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NCT01433081 · ClinicalTrials.gov registry record · NA

The Effect of Magnesium Sulfate Infusion on the Quality of Recovery of Ambulatory Patients

A NA study of Pain and Opioid Use, Unspecified, Uncomplicated, sponsored by Northwestern University.

Completed
Registry status
NA
Development phase
50
Enrollment target
1
Study location

NCT01433081 is a NA study of Pain and Opioid Use, Unspecified, Uncomplicated that has completed, run by Northwestern University. The registered enrollment target is 50 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01433081, a NA study of Pain and Opioid Use, Unspecified, Uncomplicated, has completed, sponsored by Northwestern University.

COMPLETED
Registry status
NA
Development phase
50 participants
Enrollment target
1
Study location

Study Summary

A national survey has revealed that 80% of patients experienced pain after surgery and 86% of these patients had moderate, severe or extreme pain (1).Postoperative pain can extend recovery room stay after surgery and it is also a common cause of unanticipated admissions which have important economic implications(2).More importantly, postoperative pain can lead to a poor quality of recovery in ambulatory patients. The Intraoperative use of medications that might decrease postoperative pain is therefore highly desirable. Some medications such as lidocaine and ketamine have been proved to decrease postoperative pain when given during the Intraoperative period in ambulatory patients(3,4) but it is still unknown if those medications can in fact lead to a better quality of recovery . Magnesium sulfate is a non-competitive calcium antagonist at the N-methyl-D- aspartate (NMDA) receptor(5). NMDA receptors have an important role on pain modulation (6). The use of Intraoperative magnesium in order to decrease postoperative pain had contradictory results in different studies. Some studies have shown a potential benefit of magnesium in decreasing postoperative pain (7,8) while others have not demonstrated any benefit (9,10). In the ambulatory setting, specifically, Tramer et al. did not find any improvement on postoperative pain after an Intraoperative dose of magnesium for patients undergoing ilioinguinal hernia repair(11). Koinig et al., however, demonstrated a significant reduction in the postoperative analgesic requirements in patients undergoing arthroscopic knee surgery (12). Even though, the reduction of postoperative opioid requirement has been used in many studies in the ambulatory literature, it has been recently questioned by some investigators (13).Patients might take more opioid medications but they may not necessarily develop opioid related side effects such as nausea and vomiting. A more global evaluation of the patient involving several aspects of recovery w

Interventions

  • DRUG Placebo infusion of .9 normal saline
  • DRUG administration of magnesium sulfate

Study Locations (1)

Illinois

  • Prentice Womens Hospital - Chicago

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2011-02
Est. Completion 2013-04
Phase NA

Sponsor

Northwestern University

1,209 total trials

What the Registry Record Tells You About NCT01433081

The ClinicalTrials.gov registry entry for NCT01433081 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (84% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo infusion of .9 normal saline is the first listed.

NCT01433081 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.

Frequently Asked Questions

What is clinical trial NCT01433081 about?

NCT01433081 is a clinical study titled "The Effect of Magnesium Sulfate Infusion on the Quality of Recovery of Ambulatory Patients". A national survey has revealed that 80% of patients experienced pain after surgery and 86% of these patients had moderate, severe or extreme pain (1).Postoperative pain can extend recovery room stay after surgery and it is also a common cause of unanticipated admissions which have important economic...

What is the current status of trial NCT01433081?

This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2011-02. Estimated completion is 2013-04.

What conditions does trial NCT01433081 study?

This clinical trial studies the following conditions: Pain, Opioid Use, Unspecified, Uncomplicated.

What interventions are being tested in trial NCT01433081?

The interventions under investigation include: Placebo infusion of .9 normal saline (DRUG), administration of magnesium sulfate (DRUG).

Who is sponsoring clinical trial NCT01433081?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01433081 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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