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Perioperative Systemic Acetaminophen to Improve Postoperative Quality of Recovery After Ambulatory Breast Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01852955
First Posted: May 14, 2013
Last Update Posted: March 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
Results First Submitted: January 19, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Pain
Interventions: Drug: IV acetaminophen
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
IV Acetaminophen

Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.

IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure

Placebo

Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen

Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen


Participant Flow:   Overall Study
    IV Acetaminophen   Placebo
STARTED   35   35 
COMPLETED   33   32 
NOT COMPLETED   2   3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
IV Acetaminophen

Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.

IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure

Placebo

Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen

Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen

Total Total of all reporting groups

Baseline Measures
   IV Acetaminophen   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 33   32   65 
Age, Customized 
[Units: Years]
Mean (Full Range)
     
Age   60 
 (54 to 65) 
 52 
 (44 to 68) 
 55 
 (44 to 68) 
Gender 
[Units: Participants]
     
Female   33   32   65 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   33   32   65 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Quality of Recovery at 24 Hours(QoR-40 Instrument)   [ Time Frame: 24 hours after the surgical procedure ]

2.  Secondary:   Postoperative Opioid Consumption   [ Time Frame: 24 hour ]

3.  Secondary:   Postoperative Pain in the Post Anesthesia Care Unit   [ Time Frame: Time in the post anesthesia care unit after surgery (average of 5 hours) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gildasio De Oliveira, M.D.
Organization: Northwestern University
phone: 312-695-4858
e-mail: gjr@northwestern.edu


Publications:


Responsible Party: Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier: NCT01852955     History of Changes
Other Study ID Numbers: STU00078104
First Submitted: May 9, 2013
First Posted: May 14, 2013
Results First Submitted: January 19, 2016
Results First Posted: March 14, 2016
Last Update Posted: March 14, 2016