Trial Outcomes & Findings for IV Acetaminophen for Postoperative Pain Analgesia After Laparoscopic Hysterectomy (NCT NCT02400580)

NCT ID: NCT02400580

Last Updated: 2018-06-13

Results Overview

The primary aim of this study is to compare overall post-surgical pain after hysterectomy as reported by the patients on a visual analog scale with a range of 0 to 10 where 0 is no pain at all and 10 is the worst pain that a person can imagine. Less pain is considered preferable to more pain. The theory is that patients who have intravenous acetaminophen will report less post-surgical pain.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 183 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2018-06-13

Participant Flow

Participant milestones

Measure	Intravenous IV Acetaminophen The patients in the treatment arm will receive 1000mg of IV acetaminophen. IV acetaminophen	Normal Saline The patients in the placebo arm will receive normal saline. placebo
Overall Study STARTED	91	92
Overall Study COMPLETED	89	91
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Intravenous IV Acetaminophen The patients in the treatment arm will receive 1000mg of IV acetaminophen. IV acetaminophen	Normal Saline The patients in the placebo arm will receive normal saline. placebo
Overall Study Withdrawal by Subject	1	1
Overall Study Adverse Event	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intravenous IV Acetaminophen n=91 Participants The patients in the treatment arm will receive 1000mg of IV acetaminophen. IV acetaminophen	Normal Saline n=92 Participants The patients in the placebo arm will receive normal saline. placebo	Total n=183 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=91 Participants	0 Participants n=92 Participants	0 Participants n=183 Participants
Age, Categorical Between 18 and 65 years	91 Participants n=91 Participants	92 Participants n=92 Participants	183 Participants n=183 Participants
Age, Categorical >=65 years	0 Participants n=91 Participants	0 Participants n=92 Participants	0 Participants n=183 Participants
Sex: Female, Male Female	91 Participants n=91 Participants	92 Participants n=92 Participants	183 Participants n=183 Participants
Sex: Female, Male Male	0 Participants n=91 Participants	0 Participants n=92 Participants	0 Participants n=183 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	91 participants n=91 Participants	92 participants n=92 Participants	183 participants n=183 Participants

PRIMARY outcome

Timeframe: 24 hours

The primary aim of this study is to compare overall post-surgical pain after hysterectomy as reported by the patients on a visual analog scale with a range of 0 to 10 where 0 is no pain at all and 10 is the worst pain that a person can imagine. Less pain is considered preferable to more pain. The theory is that patients who have intravenous acetaminophen will report less post-surgical pain.

Outcome measures

Measure	Intravenous IV Acetaminophen n=91 Participants The patients in the treatment arm will receive 1000mg of IV acetaminophen. IV acetaminophen	Normal Saline n=92 Participants The patients in the placebo arm will receive normal saline. placebo
Postoperative Pain	3.55 units on a visual analog scale Interval 1.08 to 6.02	3.11 units on a visual analog scale Interval 0.89 to 5.33

SECONDARY outcome

Timeframe: 24 hours

Population: This analysis is of the total number of units of morphine used by each group over a 24 hour period that is composed of the amount of narcotics received in the operating room, recovery room as well as at 6,12, and 24 hours postoperatively.

The secondary outcome is comparison of narcotic pain medical requirements within the first 24 hours after surgery. The hypothesis is that the intravenous acetaminophen group will require less narcotic medications than the placebo group. Narcotic use in this study will be calculated by converting all narcotics (fentanyl, dilaudid etc) into standardized units of morphine using well validated conversion tables.

Outcome measures

Measure	Intravenous IV Acetaminophen n=89 Participants The patients in the treatment arm will receive 1000mg of IV acetaminophen. IV acetaminophen	Normal Saline n=91 Participants The patients in the placebo arm will receive normal saline. placebo
Narcotic Medication Use	16.4 Morphine Equivalents Interval 4.9 to 27.9	18.4 Morphine Equivalents Interval 6.6 to 30.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 weeks

Population: The patients were asked to report their overall feeling of well being on a Visual Analog Scale one month after surgery. The scale has a range from 0 to 10 where a score of 0 would indicate the lowest (best) possible level of an outcome (pain, nausea etc) and a 10 would indicate the highest (worst) possible level.

Quality of recovery will be evaluated through the use of the validated Quality of Recovery-40 questionnaire. The hypothesis is that the intravenous acetaminophen group will experience an increased quality of recovery as compared to the placebo group.

Outcome measures

Measure	Intravenous IV Acetaminophen n=89 Participants The patients in the treatment arm will receive 1000mg of IV acetaminophen. IV acetaminophen	Normal Saline n=91 Participants The patients in the placebo arm will receive normal saline. placebo
Having a Feeling of General Well-being at One Month	4.11 units on a scale Interval 3.13 to 5.09	4.31 units on a scale Interval 3.37 to 5.25

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours

A secondary aim of this study is to compare post-operative vomiting scores on post-operative day zero and one. Vomiting is reported as either having vomited or not vomited. The hypothesis is that the intravenous acetaminophen group will experience decreased vomiting compared with the placebo group.

Outcome measures

Measure	Intravenous IV Acetaminophen n=91 Participants The patients in the treatment arm will receive 1000mg of IV acetaminophen. IV acetaminophen	Normal Saline n=92 Participants The patients in the placebo arm will receive normal saline. placebo
Number of Participants Who Vomited Within 24 Hours of Operation	1 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours

Population: Patients who were asked about overall satisfaction with procedure at time of discharge using a Visual Analog Scale. The scale has a range from 0 to 10 where a score of 0 would indicate the lowest (best) possible level of an outcome (pain, nausea etc) and a 10 would indicate the highest (worst) possible level.

Patient perception of satisfaction at time of discharge on post-operative day zero will be evaluated. The hypothesis is that intravenous acetaminophen group will experience increased satisfaction for discharge than the placebo group.

Outcome measures

Measure	Intravenous IV Acetaminophen n=89 Participants The patients in the treatment arm will receive 1000mg of IV acetaminophen. IV acetaminophen	Normal Saline n=91 Participants The patients in the placebo arm will receive normal saline. placebo
Readiness for Discharge	7.76 units on a scale Interval 5.44 to 9.98	8.15 units on a scale Interval 5.97 to 10.33

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 hours

A secondary aim of this study is to compare post-operative nausea on post-operative day zero and one as reported by the patients on a visual analog scale with a range of 0 to 10 where 0 is no nausea at all and 10 is the worst nausea that a person can imagine. Less nausea is considered preferable to more nausea. The hypothesis is that the intravenous acetaminophen group will experience decreased nausea compared with the placebo group.

Outcome measures

Measure	Intravenous IV Acetaminophen n=91 Participants The patients in the treatment arm will receive 1000mg of IV acetaminophen. IV acetaminophen	Normal Saline n=92 Participants The patients in the placebo arm will receive normal saline. placebo
Nausea Before Surgery as Compared to After Surgery	0.69 units on a scale Interval -0.56 to 1.94	0.85 units on a scale Interval -0.73 to 2.43

Adverse Events

Intravenous IV Acetaminophen

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intravenous IV Acetaminophen n=91 participants at risk The patients in the treatment arm will receive 1000mg of IV acetaminophen. IV acetaminophen	Normal Saline n=92 participants at risk The patients in the placebo arm will receive normal saline. placebo
Vascular disorders In patient hospitalization	1.1% 1/91 • Number of events 1 • 18 months	0.00% 0/92 • 18 months

Other adverse events

Measure	Intravenous IV Acetaminophen n=91 participants at risk The patients in the treatment arm will receive 1000mg of IV acetaminophen. IV acetaminophen	Normal Saline n=92 participants at risk The patients in the placebo arm will receive normal saline. placebo
Gastrointestinal disorders Vomiting	1.1% 1/91 • Number of events 1 • 18 months	2.2% 2/92 • Number of events 2 • 18 months
Nervous system disorders Pain	1.1% 1/91 • Number of events 1 • 18 months	0.00% 0/92 • 18 months
Gastrointestinal disorders Nausea	8.8% 8/91 • Number of events 8 • 18 months	9.8% 9/92 • Number of events 9 • 18 months

Additional Information

Dr. Noah Rindos

University of Pittsburgh Medical Center

Phone: (412) 641-8769

Email: rindosnb@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place