Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02155738
Recruitment Status : Completed
First Posted : June 4, 2014
Results First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Halina M Zyczynski, MD, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE May 29, 2014
First Posted Date  ICMJE June 4, 2014
Results First Submitted Date  ICMJE August 28, 2018
Results First Posted Date  ICMJE November 19, 2018
Last Update Posted Date November 19, 2018
Study Start Date  ICMJE July 2014
Actual Primary Completion Date August 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 2, 2014)
  • Change From Baseline in Postoperative Pain [ Time Frame: 24 hours ]
    Post operative pain will be assessed at baseline, 4, 8, 12, 16, 20 and 24 hours after surgery. Pain will be self reported by VAS pain scales which range from 0-100mm.
  • Narcotic consumption [ Time Frame: 1 week ]
    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.
Change History Complete list of historical versions of study NCT02155738 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 18, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2014)
  • Patient satisfaction and mood [ Time Frame: 24 hours ]
    To determine the impact of pain control on satisfaction and mood, subjects will be asked to complete the American Pain Society Patient Outcome Questionnaire (APS-POQ-R) on postoperative day (POD) #1.
  • 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.
  • Side effects [ Time Frame: 1 week ]
    Postoperative nausea, pruritus, dizziness and drowsiness will be assessed using the APS-POQ-R questionnaire administered on POD#1. Constipation and time to first bowel movement will be measured with postoperative bowel diaries and the Bristol Stool Scale.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair
Official Title  ICMJE The Impact of IV Acetaminophen on Postoperative Pain in Women Undergoing Pelvic Organ Prolapse Repair: A Double-Blind Randomized Placebo Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pelvic Organ Prolapse
Intervention  ICMJE
  • Drug: IV Acetaminophen
    Other Name: Ofirmev
  • Drug: IV normal saline
    IV normal saline
    Other Name: placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.
    Intervention: Drug: IV normal saline
  • Experimental: IV Acetaminophen
    100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.
    Intervention: Drug: IV Acetaminophen
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2014)
204
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 31, 2017
Actual Primary Completion Date August 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02155738
Other Study ID Numbers  ICMJE PFD-C-14-009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Halina M Zyczynski, MD, University of Pittsburgh
Study Sponsor  ICMJE Halina M Zyczynski, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Pittsburgh
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP