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

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ClinicalTrials.gov Identifier: NCT01852955
Recruitment Status : Completed
First Posted : May 14, 2013
Results First Posted : March 14, 2016
Last Update Posted : March 14, 2016
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University

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
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IV Acetaminophen Placebo
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 35 35
Completed 33 32
Not Completed 2 3
Arm/Group Title IV Acetaminophen Placebo Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 33 32 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
Age Number Analyzed 33 participants 32 participants 65 participants
60
(54 to 65)
52
(44 to 68)
55
(44 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 32 participants 65 participants
Female
33
 100.0%
32
 100.0%
65
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 33 participants 32 participants 65 participants
33 32 65
1.Primary Outcome
Title Quality of Recovery at 24 Hours(QoR-40 Instrument)
Hide Description Quality of recovery score 24 hours after the surgical procedure. Total score range of 40 (poor recovery) and a score of 200 (good recovery).
Time Frame 24 hours after the surgical procedure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 33 32
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
189
(183 to 194)
183
(175 to 190)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Postoperative Opioid Consumption
Hide Description Postoperative opioid consumption over 24 hours. Converted into oral mg of morpine equivalents.
Time Frame 24 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 33 32
Median (Inter-Quartile Range)
Unit of Measure: oral mg of morpine equivalents
20
(10 to 30)
30
(10 to 40)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IV Acetaminophen, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .04
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Postoperative Pain in the Post Anesthesia Care Unit
Hide Description Postoperative pain within the post anesthesia care unit after surgery. Area under the numeric rating scale for pain versus time curve in the post anesthesia care unit (score * min).Numeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score * min). Area under a curve units of the horizontal axis multiplied by the units of the vertical axis. A higher value indicates more pain and time in the Post Anesthesia Care Unit.The range is 0 pain to x time in minutes x 1 hour to 5 hour ( 60-300 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC.
Time Frame Time in the post anesthesia care unit after surgery (average of 5 hours)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IV Acetaminophen Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 33 32
Median (Inter-Quartile Range)
Unit of Measure: (units on a scale * minutes
255
(225 to 300)
240
(180 to 300)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .36
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Development of nausea 24 hours after surgery.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IV Acetaminophen Placebo
Hide Arm/Group Description

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

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

All-Cause Mortality
IV Acetaminophen Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IV Acetaminophen Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/33 (0.00%)      0/32 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IV Acetaminophen Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/33 (48.48%)      12/32 (37.50%)    
Gastrointestinal disorders     
Vomiting * 1 [1]  3/33 (9.09%)  3 1/32 (3.13%)  1
Nausea * 2 [2]  13/33 (39.39%)  13 11/32 (34.38%)  11
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, Vomiting
2
Term from vocabulary, MedDRA (10.0)
[1]
Vomiting within 24 hours of surgery
[2]
Nausea within 24 hours of surgery
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
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