Trial Outcomes & Findings for Perioperative Systemic Acetaminophen to Improve Postoperative Quality of Recovery After Ambulatory Breast Surgery (NCT NCT01852955)

Results Overview

Quality of recovery score 24 hours after the surgical procedure. Total score range of 40 (poor recovery) and a score of 200 (good recovery).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

70 participants

Primary outcome timeframe

24 hours after the surgical procedure

Results posted on

2016-03-14

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	35	35
Overall Study COMPLETED	33	32
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IV Acetaminophen n=33 Participants 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 n=32 Participants 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 n=65 Participants Total of all reporting groups
Age, Customized Age	60 years n=5 Participants	52 years n=7 Participants	55 years n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	32 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants	32 participants n=7 Participants	65 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours after the surgical procedure

Quality of recovery score 24 hours after the surgical procedure. Total score range of 40 (poor recovery) and a score of 200 (good recovery).

Outcome measures

Outcome measures
Measure	IV Acetaminophen n=33 Participants 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 n=32 Participants 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
Quality of Recovery at 24 Hours(QoR-40 Instrument)	189 units on a scale Interval 183.0 to 194.0	183 units on a scale Interval 175.0 to 190.0

SECONDARY outcome

Timeframe: 24 hour

Postoperative opioid consumption over 24 hours. Converted into oral mg of morpine equivalents.

Outcome measures

Outcome measures
Measure	IV Acetaminophen n=33 Participants 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 n=32 Participants 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
Postoperative Opioid Consumption	20 oral mg of morpine equivalents Interval 10.0 to 30.0	30 oral mg of morpine equivalents Interval 10.0 to 40.0

SECONDARY outcome

Timeframe: Time in the post anesthesia care unit after surgery (average of 5 hours)

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.

Outcome measures

Outcome measures
Measure	IV Acetaminophen n=33 Participants 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 n=32 Participants 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
Postoperative Pain in the Post Anesthesia Care Unit	255 (units on a scale * minutes Interval 225.0 to 300.0	240 (units on a scale * minutes Interval 180.0 to 300.0

Adverse Events

IV Acetaminophen

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	IV Acetaminophen n=33 participants at risk 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 n=32 participants at risk 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
Gastrointestinal disorders Vomiting	9.1% 3/33 • Number of events 3 • Development of nausea 24 hours after surgery.	3.1% 1/32 • Number of events 1 • Development of nausea 24 hours after surgery.
Gastrointestinal disorders Nausea	39.4% 13/33 • Number of events 13 • Development of nausea 24 hours after surgery.	34.4% 11/32 • Number of events 11 • Development of nausea 24 hours after surgery.

Additional Information

Gildasio De Oliveira, M.D.

Northwestern University

Phone: 312-695-4858

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place