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NCT03168958 · ClinicalTrials.gov registry record · Phase 4
Methadone and Quality of Postoperative Recovery
A Phase 4 study of Quality of Recovery Scores, sponsored by Endeavor Health.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 130
- Enrollment target
- 1
- Study location
NCT03168958: Recruiting Phase 4 study of Quality of Recovery Scores, sponsored by Endeavor Health.
NCT03168958 is a Phase 4 study of Quality of Recovery Scores that is actively recruiting participants, run by Endeavor Health. The registered enrollment target is 130 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03168958, a Phase 4 study of Quality of Recovery Scores, is actively recruiting participants, sponsored by Endeavor Health.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 130 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients undergoing cardiac surgery often experience moderate to severe pain in the early postoperative period. A number of methods have been used to help control pain after surgery; however, each of these techniques adds additional costs and risks. A simple and effective way to decrease this pain is to administer a long-acting opioid in the operating room. Methadone is a opioid that can produce analgesia (pain relief) that lasts up to 48 hours when given in large doses (0.3 to 0.4 mg/kg). Previous studies have demonstrated that both pain and requirements for analgesic medications are significantly reduced for up to three days after surgery if methadone is given at induction (the start) of anesthesia. In the study that was performed at Evanston Hospital, cardiac surgical patients who were given methadone also appeared to "feel better" after surgery compared to those given a standard or typical intraoperative opioid. The aim of this randomized clinical trial is to determine whether overall quality of postoperative recovery can be enhanced if methadone is given in the operating room. Quality of recovery will be determined by using a validated scoring system, the QoR 40, which will be given to patients to complete on the first three days after surgery.
Primary Outcome
The QoR 40 scoring system will be used to assess postoperative quality of recovery
Conditions Studied
Interventions
- DRUG Methadone
- DRUG Saline
Study Locations (1)
Illinois
- NorthShore University HealthSystem - Evanston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2018-12-25 |
| Est. Completion | 2021-07-25 |
| Phase | Phase 4 |
What NCT03168958 shows while recruiting
NCT03168958 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Quality of Recovery Scores appearing as the primary indexed condition, and to 2 interventions - of which Methadone is the first listed.
NCT03168958 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT03168958 about?
NCT03168958 is a clinical study titled "Methadone and Quality of Postoperative Recovery". Patients undergoing cardiac surgery often experience moderate to severe pain in the early postoperative period. A number of methods have been used to help control pain after surgery; however, each of these techniques adds additional costs and risks. A simple and effective way to decrease this pain i...
What is the current status of trial NCT03168958?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 130 participants. The study started on 2018-12-25. Estimated completion is 2021-07-25.
What conditions does trial NCT03168958 study?
This clinical trial studies the following conditions: Quality of Recovery Scores.
What interventions are being tested in trial NCT03168958?
The interventions under investigation include: Methadone (DRUG), Saline (DRUG).
Who is sponsoring clinical trial NCT03168958?
This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03168958 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03168958's enrollment target sits among peer trials
130 622nd of 2000 higher than 1,371 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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