Back to resultsIV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair
Primary Purpose
Pelvic Organ Prolapse
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
IV Acetaminophen
IV normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring IV acetaminophen, Postoperative pain, Pelvic organ prolapse surgery, Pelvic organ prolapse repair
Eligibility Criteria
Inclusion Criteria:
- Women ≥ 18 years of age
- scheduled to undergo surgery for POP via a vaginal or minimally invasive (laparoscopic/robotic) route at the University of Pittsburgh Medical Center
- women anticipated to have a hospital stay ≥24 hours
Exclusion Criteria:
- allergy/intolerance to acetaminophen
- hepatic dysfunction
- significant alcohol use - defined as patient reported consumption of more than 7 standard drinks per week and/or 3 drinks per day
Sites / Locations
- Magee-Womens Hospital of the University of Pittsburgh Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
IV Acetaminophen
Arm Description
100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.
100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.
Outcomes
Primary Outcome Measures
Change From Baseline in Postoperative Pain
VAS or Visual Analog Score is a quantitative measure, in this study, of pain that the subject is currently experiencing. The VAS is presented as a straight line which measures 100mm. The subject is instructed to mark an 'X' through this line reflecting the amount of pain that they are currently experiencing. Zero would indicate no pain, while '100' would indicate the most severe pain ever. Thus the total range for this scale would be 0-100 mm. Higher values indicate more pain; lower value indicate less pain.
For this outcome measure, the VAS scores from Baseline and the VAS scores from 24 hours after the end of surgery are being used. The change from baseline in postoperative pain equals the 24 hour VAS score minus the baseline VAS score.
The Change from Baseline would be the 24-hour VAS score minus the Baseline VAS score. Higher values indicate more pain; lower values indicate less pain.
Cumulative Narcotic Consumption Over the First 24 Hours
Equianalgesic dosage tables will be used to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. Higher numbers indicate higher narcotic usage.
Secondary Outcome Measures
Interference of Pain With Physical, Mental and Social Activities
Interference of pain with physical, mental and social activities will be measured by the Patient Reported Outcomes Measures Information Systems-Pain Interference-Short Form 8a (PROMIS PI-SF-8a) administered on POD#7.
This instrument measures the self reported consequences of pain on relevant aspects of one's life. This scale is considered to be universal rather than disease specific. Each question has five response options ranging in value from 1-5. The total raw score for the scale is the sum of all values. The total raw score can range from 8-40. All questions much be answered to obtain a valid score.
A higher PROMIS score indicates more 'hurt' or pain.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02155738
Brief Title
IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair
Official Title
The Impact of IV Acetaminophen on Postoperative Pain in Women Undergoing Pelvic Organ Prolapse Repair: A Double-Blind Randomized Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Halina M Zyczynski, MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether preoperative IV Acetaminophen reduces postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic organ prolapse.
Detailed Description
This randomized controlled trial of IV Acetaminophen compared to placebo will evaluate the effect of preoperative IV Acetaminophen on postoperative pain scores and narcotic requirements in women undergoing surgical repair of pelvic organ prolapse. 204 women will randomly receive 1000 mg of IV Acetaminophen or saline preoperatively within 30 minutes of surgical incision. Subjects will be offered narcotic and non-narcotic pain medications as needed during the postoperative period. Visual analogue pain scales (VAS) will be obtained at 4, 8, 12, 16, 20 and 24 hours postoperatively. Narcotic consumption will be recorded in morphine-equivalents. We hypothesize that women receiving IV Acetaminophen will have lower VAS scores and decreased narcotic requirements compared to controls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
IV acetaminophen, Postoperative pain, Pelvic organ prolapse surgery, Pelvic organ prolapse repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.
Arm Title
IV Acetaminophen
Arm Type
Experimental
Arm Description
100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.
Intervention Type
Drug
Intervention Name(s)
IV Acetaminophen
Other Intervention Name(s)
Ofirmev
Intervention Type
Drug
Intervention Name(s)
IV normal saline
Other Intervention Name(s)
placebo
Intervention Description
IV normal saline
Primary Outcome Measure Information:
Title
Change From Baseline in Postoperative Pain
Description
VAS or Visual Analog Score is a quantitative measure, in this study, of pain that the subject is currently experiencing. The VAS is presented as a straight line which measures 100mm. The subject is instructed to mark an 'X' through this line reflecting the amount of pain that they are currently experiencing. Zero would indicate no pain, while '100' would indicate the most severe pain ever. Thus the total range for this scale would be 0-100 mm. Higher values indicate more pain; lower value indicate less pain.
For this outcome measure, the VAS scores from Baseline and the VAS scores from 24 hours after the end of surgery are being used. The change from baseline in postoperative pain equals the 24 hour VAS score minus the baseline VAS score.
The Change from Baseline would be the 24-hour VAS score minus the Baseline VAS score. Higher values indicate more pain; lower values indicate less pain.
Time Frame
24 hours
Title
Cumulative Narcotic Consumption Over the First 24 Hours
Description
Equianalgesic dosage tables will be used to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. Higher numbers indicate higher narcotic usage.
Time Frame
First 24 hours
Secondary Outcome Measure Information:
Title
Interference of Pain With Physical, Mental and Social Activities
Description
Interference of pain with physical, mental and social activities will be measured by the Patient Reported Outcomes Measures Information Systems-Pain Interference-Short Form 8a (PROMIS PI-SF-8a) administered on POD#7.
This instrument measures the self reported consequences of pain on relevant aspects of one's life. This scale is considered to be universal rather than disease specific. Each question has five response options ranging in value from 1-5. The total raw score for the scale is the sum of all values. The total raw score can range from 8-40. All questions much be answered to obtain a valid score.
A higher PROMIS score indicates more 'hurt' or pain.
Time Frame
1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women ≥ 18 years of age
scheduled to undergo surgery for POP via a vaginal or minimally invasive (laparoscopic/robotic) route at the University of Pittsburgh Medical Center
women anticipated to have a hospital stay ≥24 hours
Exclusion Criteria:
allergy/intolerance to acetaminophen
hepatic dysfunction
significant alcohol use - defined as patient reported consumption of more than 7 standard drinks per week and/or 3 drinks per day
Facility Information:
Facility Name
Magee-Womens Hospital of the University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30741813
Citation
Turner LC, Zyczynski HM, Shepherd JP. Intravenous Acetaminophen Before Pelvic Organ Prolapse Repair: A Randomized Controlled Trial. Obstet Gynecol. 2019 Mar;133(3):492-502. doi: 10.1097/AOG.0000000000003102.
Results Reference
derived
Learn more about this trial
IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair
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