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NCT02107339 · ClinicalTrials.gov registry record · Phase 4

Methadone and Hydromorphone For Spinal Surgery

A Phase 4 study, sponsored by Endeavor Health.

Completed
Registry status
Phase 4
Development phase
120
Enrollment target

NCT02107339 is a Phase 4 study that has completed, run by Endeavor Health. The registered enrollment target is 120 participants.

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The verdict

NCT02107339, a Phase 4 study, has completed, sponsored by Endeavor Health.

COMPLETED
Registry status
Phase 4
Development phase
120 participants
Enrollment target

Study Summary

Patients undergoing major spinal surgery continue to experience moderate-to-severe pain during the first 2-3 days following the operative procedure. Pain complicates the recovery process, despite the routine practice of using potent opioid analgesics. The primary reason that pain is poorly controlled in patients undergoing major surgery is that most commonly-used opioids only produce analgesia for 2-4 hours. The intermittent use of these drugs results in periods of time when a patient will experience discomfort (at which time a nurse administers more drug or the button on a patient-controlled analgesic (PCA) system is pressed to deliver more medication). The use of a long-acting opioid may be advantageous in the perioperative setting. Methadone is an opioid that has a median duration of analgesia of 24-36 hours. Therefore, a single dose administered in the operating room may reduce the need for pain medication and improve pain control for the first few postoperative days. The aim of this randomized clinical trial is to examine the effect of methadone (compared to hydromorphone) on postoperative pain management in patients undergoing major spine surgery

Interventions

  • DRUG Methadone
  • DRUG Hydromorphone

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2014-03
Est. Completion 2017-09
Phase Phase 4

Sponsor

Endeavor Health

94 total trials

What the Registry Record Tells You About NCT02107339

The ClinicalTrials.gov registry entry for NCT02107339 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endeavor Health, which has 94 total studies on file at ClinicalTrials.gov.

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

NCT02107339 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02107339 about?

NCT02107339 is a clinical study titled "Methadone and Hydromorphone For Spinal Surgery". Patients undergoing major spinal surgery continue to experience moderate-to-severe pain during the first 2-3 days following the operative procedure. Pain complicates the recovery process, despite the routine practice of using potent opioid analgesics. The primary reason that pain is poorly controlle...

What is the current status of trial NCT02107339?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2014-03. Estimated completion is 2017-09.

What interventions are being tested in trial NCT02107339?

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

Who is sponsoring clinical trial NCT02107339?

This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.