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NCT04525898 · ClinicalTrials.gov registry record · Phase 4

Intraoperative Methadone for Postoperative Pain Control After Thoracic Surgery

A Phase 4 study, sponsored by Endeavor Health.

Terminated
Registry status
Phase 4
Development phase
40
Enrollment target

NCT04525898: Clinical Trial Phase 4 study, sponsored by Endeavor Health.

NCT04525898 is a Phase 4 study that was terminated before completion, run by Endeavor Health. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04525898, a Phase 4 study, was terminated before completion, sponsored by Endeavor Health.

TERMINATED
Registry status
Phase 4
Development phase
40 participants
Enrollment target

Study Summary

Pain following surgery continues to be an important adverse outcome that may impact postoperative recovery. Opioids like fentanyl and hydromorphone are the primary medications used to provide analgesia, but paradoxically, may actually worsen pain when administered in the operating room. Methadone is a unique opioid which has N-methyl-D-aspartate (NMDA) receptor blocking properties, which may prevent the development of opioid-induced tolerance and hyperalgesia (increased sensitivity to pain induced by a drug). Studies have demonstrated that methadone reduces the need for analgesic medications and decreases pain after surgery. Furthermore, the addition of methadone to a standard anesthetic has been demonstrated to increase patient satisfaction with pain management and reduce the need for opioid analgesic medications during the first month after surgery. Some investigators have described methadone as a "opioid-sparing opioid" and recommended its use as part of a multimodal pain management strategy. There is a growing interest in reducing the use of traditional opioids in the operating room. The aim of this clinical trial is to compare pain scores and analgesic requirements in two groups of patients; one group will be randomized to receive a small dose of methadone at the start of surgery. The other group will be randomized to receive an equal volume of saline (salt water-control group) at the start of surgery. We hypothesize that patients randomized to be administered methadone at the start of surgery will have less postoperative pain and may require lower doses of pain medications than those given saline-control..

Primary Outcome

Pain scores 24 hours after the surgical procedure

Interventions

  • DRUG Methadone

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2019-10-09
Est. Completion 2021-02-01
Phase Phase 4
Endeavor Health

94 total trials

Why NCT04525898 stopped before completion

NCT04525898 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which Methadone is the first listed.

NCT04525898 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04525898 about?

NCT04525898 is a clinical study titled "Intraoperative Methadone for Postoperative Pain Control After Thoracic Surgery". Pain following surgery continues to be an important adverse outcome that may impact postoperative recovery. Opioids like fentanyl and hydromorphone are the primary medications used to provide analgesia, but paradoxically, may actually worsen pain when administered in the operating room. Methadone is...

What is the current status of trial NCT04525898?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2019-10-09. Estimated completion is 2021-02-01.

What interventions are being tested in trial NCT04525898?

The interventions under investigation include: Methadone (DRUG).

Who is sponsoring clinical trial NCT04525898?

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

How this trial's enrollment target compares

Where NCT04525898's enrollment target sits among peer trials

40 1397th of 2000 higher than 533 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 NCT04525898, the US trial registry maintained by the National Library of Medicine. NCT04525898 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.