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NCT01588158 · ClinicalTrials.gov registry record · Phase 4

Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery

A Phase 4 study, sponsored by Massachusetts General Hospital.

Terminated
Registry status
Phase 4
Development phase
7
Enrollment target

NCT01588158: Clinical Trial Phase 4 study, sponsored by Massachusetts General Hospital.

NCT01588158 is a Phase 4 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01588158, a Phase 4 study, was terminated before completion, sponsored by Massachusetts General Hospital.

TERMINATED
Registry status
Phase 4
Development phase
7 participants
Enrollment target

Study Summary

Adequate pain relief has been a priority of the Joint Commission and is featured on national inpatient surveys such as the H-CAHPS. When considering methods for improving satisfaction with pain relief in the United States, a great deal of emphasis has been placed on opioid pain medications. Some of this emphasis on opioid pain medication is driven by the pharmaceutical industry and by advocacy groups with ties to the pharmaceutical industry. There is evidence that the "pain is the fifth vital sign" campaign of the Joint Commission led to an increased incidence of prescription of opioids, but there is less evidence of improved satisfaction with pain relief. There is some evidence of an increase in opioid-related adverse events. As the sales of opioids have tripled from 1999-2008, so has the number of deaths caused by opioid overdose; 14,800 in 2008. The number of visits to the Emergency Department for opioid overdose doubled between 2004 and 2008. Patients in other countries take far less opioid pain medication and are equally satisfied with pain relief. For instance, Lindenhovius et al. found in a retrospective study that Dutch patients take a weak (Tramadol) or no opioid pain medication after ankle fracture surgery and have comparable or better satisfaction with pain relief than American patients, most of whom take oxycodone. That study was repeated prospectively (unpublished) and confirmed that Dutch patients do not feel their pain is undertreated. A study of morphine use after a femur fracture demonstrated that American patients used far more than Vietnamese patients (30 mg/kg versus 0.9 mg/kg), but were more dissatisfied with their pain relief. These sociological differences are striking and suggest strongly that personal factors may be the most important determinant of satisfaction with pain relief. It is our impression that most American hand surgeons give patients a prescription for an opioid pain medication after carpal tunnel release, and that is certain

Interventions

  • DRUG Acetaminophen
  • DRUG Vicodin

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2012-07
Est. Completion 2016-01
Phase Phase 4

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT01588158

The ClinicalTrials.gov registry entry for NCT01588158 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

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

NCT01588158 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01588158 about?

NCT01588158 is a clinical study titled "Patient Satisfaction With Pain Relief After Ambulatory Hand Surgery". Adequate pain relief has been a priority of the Joint Commission and is featured on national inpatient surveys such as the H-CAHPS. When considering methods for improving satisfaction with pain relief in the United States, a great deal of emphasis has been placed on opioid pain medications. Some of ...

What is the current status of trial NCT01588158?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 7 participants. The study started on 2012-07. Estimated completion is 2016-01.

What interventions are being tested in trial NCT01588158?

The interventions under investigation include: Acetaminophen (DRUG), Vicodin (DRUG).

Who is sponsoring clinical trial NCT01588158?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

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

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, the data changelog, or report a data error.