrials.gov registry record · Phase 4

Effect of Gabapentin on Orthopedic Pain

A Phase 4 study, sponsored by Rutgers, The State University of New Jersey.

Terminated
Registry status
Phase 4
Development phase
34
Enrollment target

NCT01546857: Clinical Trial Phase 4 study, sponsored by Rutgers, The State University of New Jersey.

NCT01546857 is a Phase 4 study that was terminated before completion, run by Rutgers, The State University of New Jersey. The registered enrollment target is 34 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01546857, a Phase 4 study, was terminated before completion, sponsored by Rutgers, The State University of New Jersey.

TERMINATED
Registry status
Phase 4
Development phase
34 participants
Enrollment target

Study Summary

This study is being done to determine if a drug called gabapentin helps in the postoperative management of patients undergoing hip and knee operations. The investigators wish to determine the effect of gabapentin on pain and sleep following surgery. If we can lessen a patient's pain and improve sleep, the patient will be better able to participate in their physical therapy. Gabapentin has already been shown to lessen postoperative pain when given before surgery. In healthy patients, it has also been shown to improve certain aspects of sleep. We hope to identify the effect of the drug, when given after surgery, on patients' pain and sleep.

Primary Outcome

A questionnaire was administered asking participants about the quality of their sleep on the night of surgery asked on postoperative day 1, and on the first postoperative night ( POD 2) . Scored on a scale of zero to 3. Zero meaning poor postoperative sleep and 3 indicating better postoperative sleep.

Interventions

  • DRUG Placebo
  • DRUG Gapabentin

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2012-03
Est. Completion 2016-12
Phase Phase 4

Why NCT01546857 stopped before completion

NCT01546857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).

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

NCT01546857 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01546857 about?

NCT01546857 is a clinical study titled "Effect of Gabapentin on Orthopedic Pain". This study is being done to determine if a drug called gabapentin helps in the postoperative management of patients undergoing hip and knee operations. The investigators wish to determine the effect of gabapentin on pain and sleep following surgery. If we can lessen a patient's pain and improve slee...

What is the current status of trial NCT01546857?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2012-03. Estimated completion is 2016-12.

What interventions are being tested in trial NCT01546857?

The interventions under investigation include: Placebo (DRUG), Gapabentin (DRUG).

Who is sponsoring clinical trial NCT01546857?

This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01546857's enrollment target sits among peer trials

34 1520th of 2000 higher than 473 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 NCT01546857, the US trial registry maintained by the National Library of Medicine. NCT01546857 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.