IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair
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|ClinicalTrials.gov Identifier: NCT02155738|
Recruitment Status : Completed
First Posted : June 4, 2014
Results First Posted : November 19, 2018
Last Update Posted : November 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pelvic Organ Prolapse||Drug: IV Acetaminophen Drug: IV normal saline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||204 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 Start Date :||July 2014|
|Actual Primary Completion Date :||August 31, 2017|
|Actual Study Completion Date :||August 31, 2017|
Placebo Comparator: Placebo
100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.
Drug: IV normal saline
IV normal saline
Other Name: placebo
Experimental: IV Acetaminophen
100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.
Drug: IV Acetaminophen
Other Name: Ofirmev
- Change From Baseline in Postoperative Pain [ Time Frame: 24 hours ]
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 [ Time Frame: 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.
- Interference of Pain With Physical, Mental and Social Activities [ Time Frame: 1 week ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02155738
|United States, Pennsylvania|
|Magee-Womens Hospital of the University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|