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IV Acetaminophen for Postoperative Pain Analgesia After Laparoscopic Hysterectomy

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ClinicalTrials.gov Identifier: NCT02400580
Recruitment Status : Completed
First Posted : March 27, 2015
Results First Posted : December 21, 2017
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Noah Rindos, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: IV acetaminophen
Drug: placebo
Enrollment 183
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intravenous IV Acetaminophen Normal Saline
Hide Arm/Group Description

The patients in the treatment arm will receive 1000mg of IV acetaminophen.

IV acetaminophen

The patients in the placebo arm will receive normal saline.

placebo

Period Title: Overall Study
Started 91 92
Completed 89 91
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             1             1
Adverse Event             1             0
Arm/Group Title Intravenous IV Acetaminophen Normal Saline Total
Hide Arm/Group Description

The patients in the treatment arm will receive 1000mg of IV acetaminophen.

IV acetaminophen

The patients in the placebo arm will receive normal saline.

placebo

Total of all reporting groups
Overall Number of Baseline Participants 91 92 183
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 92 participants 183 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
91
 100.0%
92
 100.0%
183
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 92 participants 183 participants
Female
91
 100.0%
92
 100.0%
183
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 91 participants 92 participants 183 participants
91 92 183
1.Primary Outcome
Title Postoperative Pain
Hide Description 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.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous IV Acetaminophen Normal Saline
Hide Arm/Group Description:

The patients in the treatment arm will receive 1000mg of IV acetaminophen.

IV acetaminophen

The patients in the placebo arm will receive normal saline.

placebo

Overall Number of Participants Analyzed 91 92
Mean (95% Confidence Interval)
Unit of Measure: units on a visual analog scale
3.55
(1.08 to 6.02)
3.11
(0.89 to 5.33)
2.Secondary Outcome
Title Narcotic Medication Use
Hide Description 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.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intravenous IV Acetaminophen Normal Saline
Hide Arm/Group Description:

The patients in the treatment arm will receive 1000mg of IV acetaminophen.

IV acetaminophen

The patients in the placebo arm will receive normal saline.

placebo

Overall Number of Participants Analyzed 89 91
Mean (95% Confidence Interval)
Unit of Measure: Morphine Equivalents
16.4
(4.9 to 27.9)
18.4
(6.6 to 30.2)
3.Other Pre-specified Outcome
Title Having a Feeling of General Well-being at One Month
Hide Description 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.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intravenous IV Acetaminophen Normal Saline
Hide Arm/Group Description:

The patients in the treatment arm will receive 1000mg of IV acetaminophen.

IV acetaminophen

The patients in the placebo arm will receive normal saline.

placebo

Overall Number of Participants Analyzed 89 91
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
4.11
(3.13 to 5.09)
4.31
(3.37 to 5.25)
4.Other Pre-specified Outcome
Title Number of Participants Who Vomited Within 24 Hours of Operation
Hide Description 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.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous IV Acetaminophen Normal Saline
Hide Arm/Group Description:

The patients in the treatment arm will receive 1000mg of IV acetaminophen.

IV acetaminophen

The patients in the placebo arm will receive normal saline.

placebo

Overall Number of Participants Analyzed 91 92
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.1%
2
   2.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intravenous IV Acetaminophen, Normal Saline
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.517
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
5.Other Pre-specified Outcome
Title Readiness for Discharge
Hide Description 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.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Intravenous IV Acetaminophen Normal Saline
Hide Arm/Group Description:

The patients in the treatment arm will receive 1000mg of IV acetaminophen.

IV acetaminophen

The patients in the placebo arm will receive normal saline.

placebo

Overall Number of Participants Analyzed 89 91
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
7.76
(5.44 to 9.98)
8.15
(5.97 to 10.33)
6.Other Pre-specified Outcome
Title Nausea Before Surgery as Compared to After Surgery
Hide Description 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.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intravenous IV Acetaminophen Normal Saline
Hide Arm/Group Description:

The patients in the treatment arm will receive 1000mg of IV acetaminophen.

IV acetaminophen

The patients in the placebo arm will receive normal saline.

placebo

Overall Number of Participants Analyzed 91 92
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.69
(-0.56 to 1.94)
0.85
(-0.73 to 2.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intravenous IV Acetaminophen, Normal Saline
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.508
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 18 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intravenous IV Acetaminophen Normal Saline
Hide Arm/Group Description

The patients in the treatment arm will receive 1000mg of IV acetaminophen.

IV acetaminophen

The patients in the placebo arm will receive normal saline.

placebo

All-Cause Mortality
Intravenous IV Acetaminophen Normal Saline
Affected / at Risk (%) Affected / at Risk (%)
Total   0/91 (0.00%)      0/92 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Intravenous IV Acetaminophen Normal Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/91 (1.10%)      0/92 (0.00%)    
Vascular disorders     
In patient hospitalization  [1]  1/91 (1.10%)  1 0/92 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Postoperatively there was concern that the patient had undergone a cerebrovascular accident (CVA). She was withdrawn from the study and admitted to the intensive care unit. An extensive workup was performed with no evidence of any adverse event.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intravenous IV Acetaminophen Normal Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/91 (10.99%)      11/92 (11.96%)    
Gastrointestinal disorders     
Vomiting  [1]  1/91 (1.10%)  1 2/92 (2.17%)  2
Nausea  [2]  8/91 (8.79%)  8 9/92 (9.78%)  9
Nervous system disorders     
Pain  [3]  1/91 (1.10%)  1 0/92 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Patients who reported episode of vomiting at 24 hours
[2]
Reports of nausea with level greater than 2 out of 10 at 24 hours.
[3]
The patient had postoperative pain, withdrew from the study. The second dose of study medication was not given.
The original protocol involved 154 patients with an expected rate of loss to follow up of 10%. Due to higher than expected loss to follow up the number of patients enrolled was increased to 190.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Noah Rindos
Organization: University of Pittsburgh Medical Center
Phone: (412) 641-8769
EMail: rindosnb@upmc.edu
Layout table for additonal information
Responsible Party: Noah Rindos, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02400580     History of Changes
Other Study ID Numbers: PRO13110403
First Submitted: March 18, 2015
First Posted: March 27, 2015
Results First Submitted: July 16, 2017
Results First Posted: December 21, 2017
Last Update Posted: June 13, 2018